CAM 60123

Diagnosis and Treatment of Non-Surgical Sacroiliac Joint Pain

Category:Radiology   Last Reviewed:February 2020
Department(s):Medical Affairs   Next Review:February 2021
Original Date:February 2013    

Description:
Sacroiliac joint (SIJ) arthrography using fluoroscopic guidance with an injection of an anesthetic has been explored as a diagnostic test for SIJ pain. Duplication of the patient’s pain pattern with the injection of contrast medium suggests a sacroiliac etiology, as does relief of chronic back pain with injection of local anesthetic. Treatment of SIJ pain with corticosteroids, radiofrequency ablation (RFA), stabilization, or minimally invasive SIJ fusion has also been explored.

Diagnostic
For individuals who have suspected SIJ pain who receive a diagnostic sacroiliac block, the evidence includes systematic reviews. Relevant outcomes are test validity, symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Current evidence is conflicting on the diagnostic utility of SIJ blocks. The evidence is insufficient to determine the effects of the technology on health outcomes.

Clinical input obtained in 2014 supported the use of controlled diagnostic blocks with at least 75% pain reduction for diagnosis of sacroiliac pain. Based on clinical input and the established use of injections to diagnose pain in other joints, controlled diagnostic (2 blocks with anesthetics of different duration) may be considered medically necessary for the diagnosis of SIJ pain.

Therapeutic
For individuals who have SIJ pain who receive therapeutic corticosteroid injections, the evidence includes small randomized controlled trials (RCTs) and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. In general, the literature on injection therapy of joints in the back is of poor quality. Results from 2 small RCTs showed that therapeutic SIJ steroid injections were not as effective as other active treatments. Larger trials, preferably using sham injections, are needed to determine the degree of benefit of corticosteroid injections over placebo. The evidence is insufficient to determine the effects of the technology on health outcomes.

Clinical input obtained in 2014 supported the use of corticosteroids for the treatment of SIJ pain. Based on clinical input and the established use of injections to treat pain in other joints, therapeutic (corticosteroid) injections may be considered medically necessary for the treatment of SIJ pain.

For individuals who have SIJ pain who receive RFA, the evidence includes 4 small RCTs using different radiofrequency applications and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. For RFA with a cooled probe, the 2 small RCTs reported short-term benefits, but these are insufficient to determine the overall effect on health outcomes. The RCT on palisade RFA of the SIJ did not include a sham control. Another sham-controlled randomized trial showed no benefit of RFA. Further high-quality controlled trials are needed to compare this procedure in defined populations with sham control and alternative treatments. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have SIJ pain who receive SIJ fixation/fusion with a triangular implant, the evidence includes 2 nonblinded RCTs of minimally invasive fusion and 2 case series with more than 85% follow-up at 2 to 3 years. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Both RCTs reported superior short-term results for fusion, however, a preferable design for assessing pain outcomes would be independent, blinded assessment of outcomes or, when feasible, a sham-controlled trial. Longer term follow-up from these RCTs has indicated that the results obtained at 6 months persist to 2 years. An additional cohort study and case series, with sample sizes ranging from 45 to 149 patients and low dropout rates (<15%), have also shown reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to 5 years. The cohort studies and case series are consistent with the durability of treatment benefit. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and the cumulative revision rate at 4 years of 3.54%. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Clinical input obtained in 2017 supports that the following indication provides a clinically meaningful improvement in net health outcome and is consistent with generally accepted medical practice:

  • Use of fusion/stabilization of the sacroiliac joint using percutaneous and minimally invasive techniques for carefully selected patients as outlined in statements from the North American Spine Society.

For individuals who have SIJ pain who receive SIJ fusion/fixation with a cylindrical threaded implant, the evidence includes a prospective cohort. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The prospective cohort study will follow patients for 2 years following implantation of slotted screws filled with autologous bone. Results at 1 year are consistent with findings from the studies using a triangular implant. However, longer follow-up and controlled trials are needed to evaluate this type of implant. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background   
SACROILIAC JOINT PAIN
Similar to other structures in the spine, it is assumed that the sacroiliac joint (SIJ) may be a source of low back pain. In fact, before 1928, the SIJ was thought to be the most common cause of sciatica. In 1928, the role of the intervertebral disc was elucidated, and from that point forward, the SIJ received less research attention.

Diagnosis
Research into SIJ pain has been plagued by lack of a criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, SIJ pain is typically without any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for SIJ pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the patient. Further confounding study of the SIJ is that multiple structures, (eg, posterior facet joints, lumbar discs) may refer pain to the area surrounding the SIJ.

Because of inconsistent information obtained from history and physical examination, some have proposed the use of image-guided anesthetic injection into the SIJ for the diagnosis of SIJ pain. Treatments being investigated for SIJ pain include prolotherapy (see evidence review 20126), corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis. Some procedures have been referred to as SIJ fusion but may be more appropriately called fixation (this is because there is little to no bridging bone on radiographs). Devices for SIJ fixation/fusion that promote bone ingrowth to fixate the implants include a triangular implant (iFuse Implant System) and cylindrical threaded devices (Rialto, SImmetry, Silex, SambaScrew, SI-LOK). Some devices also have a slot in the middle where autologous or allogeneic bone can be inserted. This added bone is intended to promote fusion of the SIJ.  

Regulatory Status
A number of radiofrequency generators and probes have been cleared for marketing through the U.S. Food and Drug Administration’s (FDA) 510(k) process. One device, the SInergy® by Kimberly Clark/Baylis, is a water-cooled single-use probe that received FDA clearance in 2005, listing the Baylis Pain Management Probe as a predicate device. The intended use is in conjunction with a radiofrequency generator to create radiofrequency lesions in nervous tissue.

Several percutaneous or minimally invasive fixation/fusion devices have received marketing clearance by FDA. These include the SI-FIX Sacroiliac Joint Fusion System (Medtronic), the IFUSE® Implant System (SI Bone), the SImmetry® Sacroiliac Joint Fusion System (Zyga Technologies), SilexSacroiliac JointFusion System (X-Spine Systems) and the SI-LOK® Sacroiliac Joint Fixation System (Globus Medical).
FDA Product Code: OUR.

Related Policies
20126 Prolotherapy

60125 Percutaneous Vertebroplasty and Sacroplasty
701116 Facet Joint Denervation
187  Sacroiliac Joint Fusion or Stabilization

Policy
Arthrography of the sacroiliac joint is investigational and/or unproven and is therefore considered NOT MEDICALLY NECESSARY.

Injection of corticosteroid may be considered MEDICALLY NECESSARY for the treatment of sacroiliac joint pain when the following criteria have been met:  

  • Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; AND
  • The injection is performed under imaging guidance; AND
  • No more than 3 injections are to be  given in one year: one diagnostic injection will be considered medically necessary and 2 thereapeutic injections will be considered medically necessary if the following criteria are met: the second therapeutic injection is >/= to 4 weeks with at least a 75% reduction in pain relief from the first injection.
  • If the diagnostic injection is negative, any further injections will be considered NOT MEDICALLY NECESSARY. 

The use of cooled radiofrequency denervation(Sinergy®) for a member with sacroiliac joint pain is considered medically necessary when the following conditions have been met: 

  1. Duration of sacroiliac joint pain is greater than 3 months, and
  2. Physical signs and symptoms consistent with a diagnosis of sacroiliac joint pain syndrome are present which may include:
    1. Axial lower back, groin or buttock pain, or referred pain to the ipsilateral leg and foot or lower abdomen, and
    2. Tenderness overlying the sacroiliac joint(s), and
    3. Positive findings for any 3 or more of the following confirmatory clinical diagnostic tests for sacroiliac joint pain such as: 

                                                          i.       Compression test (Approximation test)
                                                          ii.      Distraction test (Gapping test)
                                                          iii.     Gaenslen’s test (right and/or left)
                                                          iv.     Thigh thrust test (Ostergaard’s test)
                                                          v.      Sacral thrust, and 

  1. Conservative treatment has been initiated, sustained and failed. Conservative treatment may be defined by any of the following:
    1. No clinically meaningful improvement from prescription drugs such as NSAIDS and/or muscle relaxants for 6 weeks after the start of the pain, or
    2. No clinically meaningful improvement from conservative self-care (muscle stretching, OTC medications, regular exercise) for 6 weeks after the start of the pain, or
    3. No clinically meaningful improvement from a prescribed and reasonably followed physical therapy core strengthening program (6 weeks) and
  2. Diagnostic sacroiliac joint injection or medial and lateral branch blocks to the sacroiliac joint have:
    1. Two diagnostic block procedures at the location of the planned ablation with documented 75% or greater pain relief as measured by the numerical rating scale (NRS) where “10” is the worst pain imaginable and “0” is no pain at all, within 7 days of the diagnostic block, or other equivalent pain scale, and
    2. A return to the pre-injection pain levels within 2 months of each diagnostic block, and
    3. Demonstrated pain relief is not attributable to the initiation of additional new physical or pharmacologic therapies, and
    4. The pain, signs and symptoms that led to the sacroiliac joint injection have returned in spite of adherence to supportive treatment such as structured exercise or therapy program, and
  3. The procedure is planned with fluoroscopic guidance. However, CT guidance may be used if fluoroscopy is not available in the patient’s geographic area OR the patient’s anatomy and circumstances make fluoroscopy ineffective for guidance.
  4. No more than 2 Cooled RF interventions per year are considered medically necessary. 

Radiofrequency ablation, other than cooled radiofrequency ablation, of the sacroiliac joint is investigational and/or unproven and is therefore considered NOT MEDICALLY NECESSARY.

Policy Guidelines
This policy does not address treatment of pain in the sacroiliac joint due to infection, trauma, or neoplasm. This policy also does not address surgical treatment (SI joint fusion or stabilization).

Conservative nonsurgical therapy for the duration specified should include the following:  

  • Use of prescription strength analgesics for several weeks at a dose sufficient to induce a therapeutic response
    • Analgesics should include anti-inflammatory medications with or without adjunctive medications such as nerve membrane stabilizers or muscle relaxants AND
  • Participation in at least 6 weeks of physical therapy (including active exercise) or documentation of why the patient could not tolerate physical therapy, AND
  • Evaluation and appropriate management of associated cognitive, behavioral, or addiction issues
  • Documentation of patient compliance with the preceding criteria.  

A successful trial of controlled diagnostic lateral branch blocks consists of 2 separate positive blocks on different days with local anesthetic only (no steroids or other drugs), or a placebo-controlled series of blocks, under fluoroscopic guidance, that has resulted in a reduction in pain for the duration of the local anesthetic used (e.g., 3 hours longer with bupivacaine than lidocaine). There is no consensus on whether a minimum of 50% or 75% reduction in pain would be required to be considered a successful diagnostic block, although evidence that supported a criterion standard of 75% to 100% reduction in pain with dual blocks. No therapeutic intra-articular injections (ie, steroids, saline, other substances) should be administered for a period of at least 4 weeks before the diagnostic lateral branch block. The diagnostic blocks should not be conducted under intravenous sedation unless specifically indicated (eg, the patient is unable to cooperate with the procedure).  

CODING
The CPT code for injection into the sacroiliac joint is:  

27096: Injection procedure for sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy or CT) including arthrography when performed  

Code 27096 is used only if the computed tomography (CT) or fluoroscopic imaging is used to confirm the intra-articular needle positioning.  

If the procedure is performed without CT or fluoroscopic imaging guidance, it would be reported using code 20552 – Injection(s); single or multiple trigger point(s), 1 or 2 muscle(s).  

There is no specific CPT code for radiofrequency ablation of the sacroiliac joint. Code 27299 – unlisted procedure, pelvis or hip joint – would likely be used.  

There is a CPT category I code for percutaneous or minimally invasive stabilization: 

27279: Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device.  

Open sacroiliac joint arthrodesis would be reported with CPT code 27280 – Arthrodesis, open, sacroiliac joint, including obtaining bone graft, including instrumentation, when performed.  

For both codes 27279 and 27280, if the procedure is performed bilaterally, the codes would be reported with a -50 modifier.  

Rationale
DIAGNOSIS OF SACROILIAC JOINT PAIN
Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

The use of diagnostic blocks to evaluate sacroiliac joint (SIJ) pain builds on the use of diagnostic blocks to evaluate pain in other joints. Blinded studies with placebo controls,although difficult to conduct when dealing with invasive procedures, are ideally required for scientific validation of SIJ blocks, particularly when dealing with pain relief well-known to respond to placebo controls. In the typical evaluation of a diagnostic test, the results of the sacroiliac diagnostic block would then be compared with a criterion standard. However, no current criterion standard for SIJ disease exists. In fact, some have positioned SIJ injection as the criterion standard against which other diagnostic tests and physical exam may be measured.1, Ultimately, the point of diagnosis is to select patients appropriately for treatment that improves outcomes. Diagnostic tests that differentiate patients who do or do not benefit from a particular treatment are clinically useful.

Clinical Context and Test Purpose
The purpose of diagnostic SIJ block in patients who have suspected SIJ pain is to inform a decision whether to proceed to appropriate treatment.

The question addressed in this evidence review is: Does the use of a diagnostic SIJ block improve the net health outcome in patients who have suspected SIJ pain?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest are individuals with suspected SIJ pain.

Interventions
The test being considered is a diagnostic SIJ block. Sacroiliac blocks are administered under imaging guidance using a local anesthetic in an outpatient setting.

Comparators
The following practice is currently being used to diagnose SIJ pain: standard of care, which can include physical provocative tests to induce pain and diagnostic imaging. SIJ pain confirmed with at least 3 physical provocative tests and ≥50% acute decrease in pain upon SIJ diagnostic block following failed conservative management reflect typical criteria.

Outcomes
The general outcomes of interest are an accurate diagnosis, reductions in pain and medication usage, improvement in functional outcomes (eg, activities of daily living), improvement in the quality of life (QOL), and adverse events. A diagnostic result should be available within one to two hours postinjection.

Study Selection Criteria
For the evaluation of the clinical validity of a diagnostic SIJ block, studies that meet the following eligibility criteria were considered:

  • Reported on the accuracy of the marketed version of the technology (including any algorithms used to calculate scores)
  • Included a suitable reference standard (including a description of the reference standard)
  • Patient/sample clinical characteristics were described
  • Patient/sample selection criteria were described

Technically Reliable
Assessment of technical reliability focuses on specific tests and operators and requires a review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this evidence review and alternative sources exist. This evidence review focuses on the clinical validity and clinical utility.

Clinically Valid
A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Simopoulous et al (2015) conducted a systematic review evaluating 11 diagnostic accuracy studies.2, Studies were heterogeneous in patient selection, SIJ block procedure, assessment, and pain relief cutoff thresholds for diagnosis confirmation, which ranged from 50 to 90% reduction in pain. Four studies utilizing single blocks assessed at a cutoff threshold of at least a 75% decrease in pain score were found to have variable SIJ pain prevalence estimates of 10% to 64%. Eight studies utilizing dual blocks assessed at a cutoff threshold of at least a 70% decrease in pain score were found to have variable SIJ pain prevalence estimates of 10% to 40.4% with corresponding false-positive rates of 22% to 26%. The evidence for dual blocks was graded Level II.

Manchikanti et al (2013) updated an evidence review with guidelines on the diagnosis of SIJ pain for the American Society of Interventional Pain Physicians.3, Various studies evaluating diagnostic blocks were reviewed in which the criteria for a positive test varied from 50% to 100% relief from either single or dual blocks. The most stringent criterion (75% to 100% relief with dual blocks) was evaluated in 7 studies. The prevalence of a positive test in the 7 studies ranged from 10% to 44.4% in patients with suspected sacroiliac disease. The evidence for diagnostic sacroiliac intra-articular injections was considered to be good using 75% to 100% pain relief with single or dual blocks as the criterion standard.

Manchikanti et al (2010) published 2 systematic reviews for interventional techniques for treatment and diagnosis of low back pain.4,5, Evidence for diagnostic sacroiliac injections was considered to be fair to poor, and no additional literature was identified since a systematic review by Rupert et al (2009).6,

Chou et al (2009) conducted 2 systematic reviews at the Oregon Evidence-based Practice Center that informed practice guidelines from the American Pain Society.7,8, The systematic reviews concluded that no reliable evidence existed to evaluate the validity or utility of diagnostic SIJ block as a diagnostic procedure for low back pain with or without radiculopathy, with a resulting guideline recommendation of insufficient evidence. Data on SIJ steroid injection were limited to a small controlled trial, resulting in a recommendation of insufficient evidence for therapeutic injection of this joint.

Clinically Useful
A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence
Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials (RCTs).

Direct evidence supporting the clinical utility of using diagnostic SIJ blocks in this population were not identified.

Chain of Evidence
Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Because the clinical validity of diagnostic SIJ blocks has not been established, a chain of evidence cannot be constructed.

Section Summary: Diagnosis of Sacroiliac Joint Pain
Findings from systematic reviews assessing the utility of diagnostic SIJ blocks are conflicting. In addition, there is no independent reference standard for the diagnosis of SIJ pain.

Treatment of SIJ Pain
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, QOL, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is abalance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The RCT is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Systematic Reviews
Hansen et al (2012) published a systematic review of SIJ interventions.9, The primary outcome was short-term (≤6 months) or long-term (>6 months) pain relief. Evidence was classified as good, fair, or limited/poor based on the quality of evidence. Eleven studies (six randomized, five nonrandomized trials) met the inclusion criteria. Reviewers found that evidence for intra-articular steroid injections was limited or poor, as was the evidence for periarticular injections (local anesthetic and steroid or botulinum toxin). For radiofrequency neurotomy, the evidence for cooled radiofrequency was fair (two RCTs), while evidence for conventional radiofrequency or pulsed radiofrequency was limited or poor. The American Society of Interventional Pain Physicians' (2013) evidence review by Manchikanti et al (2013)3, found no additional studies on intra-articular or periarticular injections besides those identified by Hansen et al (2012).

Treatment of SIJ Pain: Therapeutic Corticosteroid Injections
Clinical Context and Therapy Purpose
The purpose of therapeutic corticosteroid injections is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of therapeutic corticosteroid injections improve the net health outcome in individuals with SIJ pain?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest are individuals with SIJ pain.

Interventions
The therapy being considered is a therapeutic corticosteroid injection.

Comparators
The following therapy is currently being used to treat SIJ: conservative management, including physical therapy.

Outcomes
The general outcomes of interest are symptoms (eg, reductions in pain), functional outcomes, QOL, reductions in medication use, and treatment-related morbidity. Follow-up at 3 to 15 months is of interest to monitor outcomes.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.

Randomized Controlled Trials
The available literature on therapeutic corticosteroid injections is limited, consisting of small RCTs and case series. Tables 1 and 2 summarize the characteristics and results of select RCTs.

A trial by Visser et al (2013) randomized 51 patients with SIJ and leg pain to physical therapy, manual therapy, or intra-articular injection of corticosteroid.10, Diagnosis of SIJ pain was based on provocation tests and not SIJ injections. In a blinded assessment, 25 (56%) patients were considered to be successfully treated at the 12-week follow-up visit based on complete relief of pain and improvement in the visual analog scale (VAS) score for pain.

Kim et al (2010) reported a randomized, double-blind, controlled trial of intra-articular prolotherapy (see evidence review 2.01.26) compared with steroid injection for SIJ pain.11, The trial included 48 patients with SIJ pain. Intra-articular dextrose water prolotherapy or steroid injections were administered under fluoroscopic guidance on a biweekly schedule, with a maximum of 3 injections. Injections were stopped when pain relief was 90% or greater, which required a mean of 2.7 prolotherapy injections and 1.5 steroid injections. Pain (numeric rating scale) and disability (Oswestry Disability Index [ODI]) scores were assessed at baseline, two weeks, and then monthly on completing treatment. At the two-week follow-up, pain and disability scores were significantly improved in both groups, with no significant difference between groups. The numeric rating scale pain score improved from 6.3 to 1.4 in the prolotherapy group and from 6.7 to 1.9 in the steroid group. At 6 months after treatment, 63.6% of patients in the prolotherapy group remained improved from baseline (≥50%), compared with 27.2% in the steroid group. At the 15-month follow-up, the cumulative incidence of sustained pain relief was 58.7% in the prolotherapy group compared with 10.2% in the steroid group. The median duration of the recurrence of severe SIJ pain was three months for the steroid group.

Table 1. Characteristics of Key RCTs Assessing Therapeutic Corticosteroid Injection

Study

Countries

Sites

Dates

Participants

Interventions

 

 

 

 

 

Active

Comparator

Visser et al (2013)10

NL

1

NR

Diagnosed with SIJ pain and/or leg pain between 4 wk and 1 y in duration

18 patients randomized to IA injection

15 patients randomized to PT and 18 to manual therapy

Kim et al (2010)11

Korea

1

NR

Diagnosed with SIJ paina who failed additional 1-mo treatment

24 patients randomized to IA prolotherapy; 23 analyzed

26 patients randomized to steroid; 26 analyzed

 IA: intra-articular; NL: The Netherlands; NR: not reported; PT: physical therapy; RCT: randomized controlled trial; SIJ: sacroiliac joint.
 a Confirmed by ≥50% improvement in response to a single local anesthetic block.

Table 2. Results of Key RCTs Assessing Therapeutic Corticosteroid Injection 

Study

Pain Outcomes

Functional Outcomes

Visser et al (2013)10,

VAS (SD)

RAND-36 Physical Functioning1

Baseline

3 Months

Baseline

3 Months

Intra-articular Corticosteroid Injection

5.7 (1.7)

5.0 (1.9)

45.3 (16.8)

37.9 (15.4)

Physical therapy

4.3 (1.2)

3.9 (1.4)

27.5 (6.5)

51.25 (28.7)

Manual therapy

5.2 (1.4)

3.3 (2.3)

30.0 (18.6)

60.5 (24.3)

Kim et al (2010)11,

NRS (SD)

ODI (SD)

Baseline

2 Weeks

Baseline

2 Weeks

Steroid

6.7 (1.0)

1.4 (1.1)

35.7 (20.4)

15.5 (10.7)

Prolotherapy

6.3 (1.1)

1.4 (1.1)

33.9 (15.5)

11.1 (10)

NRS: Numerical Rating Scale; ODI: Oswestry Disability Index; RCT: randomized controlled trial; SD: standard deviation; VAS: Visual Analog Scale
1 Survey measures of health-related quality of life scored on a scale from 0 to 100, with 100 representing the highest level of functioning in a given category.

The purpose of the study relevance, conduct, and design limitations tables (see Tables 3 and 4) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of theevidence supporting the position statement.

Table 3. Relevance Limitations

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Visser et al (2013)10

4. Patients had additional leg pain with short duration of signs and symptoms

2. Unclear which if any patients received a second injection.

 

4-5. Definition of successful treatment did not utilize standard pain relief threshold cutoff of at least 50%. 

 

Kim et al (2010)11

 

 

 

 

 

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 4. Study Design and Conduct Gaps

Study

Allocationa

Blindingb

Selective Reportingd

Data Completenesse

Powerd

Statisticalf

Visser et al (2013)10

3. Allocation not described. 

1. Trial was single-blinded

1. Not registered. 

 

2. Power not calculated for primary outcome 

3. Confidence intervals and/or p values not reported 

Kim et al (2010)11

3. Allocation not described. 

 

1. Not registered. 

 

 

 

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician..
Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Case Series
Case series studies evaluating corticosteroid injections, described in systematic reviews, have shown variable findings at generally short-term follow-up.9,12,

Section Summary: Therapeutic Corticosteroid Injections
Results from two small trials are insufficient to permit conclusions on the effect of this procedure on health outcomes. Steroid injections were not the most effective treatment in either trial, and the degree of pain relief was limited. Larger trials with rigorous designs, preferably using sham injections, are needed to determine whether the treatment is effective.

Treatment of SIJ Pain: Radiofrequency Ablation
Clinical Context and Therapy Purpose
The purpose of RFA is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of RFA improve the net health outcome in individuals with SIJ pain?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest are individuals with SIJ pain.

Interventions
The therapy being considered is RFA, also known as radiofrequency neurotomy. RFA involves heating a portion of a pain-transmitting nerve to create a heat lesion. The goal of the heat lesion is to functionally denervate the SIJ and prevent transmission of pain signals to the brain. Several variations of RFA are available, including water-cooled, pulsed, and conventional continuous RFA. Water-cooled RFA produces larger lesions than the other two modalities, however, lesion size is also dependent on temperature, needles size, and procedure duration. Lateral branch RFA targets the SIJ nerves.

Comparators
The following therapy is currently being used to treat SIJ pain: conservative therapy.

Outcomes
The general outcomes of interest are symptoms (eg, reductions in pain), functional outcomes, QOL, reductions in medication use, and treatment-related morbidity. Follow-up at 3 and 15 months is of interest to monitor outcomes.

Study Selection Criteria
Methodologically credible studies were selected using the principles outlined in indication 2.

Systematic Reviews
Chen et al (2019) performed a meta-analysis of 5 RCTs comparing RFA to sham or medical treatment in patients with chronic SIJ pain.13, Various RFA procedures were represented, including percutaneous, cooled, and palisade SIJ RF neurotomy. Pain outcomes from all RCTs were pooled for the meta-analysis. Disability outcomes were only available for two studies utilizing cooled RFA. While studies showed no significant heterogeneity for disability outcomes, heterogeneity was high for pain outcomes.

Sun et al (2018) published a meta-analysis of 7 studies that included patients with chronic SIJ pain who received treatment with cooled radiofrequency procedures.14,While overall outcomes were improved after treatment, there was heterogeneity across study designs and patient selection, which limited the strength of the meta-analysis. Also, sample sizes in the selected studies were small.

Aydin et al (2010) published a meta-analysis of RFA for sacroiliac pain.15, Nine studies included reported the primary outcome measure of a reduction of pain of 50% or greater, including a randomized placebo-controlled study, 3 prospective observational studies, and 5 retrospective studies. All studies used an injection of a local anesthetic to determine if RFA was indicated for the patient. Seven studies reported follow-up to three months; six studies reported follow-up to six months. The meta-analysis indicated that at least 50% of patients who received RFA to the SIJ showed a reduction in their pain of 50% or more at 3 and 6 months. The analysis found no evidence of publication bias, but heterogeneity in studies was observed for the six-month follow-up. This meta-analysis included low-quality studies and lacked RCTs. In addition, as reviewers noted, no standards have been established for the specific nerves to ablate or type of technique.

No additional studies were identified in the American Society of Interventional Pain Physicians (2013) evidence review, which concluded that evidence was limited for conventional radiofrequency neurotomy, limited for pulsed radiofrequency neurotomy, and fair for cooled radiofrequency neurotomy.5,

Tables 5 and 6 summarize the characteristics and results of select systematic reviews.

Table 5. Characteristics of Systematic Reviews

Study

Dates

Trials

Participants1

N (Range)

Design

Duration, mo

Chen et al (2019) 

2012-2018 

Patients with chronic SIJ pain treated by various RFA procedures compared to sham or medical treatment 

311 (28-155) 

RCTs 

3-6 

Sun et al (2018)

2008-2017

7

Patients with chronic SIJ pain treated by cooled radiofrequency procedure, followed at least 3 mo

240 (15-190)

4 retrospective observational, 2 RCTs, 1 prospective observational

3-24

SIJ: sacroiliac joint; RCT: randomized controlled trial; RFA: radiofrequency ablation.

Table 6. Results of Systematic Reviews    

Study

NRS Score

VAS Score

ODI Score

GPE Score

Chen et al (2019)13, Various RFA

       

Total N

5 studies1; n=311

See NRS Score1

2 studies; n=79

1 study; n=60

MD (95% CI)

-2.13 (-3.4 to -0.87)

 

-8.91 (-16.44 to -1.38)

0.60 (-0.09 to 1.29)

p

0.001

 

0.020

0.090

I2 (p)

82.3% (NR)

 

44.8% (NR)

NR

Sun et al (2018)14, Cooled RFA

       

Total N

4 studies; n=81

3 studies; n=150

5 studies; n=103

4 studies; n=75

MD (95% CI)

3.81 (3.29 to 4.33)

3.78 (3.31 to 4.23)

18.20 (12.22 to 24.17)

OR=0.01 (0.00 to 0.05)

p

<0.001

<0.001

<0.001

<0.001

I2 (p)

46% (0.13)

41% (0.16)

72% (<0.001)

0% (0.92)

CI: confidence interval; GPE: Global Perceived Effect; MD: mean difference; NR: not reported; NRS: numerical rating scale; ODI: Oswestry Disability Index; OR: odds ratio; RFA: radiofrequency ablation; VAS: visual analog scale.
1 All pain scores (NRS, VAS) utilizing an 11-point scoring system were pooled together for the meta-analysis.

Randomized Controlled Trials
Tables 7 and 8 summarize the characteristics and results of select RCTs.

Table 7. Characteristics of Key RCTs Assessing Radiofrequency Ablation

Study

Countries

Sites

Dates

Participants

Interventions

         

Active

Comparator

Mehta et al (2018)16,

UK

1

2012-2015

Patients with SIJ pain confirmed by diagnostic intra-articular injection; only 17 of 30 enrolled patients were randomized due to results of interim analysis

Multi-probe strip lesion RFA (n=11)

Sham (n=6)

4 patients crossed over to active group after 3-month endpoint

Juch et al (2017)17,

Netherlands

16

2013-2014

Patients with chronic low back pain related to the SIJ

  • RFA + exercise program (n=116)
  • 110 received RFA
  • 81 received Palisade RF treatment
  • 23 received cooled RFA
  • 6 received multi-probe strip lesion RFA
  • Exercise program (n=112)
  • 69 completed program
  • 18 did not complete program
  • 25 with unknown completion

Van Tilburg et al (2016)18,

Netherlands

NR

2012-2014

Patients with SIJ pain

Percutaneous RFA to lateral branch and dorsal root primary ramus (n=30)

Sham(n=30)

Zheng et al (2014)19,

China

1

2010-2012

Patients with ankylosing spondylitis and SIJ pain

PSRN with computed tomography guidance (n=82)

Celecoxib treatment (n=73)

Patel et al (2012; 2016)20,21,

U.S.

NR

2008-2010

Patients with SIJ pain

Lateral branch cooled RFA (n=34)

Sham(n=17)

NR: not reported; PSRN: palisade sacroiliac joint radiofrequency neurotomy; RF: radiofrequency; RFA: radiofrequency ablation; RCT: randomized controlled trial: SIJ: sacroiliac joint.

Table 8. Results of Key RCTs Assessing Radiofrequency Ablation

Study

Pain Outcomes

Functional Outcomes

Treatment Success

Mehta et al (2018)16,

NRS at Baseline (SD)

NRS at Month 3 (SD)

PCS1 at Baseline (SD)

PCS at Month 3 (SD)

Treatment Success

Strip lesion RFA

8.1 (0.8)

3.4 (2.0)

28.4 (7.1)

34.7 (10.8)

NR

Sham

6.5 (2.0)

7.3 (0.8)

28.6 (5.0)

29.6 (5.6)

NR

P-Value

NR

<0.001

NR

0.0645

NR

Juch et al (2017)17,

NRS at Month 3 (95% CI)

NRS at Month 12 (95% CI)

ODI at Month 3 (95% CI)

ODI at Month 12 (95% CI)

At Month 3, n/N (%)

At Month 12, n/N (%)

RFA + exercise program

4.77 (4.31 to 5.24)

4.65 (4.16 to 5.13)

27.72 (24.50 to 30.95)

27.29 (23.89 to 30.69)

43/110 (39.10)

49/102 (48.03)

Exercise program

5.45 (4.94 to 5.95)

4.84 (4.30 to 5.38)

29.09 (25.47 to 2.71)

24.49 (20.74 to 28.23)

19/88 (21.59)

24/76 (31.78)

MD/RR (95% CI)

-0.71 (-1.35 to -0.06)

-0.07 (-0.74 to 0.60)

-4.20 (-8.39 to -0.00)

2.11 (-2.25 to 6.47)

1.87 (1.13 to 2.71)

1.46 (0.92 to 2.02)

P-Value

0.03

0.83

0.05

0.34

0.02

0.10

Van Tilburg et al (2016)18,

Mean NRS at Baseline (SD)

Mean NRS at Month 1 (SD)

Mean GPE at Month 1 (SD)

Mean GPE at Month 3 (SD)

Treatment Success

Percutaneous RFA

7.2 (1.4)

5.4 (1.7)

3.2 (1.1)

3.4 (1.6)

NR

Sham

7.5 (1.2)

5.4 (1.9)

3.3 (1.0)

3.4 (1.5)

NR

P Value

NR

NR

NR

NR

NR

Zheng et al (2014)19,

VAS at Week 12 (95% CI)

VAS at Week 24 (95% CI)

Mean BASFI2 at Baseline (95% CI)

BASFI at Week 24 (95% CI)

Treatment Success

PSRN

2.5 (2.2 to 3.0)

2.8 (2.5 to 3.2)

5.4 (5.0 to 5.8)

3.1 (2.7 to 3.6)

NR

Celecoxib

4.4 (4.0 to 4.9)

5.0 (4.6 to 5.3)

5.3 (4.8 to 5.8)

5.0 (4.5 to 5.5)

NR

MD (95% CI)

-1.9 (-2.4 to -1.4)

-2.2 (-2.6 to -1.6)

NR

-1.9 (-2.5 to -1.2)

NR

P Value

<0.0001

<0.0001

NR

<0.0001

NR

Patel et al (2012; 2016)20,21,

NRS at Baseline (SD)

NRS at Month 3 (SD)

ODI at Baseline (SD)

ODI at Month 9 (SD)

At Month 3, n/N (%)

At Month 6, n/N (%)

Cooled RFA

6.1 (1.3)

-2.4 (2.7)

37 (14)

-11 (17)

16/34 (47)

13/34 (38)

Sham

5.8 (1.3)

-0.8 (2.4)

35 (10)

2 (6)

2/17 (12)

7/16 (44)3

P Value

0.370

0.035

0.639

0.011

0.015

NR

BASFI: Bath Ankylosing Spondylitis Functional Index; CI; confidence interval; GPE: Global Perceived Effect;MD: mean difference; NR: not reported; NRS; Numeric Rating Scale; ODI: Oswestry Disability Index; PCS: Physical Component Score; RCT: randomized control trial; RFA: radiofrequency ablation; RR: relative risk; SD: standard deviation; VAS; Visual Analog Scale.
1 Higher scores on the SF-12 Physical Component Score (PCS) indicate improved outcomes.
2 The Bath Ankylosing Spondylitis Functional Index (BASFI) measures overall functional outcomes on a scale from 0-10 with 0 indicating best possible functioning.
3 Patients assigned to the sham group were allowed to crossover to active treatment after the 3-month study endpoint.

Mehta et al (2019) published results from a double-blind, randomized, sham-controlled trial assessing the efficacy of radiofrequency neurotomy with a strip-lesioning device in patients with chronic SIJ pain. Seventeen of 30 enrolled patients were randomized to active (n=11) or sham (n=6) treatment. Recruitment was terminated after an interim analysis indicated a statistically significant difference in the pain outcome between groups. After the three-month study endpoint, patients receiving sham treatment were allowed to crossover. While a statistically significant reduction in pain scores was reported at three months, there was no significant difference in functional outcome as measured by the Physical Component Score at three months. Due to the crossover design, it is difficult to gauge long term outcomes and durability of the treatment.

Juch et al (2017) reported a nonblinded multicenter RCT of radiofrequency denervation in 228 of 2498 patients with suspected sacroiliac pain who were asked to participate in the trial.20, Patient selection criteria included body mass index (<35 kg/m2), age (<70 years old), and pain reduction of at least 50% within 30 to 90 minutes of receiving a diagnostic sacroiliac block (n=228). An additional 202 patients had a negative diagnostic sacroiliac block; 1666 patients declined to participate in the trial. Patients meeting criteria were randomized to exercise plus radiofrequency denervation (n=116) or an exercise program alone (n=112) and were followed for a year. The RFA group had a modest improvement for the primary outcome at 3 months (-0.71; 95% CI, -1.35 to -0.06), but the control group improved over time and there were no statistically significant differences between the groups for pain intensity score (p=0.09) or in the number of patients who had more than a 30% reduction in pain intensity (p=0.48) at 12 months. Limitations included the use of several techniques to achieve radiofrequency denervation, self-selection, lack of blinding, and a high dropout rate (31%) in the control group.

Van Tilburg et al (2016) reported a sham-controlled randomized trial of percutaneous RFA in 60 patients with SIJ pain.21, Patients selected had clinically suspected SIJ pain and a decrease of two or more points on a 10-point pain scale with a diagnostic sacroiliac block. At 3-month follow-up, there was no statistically significant difference in pain level over time between groups (group by period interaction, p=0.56). Both groups improved over time (»2 points out of 10; p-value for time, p<0.001). In their discussion, trialists mentioned the criteria and method used for diagnosing SIJ pain might have resulted in the selection of some patients without SIJ pain.

Zheng et al (2014) reported on an RCT of palisade sacroiliac RFA in 155 patients with ankylosing spondylitis.19, Palisade RFA uses a row of radiofrequency cannulae perpendicular to the dorsal sacrum. Inclusion criteria were ages 18 to 75 years; diagnosis of ankylosing spondylitis; chronic low back pain for at least 3 months; axial pain below L5; no peripheral involvement; pain aggravation on manual pressing of the SIJ area; and at least 50% pain relief following fluoroscopically guided anesthetic injection into the joint. Patients who met the inclusion criteria were randomized to palisade RFA or celecoxib. Blinded evaluation to 24 weeks found that RFA (2.8) resulted in lower global VAS scores than celecoxib (5.0; p<0.001) as well as improved scores for secondary outcome measures. This study lacked a sham control.

Patel et al (2012) reported a randomized, double-blind, placebo-controlled trial of lateral branch neurotomy with a cooled radiofrequency probe.18, Twelve-month follow-up was reported in 2016.17, Fifty-one patients who had a positive response to two lateral branch blocks were randomized 2:1 to lateral branch radiofrequency or to sham. At a 3-month follow-up, significant improvements were observed in pain levels (-2.4 vs -0.8), physical function (14 vs 3), disability (-11 vs 2), and QOL (0.09 vs 0.02) for radiofrequency treatment compared with controls (all respectively). With treatment success defined as a 50% or greater reduction in numeric rating scale score, 47% of radiofrequency-treated patients and 12% of sham-treated patients achieved treatment success. The treatment response was durable to 12 months in the 25 of 34 patients who completed all follow-up visits.17, Of the 9 patients who terminated study participation, 4 (12%) of 34 were considered treatment failures.

Tables 9 and 10 display notable relevance, design, and conduct limitations identified in each study.

Table 9. Relevance Limitations

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Mehta et al (2019)16,

4. Female subjects of childbearing age were required to use a hormonal or implantable contraceptive agent in order to participate in the study.     1. Disability outcomes were not reported.  

Juch et al (2017)17,

4. Patients older than 70 years were excluded.

 

2. Not a sham control.

   

Van Tilburg et al (2016)18,

 

 

 

   

Zheng et al (2014)19,

. Patients were required to have a diagnosis of ankylosing spondylitis in addition to chronic low back pain related to the sacroiliac joint. 

 

2. Not a sham control 

   

Patel et al (2012)20,21, 

 

 

 

   

The studylimitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not established and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 10. Study Design and Conduct Limitations

Study

Allocationa

Blindingb

Selective Reportingc

Data Completenessd

Powere

Statisticalf

Mehta et al (2019)16,

     

3. 66.6% of sham group patients crossed over to treatment group at 3 mo

Other related:

  • Small study size due to interim analysis
 

Juch et al (2017)17,

 

1-2. Study was not blinded.

       

Van Tilburg et al (2016)18,

     

3. 63.3% of sham group patients crossed over to treatment group

   

Zheng et al (2014)19, 

     

 

   

Patel et al (2012)20,21, 

     

3 Patients in sham group could cross over at 3 mon 

   

The studylimitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: RFA
The randomized trials of RFA have methodologic limitations; moreover, there is limited data on the duration of the treatment effect. Heterogeneity of RFA treatment techniques precludes generalizing results across different studies.

Treatment of SIJ Pain: SIJ Fusion/Fixation with a Triangular Implant System
Clinical Context and Therapy Purpose
The purpose of SIJ fixation/fusion with a triangular implant is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of SIJ fixation/fusion with a triangular implantimprove the net health outcome in individuals with SIJ pain?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest are individuals with SIJ pain.

Interventions
The therapy being considered is SIJ fixation/fusion with a triangular implant.

Comparators
The following therapy is currently being used to treat SIJ pain: conservative therapy.

Outcomes
The general outcomes of interest are symptoms (eg, reductions in pain), functional outcomes, QOL, reductions in medication use, and treatment-related morbidity. Follow-up from oneto one years is of interest to monitor outcomes.

Study Selection Criteria
Methodologically credible studies were selected using the principles outlined in indication 2.

Randomized Controlled Trials
INSITE
Whang et al (2015) reported an industry-sponsored nonblinded RCT, Investigation of Sacroiliac Fusion Treatment (INSITE) of the iFuse Implant System in 148 patients.22, The 12-month follow-up to this RCT was reported by Polly et al (2015),23, and a 2-year follow-up was reported by Polly et al (2016).24, However, by 12 months, almost all patients in the control group had crossed over to SIJ fusion, precluding a comparison between groups. Trial inclusion was based on a determination of the SIJ as a pain generator from a combination of a history of SIJ-localized pain, positive provocative testing on at least 3 of 5 established physical tests, and at least a 50% decrease in SIJ pain after image-guided local anesthetic injection into the SIJ. Trial characteristics are summarized in Table 11. The duration of pain before enrollment averaged 6.4 years (range, 0.47-40.7 years). A large proportion of subjects (37%) had previously undergone lumbar fusion, SIJ steroid injections (86%), and RFA (16%).

Patients were randomized 2:1 to minimally invasive SIJ fusion (n=102) or to nonsurgical management (n=46). Nonsurgical management included a stepwise progression of nonsurgical treatments, depending on individual patient choice. During follow-up, control patients received physical therapy (97.8%), intra-articular steroid injections (73.9%), and RFA of sacral nerve roots (45.7%). The primary outcome measure was the 6-month success rate, defined as the proportion of treated subjects with a 20-mm improvement in SIJ pain in the absence of severe device-related or neurologic adverse events or surgical revision. Patients in the control arm could crossover to surgery after six months. Baseline scores indicated that the patients were severely disabled, with VAS pain scores averaging 82.3 out of 100, and ODI scores averaging 61.9 out of 100 (0=no disability, 100=maximum disability).

Results from the INSITE trial are shown in Table 12. At 6 months, success rates were 23.9% in the control group vs 81.4% in the surgical group (posterior probability of superiority >0.999). A clinically important (≥15-point) improvement in ODI score was found in 27.3% of controls compared with 75.0% of fusion patients. Measures of QOL (36-Item Short-Form Health Survey, EuroQol-5D) also improved to a greater extent in the surgery group. Of the 44 nonsurgical management patients still participating at 6 months, 35 (79.5%) crossed over to fusion. Compared with baseline, opioid use at 6 months decreased from 67.6% to 58% in the surgery group and increased from 63% to 70.5% in the control group (p=0.082). At 12 months, opioid use was similar between groups (55% vs 52%, p=0.61).

Polly et al (2016) reported 2-year outcomes from the SIJ fusion arm of this RCT (see Table 13).24, Of 102 subjects originally assigned to SIJ fusion and treated, 89 (87%) were evaluated at 2 years. In this report, clinical outcomes were based on the amount of improvement in SIJ pain and in ODI scores. The improvement was defined as a change of 20 points in the SIJ pain score and 15 points in the ODI score. Substantial improvement was defined as a change of 25 points in SIJ pain score-or an SIJ pain score of 35 or less-and an improvement of 18.8 points in the ODI score. At 24 months, 83.1% had improvements in SIJ pain score, and 68.2% had improvements in ODI scores. By 24 months, the proportion taking opioids was reduced from 68.6% at baseline to 48.3%.

Three-year follow-up results of the INSITE and Sacroiliac Joint Fusion with iFuse Implant System trials were published by Darr et al (2018).25, Of 103 patients with SIJ dysfunction who were treated with minimally invasive SIJ fusion with triangular titanium implants, 60 (72.3%) patients reported an improvement in ODI scores of at least 15 points from baseline to 3 years. The mean ODI score decreased from 56 to 28 for the same timeframe, an improvement of 28 points (p<0.001); similarly, the mean SIJ pain score decreased to 26.2, reflecting a decrease of 55 points (p<0.001). Over 3 years of follow-up, 168 adverse events were reported in 75 patients, although only 22 of these events involved the pelvis. The study was limited by its lack of long-term data from a control group not receiving surgical treatment.

iMIA
In 2016 and 2017, the iFuse Implant System Minimally Invasive Arthrodesis (iMIA) study group reported another industry-sponsored multicenter RCT of the iFuse Implant System in 103 patients.26,27, Selection criteria were similar to those of the trial by Whang et al (2015), including at least a 50% pain reduction on SIJ block. The mean pain duration was 4.5 years, and about half of the patients were not working due to lower back pain. Additionally, 33% of patients had undergone prior lumbar fusion. Nonsurgical management included physical therapy and exercises at least twice per week; interventional procedures (eg, steroid injections, RFA) were not allowed. The primary outcome was change in the VAS pain score at six months.

All patients assigned to iFuse underwent the procedure, and follow-up at 6 months was available for 49 of 51 patients in the control group and for all 52 patients in the iFuse group. Six-month results as reported by Sturesson et al (2016) are shown in Table 12.26, At 6 months, VAS pain scores improved by 43.3 points in the iFuse group and by 5.7 points in the control group (p<0.001). ODI scores improved by 25.5 points in the iFuse group and by 5.8 points in the control group (p<0.001, between groups). An improvement in lower back pain by at least 20 VAS points (a minimal clinically important difference) was achieved in 78.8% of the SIJ fusion group vs 22.4% of controls; p<0.001). QOL outcomes showed a greater improvement in the iFuse group than in the control group. Changes in pain medication use were not reported. Patients in the conservative management group were allowed to cross over to SIJ fusion at six months.

Twelve-month results from the iMIA trial were reported by Dengler et al (2017) (see Table 13).28, Twenty-one patients in the conservative management group had little or no improvement in symptoms and crossed over to SIJ fusion after the six-month visit. Fourteen (56%) of the 25 patients who remained in the conservative management group had at least a 20-point improvement in VAS back pain score (22.4% of patients assigned to conservative management). At 12 months, low back pain had improved by 42 points (standard deviation [SD], 27.0) on a 100-point VAS in the SIJ fusion group compared with 14 points (SD=33.4) in the conservative management group (p<0.001). Mean ODI scores improved by 25 points in the SIJ fusion group compared with 8.7 points in controls (p<0.001).

Table 11. Summary of Key RCT Characteristics

Study; Trial

Countries

Sites

Dates

Participants

Interventions

         

Active

Comparator

Whang et al (2015)22,; INSITE

U.S.

19

2013-2014

Patients 21-70 y with confirmed diagnosis of unilateral or bilateral SIJ dysfunction due to degenerative sacroiliitis and/or SIJ disruption

102 randomized to SIJ fusion

46 randomized to nonsurgical management

Sturesson et al (2017)26,; iMIA

EU (Belgium, Germany, Italy, Sweden)

9

2013-2015

Patients 21-70 y with LBP for >6 mo and diagnosed with SIJ as primary pain generatora

52 randomized to SIJ fusion

51 randomized to conservative management

LBP: low back pain; RCT: randomized controlled trial; SIJ: sacroiliac joint.
a The 3 criteria for diagnosis of SIJ pain were as follows: pain was present or near the posterior superior iliac spine; there were at least 3 positive findings on 5 provocative tests; at least a 50% pain reduction on fluoroscopically guided injection of local anesthetic into the joint.

Table 12. Summary of Six-Month iFuse Results From INSITE and iMIA

Results

VAS Score

Success End Point

ODI Score

SF-36 PCS Score

EQ-5D TTO Index

 

Ctl

iFuse

Ctl

iFuse

Ctl

iFuse

Ctl

iFuse

Ctl

iFuse

INSITE22,

                 

Baseline

82.2

82.3

   

61.1

62.2

30.8

30.2

0.47

0.44

Follow-up

70.4

29.8

23.9%

81.4%a

56.4

31.9

32.0

42.8

0.52

0.72

Change

-12.1

-52.6a

   

-4.9

-30.3a

1.2

12.7

0.05

0.29

iMIA26,

                 

Baseline

73.0

77.7

               

Follow-up

67.8

34.4

               

Change

-5.7

-43.3

   

-5.8

-25.5

   

0.11

0.37

Adapted from Whang et al (2015)22, and Sturesson et al (2015).26,
The success endpoint was defined as a reduction in VAS pain score of ≥20, absence of device-related events, absence of neurologic worsening, and absence of surgical intervention.
Ctl: control; EQ-5D TTO Index: EuroQoL Time Tradeoff Index; ODI: Oswestry Disability Index; SF-36 PCS: 36-Item Short-Form Health Survey Physical Component Summary; VAS: visual analog scale.
a p<0.001.

Table 13. Extended Follow-Up From the INSITE and iMIA Trial 

Outcome Measures

Baseline (SD)

6 Months (SD)

12 Months (SD)

24 Months (SD)

INSITE22,

       

Sacroiliac joint fusion pain score

82.3

29.8

 

26.7

Percent ≥20-point improvement pain

     

83.1%

Sacroiliac joint fusion ODI score

57.2

31.9

 

28.7

% ≥15-point improvement ODI

     

68.2%

iMIA26,28,

       

Low back pain

       

Conservative management 

73.0 (13.8) 67.8 (20.3) 58.9 (28.2)  

Sacroiliac joint fusion 

77.7 (11.3) 34.4 (23.9) 35.2 (25.5)  

Leg pain 

       

Conservative management 

47.1 (31.1) 46.5 (31.4) 41.7 (32.4)  

Sacroiliac joint fusion 

52.7 (31.5) 22.6 (25.1) 24.0 (27.8)  

ODI 

       

Conservative management 

55.6 (13.7) 50.2 (17.2) 46.9 (20.8)  

Sacroiliac joint fusion 

57.5 (14.4) 32.0 (18.4) 32.1 (19.9)  

Adapted from Dengler et al (2017).28,
ODI: Oswestry Disability Index; SD: standard deviation.

Tables 14 and 15 display notable limitations identified in each study.

Table 14. Relevance Limitations

Study; Trial

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Whang et al (2015)22,; INSITE

 

 

 

 

 

Sturesson et al (2017)26,; iMIA

1. Patients with other contributory sources of LBP might have been enrolled with SIJ-caused LBP patients

 

 

 

 

The studylimitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
LBP: low back pain; SIJ: sacroiliac joint.
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 15. Study Design and Conduct Limitations

Study; Trial

Allocationa

Blindingb

Selective Reportingc

Data Completenessd

Powere

Statisticalf

Whang et al (2015)22,; INSITE 

 

 

 

 

 

 

Sturesson et al (2017)26,; iMIA 

 

1. Intervention was unblinded 

 

 

 

 

The studylimitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
dData Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Subsection Summary: Randomized Controlled Trials
Two RCTs have reported outcomes past six months, after which crossover was allowed. Both studies reported significantly greater reductions in VAS pain scores and ODI scores in SIJ fusion patients than in control groups. The reductions in pain and disability observed in the SIJ fusion group at six months were maintained out to one year compared with controls who had not crossed over. The RCTs were nonblinded without a placebo or an active control group. However, the pain has a significant subjective and psychologic component. Cognitive-behavioral techniques to address pain were specifically excluded from the types of treatment that control subjects could obtain. Thus, as relates to trial design, an independent assessment of pain outcomes would have been preferable.

Nonrandomized Studies
Prospective cohort studies with good follow-up rates are more likely to provide valid estimates of outcomes. Principal results of the studies at 2- to 3-year follow-up are shown in Table 16.

Results from a cohort of 172 patients undergoing SIJ fusion reported to 2 years were published by Duhon et al (2016).29,30, Patients were formally enrolled in a single-arm trial (NCT01640353) with planned follow-up for 24 months. Success was defined as a reduction of pain score of 20-mm on a 100-mm VAS, absence of device-related adverse events, absence of neurologic worsening, and absence of surgical reintervention. Enrolled patients had a mean VAS pain score of 79.8, a mean ODI score of 55.2, and a mean pain duration of 5.1 years. At 6 months, 136 (80.5%) of 169 patients met the success endpoint, which met the prespecified Bayesian probability of success rate. Mean VAS pain scores were 30.0 at 6 months and 30.4 at 12 months. Mean ODI scores were 32.5 at 6 months and 31.4 at 12 months. At 2 years, 149 (87%) of 172 patients were available for follow-up. The VAS pain score at 2 years was 26.0, and the ODI score was 30.9. Thus, one-year outcomes were maintained at two years. Other outcomes (eg, QOL scores) showed similar maintenance or slight improvement compared with one-year outcomes. Use of opioid analgesics decreased from 76.2% at baseline to 55% at 2 years. Over the two-year follow-up, eight (4.7%) patients required revision surgery.

Table 16. Two- to Three-Year Outcomes of the iFuse Implant in Cohorts and Case Series

Studies and Outcomes

Mean Baseline Value

Mean 2- to 3-Year Value

Difference or % Achieving Outcome

Follow-Up Rate

Duhon et al (2016)29,30,

       

Pain score (range, 0-100)

79.8

26.0

53.3

86.6% (149/172)

Oswestry Disability Index score

55.2

30.9

24.5

 

SF-36 score

31.7

40.7

8.9

 

EQ-5D TTO score

0.43

0.71

0.27

 

All differences between baseline and 2- to 3-year values were statistically significant.
EQ-5D TTO Index: EuroQoL Time Tradeoff Index; SF-36: 36-Item Short-Form Health Survey.

Nonrandomized Comparative Studies
Two retrospective nonrandomized comparative studies have been published. Vanaclocha et al (2018) found greater pain relief with SIJ fusion than with conservative management or SIJ denervation.31, Spain and Holt (2017) reported a retrospective review of surgical revision rates following SIJ fixation with either surgical screws or the iFuse triangular implant.32, Revision rates were lower with the iFuse device than observed with surgical screws.

Subsection Summary: Nonrandomized Studies
In general, cohort studies and case series have shown improvements in VAS pain scores and other outcomes measures consistent in magnitude to the RCTs. The subset of studies with good (>85%) follow-up rates generally showed that short-term outcomes were maintained. Two studies of reasonable sample size with good follow-up showed results maintained to two years.30,33, One study with small sample size and good follow-up showed results maintained to five years.31, Improved health outcomes are also supported by retrospective studies that compare SIJ fusion/fixation using a triangular implant with other treatments for SIJ pain.31,32,These results are consistent with the medium-term durability of the treatment. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and the cumulative revision rate at 4 years of 3.54%.34,

Section Summary: SIJ Fusion/Fixation With a Triangular Implant
The evidence on SIJ fusion/fixation with a triangular implant includes 2 nonblinded RCTs of minimally invasive fusion and 2 case series with more than 85% follow-up at 2 to 3 years. Both RCTs reported superior short-term results for fusion, however, a preferable design for assessing pain outcomes would be an independent blinded assessment of outcomes or, when feasible, a sham-controlled trial. Longer-term follow-up from these RCTs has indicated that the results obtained at six months persist to two years. An additional cohort study and case series with sample sizes ranging from 45 to 149 patients and low dropout rates (<15%) also showed reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to five years. The cohort studies and case series are consistent with the durability of treatment benefit. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and the cumulative revision rate at 4 years of 3.54%.

Treatment of SIJ Pain: SIJ Fixation/Fusion with a Cylindrical Threaded Implant
Clinical Context and Therapy Purpose
The purpose of SIJ fixation/fusion with a cylindrical threaded implant is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of SIJ fixation/fusion with a cylindrical threaded implant improve the net health outcome in individuals with SIJ pain?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest are individuals with SIJ pain.

Interventions
The therapy being considered is SIJ fixation/fusion with a cylindrical threaded implant.

Comparators
The following therapy is currently being used to treat SIJ pain: conservative therapy.

Outcomes
The general outcomes of interest are symptoms (eg, reductions in pain), functional outcomes, QOL, reductions in medication use, and treatment-related morbidity. Follow-up from oneto five years is of interest to monitor outcomes.

Study Selection Criteria
Methodologically credible studies were selected using the principles outlined in indication 2.

Systematic Reviews
Tran et al (2019) published a systematic review comparing the effectiveness of minimally invasive joint fusion (ie, utilizing the iFuse device) compared to screw-type surgeries.35, A total of twenty studies was pooled to calculate a standardized mean difference across pain, disability, and global/quality-of-life outcomes, including 14 studies evaluation the iFuse system and 7 studies evaluated cylindrical, threaded implants. Studies evaluating cylindrical, threaded implants consisted of case series and cohort studies. Patients receiving these implants experienced significantly worse pain outcomes (p=0.03) compared to patients receiving iFuse, with a standardized mean difference of 1.28 (95% CI: 0.47 to 2.09) and 2.04 (95% CI: 1.76 to 2.33), respectively. A statistically significant difference in disability scores was reported between screw-type and iFuse implant groups (0.26 [95% CI: -1.90 to 2.41] vs 1.68 [95% CI: 1.43 to 1.94]; p=0.01), with improved outcomes in the iFuse population. For global/quality-of-life outcomes, a statistically significant difference in scores was reported between screw-type and iFuse implants groups (0.60 [95% CI: 0.33 to 0.88] vs 0.99 [95% CI: 0.75 to 1.24]; p=0.04), with improved outcomes in the iFuse population.

Prospective Studies
Rappoport et al (2017) reported on an industry-sponsored prospective study of SIJ fusion with a cylindrical threaded implant (SI-LOK).36, The study included 32 patients using a diagnosis of SIJ dysfunction who had failed nonoperative treatment, including medication, physical therapy, and therapeutic injections. A diagnostic injection was performed to confirm the source of pain to the SIJ. The procedure included drilling to prepare for screw insertion and implantation of 3 screws, at least one of which was slotted. The slotted screws were packed with an autogenous bone graft from the drill reamings. Pain and disability scores were reduced following device implantation (see Table 17), and revisions within the first 12 months of the study were low (n=2). Follow-up will continue through two years.

Araghi et al (2017) published interim results from an industry-sponsored prospective cohort study evaluating pain and ODI outcomes for patients treated for SIJ pain with the SImmetry system.37, For the 50 patients enrolled at the time of publication, the mean VAS score had decreased from 76.2 at baseline to 35.1 at 6 months after the procedure (p<0.001), with 36 (72%) patients achieving minimal clinically important difference (at least a 20-point reduction). The mean ODI score likewise showed significant improvement from baseline to 6 months, decreasing from 55.5 to 35.3 (p<0.001). Over half of the cohort (56% [n=28]) achieved the minimal clinically important difference (15-point reduction) on the ODI. Prior to surgery, 66% (n=33) of the cohort were on opioids, decreasing to 30% (n=15) at the 6-month follow-up (p<0.001). QOL was assessed with the EQ-5D time trade-off index: at baseline, the mean EQ-5D was 0.51, decreasing to 0.69 after 6 months (p<0.001). Likewise, improvements in the Physical and Mental Components Summary scores of the 36-Item Short-Form Health Survey were significantly improved at 6 months, compared with baseline. The strength of findings was limited by the small sample size and short follow-up; without full enrollment of 250 patients, the trial is underpowered to detect contributing factors to fusion and pain relief. Also, the trial does not have a control group. Follow-up data will be published at one and two years.

Case Series
Cross et al (2018) published a case series of 19 patients from 3 centers who underwent minimally invasive SIJ fusion with decortication, placement of the bone graft, and fixation with threaded implants.38, At 12 months, bridging bone across the SIJ was observed in 79% (n=15) of patients, increasing to 94% (n=17 of 18 patients with data available) at 24 months. At 24 months postprocedure, 88% (n=15) had fusion within the decorticated area, and the same percentage of patients (88% [n=15]) had solid fusion. While the study was not powered to detect associations between radiographic fusion and clinical outcomes, the authors reported a significant change in the mean numeric rating scale score for pain, from preprocedure to 24-month follow-up: patients showed an average 73% reduction in low back pain (7.9/10 decreased to 2.1/10, p<0.01; effect size, -2.9). The industry-sponsored study had a small sample size, but provided follow-up data at two years after SIJ fusion with a threaded implant, indicating a need for larger comparative studies to confirm the favorable radiographic fusion results suggested by the study.

Table 17. Pain and Disability Scores After Implantation With a Cylindrical Threaded Implant

Outcome Measures

Baseline

3 Months (SD)

6 Months (SD)

12 Months (SD)

p

Low back pain

55.8 (26.7)

28.5 (21.6)

31.6 (26.9)

32.7 (27.4)

<0.01

Left leg pain

40.6 (29.5)

19.5 (22.9)

16.4 (25.6)

12.5 (23.3)

<0.01

Right leg pain

40.0 (34.1)

18.1 (26.3)

20.6 (25.4)

14.4 (21.1)

<0.05

Oswestry Disability Index

55.6 (16.1)

33.3 (16.8)

33.0 (16.8)

34.6 (19.4)

<0.01

Adapted from Rappoport et al (2017).36,
SD: standard deviation.

Section Summary: SIJ Fixation/FusionWith Cylindrical Threaded Implant
There is limited evidence on the fusion of the SIJ with devices other than the triangular implant. One-year results from a prospective cohort of 32 patients who received a cylindrical slotted implant showed reductions in pain and disability similar to results obtained for the triangular implant. However, there is uncertainty in the health benefit of SIJ fusion/fixation with this implant design. Therefore, controlled studies with a larger number of patients and longer follow-up are needed to evaluate this device.

Summary of Evidence
Diagnostic
For individuals who have suspected SIJ pain who receive a diagnostic sacroiliac block, the evidence includes systematic reviews. The relevant outcomes are test validity, symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Current evidence is conflicting on the diagnostic utility of SIJ blocks. The evidence is insufficient to determine the effects of the technology on health outcomes.

Therapeutic
For individuals who have SIJ pain who receive therapeutic corticosteroid injections, the evidence includes small RCTs and case series. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. In general, the literature on injection therapy of joints in the back is of poor quality. Results from two small RCTs showed that therapeutic SIJ steroid injections were not as effective as other active treatments. Larger trials, preferably using sham injections, are needed to determine the degree of benefit of corticosteroid injections over placebo. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have SIJ pain who receive RFA, the evidence includes four small RCTs using different radiofrequency applications and case series. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. For RFA with a cooled probe, the two small RCTs reported short-term benefits, but these are insufficient to determine the overall effect on health outcomes. The RCT on palisade RFA of the SIJ did not include a sham control. Another sham-controlled randomized trial showed no benefit from RFA. Further high-quality controlled trials are needed to compare this procedure in defined populations with sham control and alternative treatments. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have SIJ pain who receive SIJ fixation/fusion with a triangular implant, the evidence includes 2 nonblinded RCTs of minimally invasive fusion and 2 case series with more than 85% follow-up at 2 to 3 years. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Both RCTs reported superior short-term results for fusion, however, a preferable design for assessing pain outcomes would be independent, blinded assessment of outcomes or, when feasible, a sham-controlled trial. Longer-term follow-up from these RCTs has indicated that the results obtained at six months persist to two years. An additional cohort study and case series, with sample sizes ranging from 45 to 149 patients and low dropout rates (<15%), have also shown reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to five years. The cohort studies and case series are consistent with the durability of treatment benefit. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and the cumulative revision rate at 4 years of 3.54%. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have SIJ pain who receive SIJ fusion/fixation with a cylindrical threaded implant, the evidence includes a prospective cohort. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The prospective cohort study will follow patients for two years following implantation of slotted screws filled with autologous bone. Results at one year are consistent with findings from the studies using a triangular implant. However, longer follow-up and controlled trials are needed to evaluate this type of implant. The evidence is insufficient to determine the effects of the technology on health outcomes.

Clincial Input
Objective
Clinical input is sought to help determine the appropriate use in the clinical practice of sacroiliac joint fusion for patients with sacroiliac joint pain.

Respondents
Clinical input was provided by the following specialty societies and physician members identified by a specialty society or health system:

  • American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNSAmerican Pain Society (APS)
  • American Society of Regional Anesthesia and Pain Medicine (ASRA)a
  • International Society for the Advancement of Spine Surgery (ISASS)b
  • North American Spine Society/American Academy of Orthopaedic Surgeons (NASS/AAOS)
  • Neil Malhotra, MD, Assistant Professor of Neurosurgery, Perelman School of Medicine, University of Pennsylvania (identified by Hospital of the University of Pennsylvania)
  • William Welch, MD, Vice Chair (Clinical) and Professor, Department of Neurosurgery, Perelman School of Medicine, University of Pennsylvania (identified by Hospital of the University of Pennsylvania)
  • Zachary Gordon, MD, Assistant Professor, Department of Orthopaedics, Case Western Reserve University, identified by University Hospitals Cleveland Medical Center
  • A. Alex Jahangir, MD, MMHC, Medical Director and Associate Professor of Orthopaedic Surgery, identified by Vanderbilt University Medical Center
  • Anonymous, MD, Assistant Professor of Orthopaedics and Rehabilitation; identified by Oregon Health and Science University.

a Indicates that information was not provided regarding conflicts of interest related to the topic where clinical input is being sought.
b Indicates that conflicts of interest related to the topic where clinical input is being sought were identified by this respondent (see Appendix 1).

Clinical input provided by the specialty society at an aggregate level is attributed to the specialty society. Clinical input provided by a physician member designated by the specialty society or health system is attributed to the individual physician and is not a statement from the specialty society or health system. Specialty society and physician respondents participating in the Evidence Street® clinical input process provide a review, input, and feedback on topics being evaluated by Evidence Street. However, participation in the clinical input process by a special society and/or physician member designated by the specialty society or health system does not imply an endorsement or explicit agreement with the Evidence Opinion published by BCBSA or any Blue Plan.

Clinical Input Responses

Figure 1:

* Indicates that information was not provided regarding conflicts of interest related to the topic where clinical input is being sought.

** Indicates that conflicts of interest related to the topic where clinical input is being sought were identified by this respondent (see Appendix).

Additional Comments

  • "The evaluation of a patient for possible sacroiliac (SI) joint pain involves careful attention to a patient’s history and physical examination. When a patient’s symptoms and signs arouse sufficient clinical suspicion, additional tests are then required to confirm the diagnosis of SI joint dysfunction." (AANS/CNS)
  • "Proper SIJ pain diagnosis is key to appropriate patient management. There is an accepted diagnostic algorithm for SIJ pain that combines medical history, physical examination and confirmatory diagnostic SIJ block." (ISASS)
  • "The North American Spine Society’s coverage recommendations on SI joint fusion provides evidence-based criteria for diagnosing SI joint pain and selection criteria for surgical intervention." (NASS/AAOS)
  • "The North American Spine Society Criteria are the most respected and generally used criteria. Most patients with SI joint pain will respond to the conservative therapies listed. However, one criteria that I think should be added is a reduction in opioid use prior to the fusion." (APS)
  • "SI fusion is currently acceptable therapy in patients in whom significant response is noted with injection. SI joint fusion as part of the inferior portion of extensive thoracolumbar fusion (IE SI joint and pelvis) is an accepted approach. Increasing literature on the topic will enhance the knowledge base on this topic." (Neil Malhotra, MD identified by Hospital of the University of Pennsylvania)
  • "The only generally accepted objective criteria for the diagnosis of sacroiliac joint pain is response to image-guided sacroiliac injections. Patients who do not respond to the injections generally do not improve with directed therapies. Patients who do improve with the injections will usually respond to fusion therapies.” (William Welch, MD identified by Hospital of the University of Pennsylvania)
  • "Although criteria for the diagnosis of SI joint dysfunction is fairly well described, there is significant variability from study to study regarding the application of the diagnostic criteria. It is difficult to assess the efficacy of a treatment such as SI joint fusion when there is not a clearly defined and consistent manner of diagnosis from study to study. The vast majority of literature regarding outcomes following SI joint fusion surgery are low-quality retrospective studies, or small sample size prospective studies with limited follow-up." (Zachary Gordon, MD identified by University Hospitals Cleveland Medical Center)
  • "While the evidence is low, I agree with the NASS recommendations as outlined in their report particularly focusing on the fact that a patient has undergone and failed a minimum 6 months of intensive nonoperative treatments, the patient has a complaint and physical exam consistent with SIJ pain, imaging of the SI joint that excludes the presence of destructive lesions, at least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions and finally a successful trial of at least one therapeutic intra-articular SIJ injection with a corticosteroid.” (A. Alex Jahangir, MD identified by Vanderbilt University Medical Center)

See Appendix 1 and 2 for details.

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2017 Input
In response to requests, clinical input focused on sacroiliac joint (SIJ) fusion was received from 10 respondents, including 5 specialty society-level responses from 7 specialty societies (2 were joint society responses) and 5 physician-level responses from 4 academic centers while this policy was under review in 2017.

Based on the evidence and independent clinical input, the clinical input supports that the following indication provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice:

  • Use of fusion/stabilization of the SIJ using percutaneous and minimally invasive techniques for carefully selected patients as outlined in statements from the North American Spine Society.

2015 Input
In response to requests, focused input on SIJ fusion was received from 5 physician specialty societies and 3 academic medical centers while this policy was under review in 2015. Most reviewers considered SIJ fusion to be investigational.

2014 Input
In response to requests, input was received from 4 physician specialty societies and 4 academic medical centers (5 responses) while this policy was under review in 2014. Input was mixed on the use of arthrography, radiofrequency ablation, and fusion of the SIJ. Most reviewers considered injection for diagnostic purposes to be medically necessary when using controlled blocks with at least 75% pain relief, and for injection of corticosteroids for treatment purposes. Treatment with prolotherapy, periarticular corticosteroid, and periarticular botulinum toxin were considered investigational by most reviewers.

2010 Input

In response to requests, input was received from 4 physician specialty societies (6 responses) and 3 academic medical centers (5 responses) while this policy was under review in 2010. Input was mixed. There was general agreement that the evidence for SIJ injections is limited, although most reviewers considered sacroiliac injections to be the best available approach for diagnosis and treatment in defined situations.

Practice Guidelines and Position Statements
North American Spine Society
The NASS (2015) published coverage recommendations for percutaneous SIJfusion.39,The NASS indicated that there was relatively moderate evidence. In the absence of high-level data, NASS policies reflect the multidisciplinary experience and expertise of the committee members in order to present reasonable standard practice indications in the U. S. The NASS recommended coverage when all of the following criteria are met:

  1. "(Patients) have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ, and hip including a home exercise program.
  2. Patient’s report of typically unilateral pain that is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain.
  3. A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin’s point, ie, at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (eg, greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist.
  4. Positive response to a cluster of 3 provocative tests (eg, thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test). Note that the thrust test is not recommended in pregnant patients or those with connectivetissue disorders.
  5. Absence of generalized pain behavior (eg, somatoform disorder) or generalized pain disorders (eg, fibromyalgia).
  6. Diagnostic imaging studies that include ALL of the following:
    1. Imaging (plain radiographs and a CT (computed tomography) or MRI [magnetic resonance imaging]) of the SI joint that excludes the presence of destructive lesions (eg, tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion.
    2. Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology.
    3. Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain.
    4. Imaging of the SI joint that indicates evidence of injury and/or degeneration.
  7. At least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions.
  8. A trial of at least one therapeutic intra-articular SIJ injection (ie, corticosteroid injection).”

American Society of Interventional Pain Physicians
The American Society of Interventional Pain Physicians (2013) guidelines have been updated.3, The updated guidelines recommend the use of controlled SIJ blocks with placebo or controlled comparative local anesthetic block when indications are satisfied with suspicion of SIJ pain. A positive response to a joint block is considered to be at least a 75% improvement in pain or in the ability to perform previously painful movements. For therapeutic interventions, the only effective modality with fair evidence was cooled radiofrequency neurotomy, when used after the appropriate diagnosis was confirmed by diagnostic SIJ injections.

American Society of Anesthesiologists et al
The American Society of Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine (2010) updated their joint guidelines for chronic pain management.40, The guidelines recommended that “Diagnostic sacroiliac joint injections or lateral branch blocks may be considered for the evaluation of patients with suspected sacroiliac joint pain.” Based on the opinions of consultants and society members, the guidelines recommend that “Water-cooled radiofrequency ablation may be used for chronic sacroiliac joint pain.”

American Pain Society
The practice guidelines from the American Pain Society (2009) were based on a systematic review commissioned by the Society.7,8, The guidelines stated that there was insufficient evidence to evaluate the validity or utility of diagnostic SIJ block as a diagnostic procedure for low back pain with or without radiculopathy; the guidelines further stated that there was insufficient evidence to adequately evaluate the benefits of SIJ steroid injection for nonradicular low back pain.

International Society for the Advancement of Spine Surgery
The International Society for the Advancement of Spine Surgery (2014) updated its policy statement on minimally invasive SIJ fusion in 2016.41,42,Society recommendations indicated that patients who met all of the following criteria may be eligible for minimally invasive SIJ fusion:

  • "Significant SI (sacroiliac) joint pain....or significantly limitations in activities of daily living because of pain from the SI joint(s).
  • "SI joint pain confirmed with … at least 3 positive physical provocation examination maneuvers that stress the SI joint.
  • "Confirmation of the SI joint as a pain generator with ≥ 75% acute decrease in pain immediately following fluoroscopically guided diagnostic intra-articular SI joint block using local anesthetic.
  • "Failure to respond to at least 6 months of non-surgical treatment consisting of non-steroidal anti-inflammatory drugs and/or....one or more of the following:....physical therapy....Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability;
  • "Additional or alternative diagnoses that could be responsible for the patient’s ongoing pain or disability have been considered, investigated and ruled out."

National Institute for Health and Care Excellence
The National Institute for Health and Care Excellence (2017) guidance on minimally invasive SIJ fusion surgery for chronic sacroiliac pain included the following recommendations:

1.1 "Current evidence on the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery for chronic SI pain is adequate to support the use of this procedure....

1.2 Patients having this procedure should have a confirmed diagnosis of unilateral or bilateral SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

1.3 This technically challenging procedure should only be done by surgeons who regularly use image-guided surgery for implant placement. The surgeons should also have had specific training and expertise in minimally invasive SI joint fusion surgery for chronic SI pain.”43,

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this policy are listed in Table 18.

Table 18. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

     

NCT02074761a

Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

250

Aug 2020 (ongoing)

NCT03601949a

Lateral Branch Cooled Radiofrequency Denervation vs Conservative Therapy for Sacroiliac Joint Pain

208

Nov 2021 (recruiting)

NCT03507049

Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain (SIFSO)

60

Apr 2023 (recruiting)

Unpublished

     

NCT01861899a

Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System

55

Nov 2018 (unknown)

NCT02270203a

LOIS: Long-Term Follow-Up in INSITE/SIFI

103

Dec 2019 (completed)

NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.

References

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  2. Simopoulos TT, Manchikanti L, Gupta S et al. Systematic Review of the Diagnostic Accuracy and Therapeutic Effectiveness of Sacroiliac Joint Interventions. Pain Physician, 2015 Oct 3;18(5). PMID 26431129
  3. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. Apr 2013;16(2 Suppl): S49-283. PMID 23615883
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  6. Rupert MP, Lee M, Manchikanti L, et al. Evaluation of sacroiliac joint interventions: a systematic appraisal of the literature. Pain Physician. Mar-Apr 2009;12(2):399-418. PMID 19305487
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  11. Kim WM, Lee HG, Jeong CW, et al. A randomized controlled trial of intra-articular prolotherapy versus steroid injection for sacroiliac joint pain. J Altern Complement Med. Dec 2010;16(12):1285-1290. PMID 21138388
  12. Kennedy DJ, Engel A, Kreiner DS, et al. Fluoroscopically guided diagnostic and therapeutic intra-articular sacroiliac joint injections: a systematic review. Pain Med. Aug 2015;16(8):1500-1518. PMID 26178855
  13. Chen CH, Weng PW, Wu LC et al. Radiofrequency neurotomy in chronic lumbar and sacroiliac joint pain: A meta-analysis. Medicine (Baltimore), 2019 Jul 3;98(26). PMID 31261580
  14. Sun HH, Zhuang SY, Hong X et al. The efficacy and safety of using cooled radiofrequency in treating chronic sacroiliac joint pain: A PRISMA-compliant meta-analysis. Medicine (Baltimore), 2018 Feb 9;97(6). PMID 29419679
  15. Aydin SM, Gharibo CG, Mehnert M, et al. The role of radiofrequency ablation for sacroiliac joint pain: a meta-analysis. PM R. Sep 2010;2(9):842-851. PMID 20869684
  16. Mehta V, Poply K, Husband M et al. The Effects of Radiofrequency Neurotomy Using a Strip-Lesioning Device on Patients with Sacroiliac Joint Pain: Results from a Single-Center, Randomized, Sham-Controlled Trial. Pain Physician, 2018 Dec 5;21(6). PMID 30508988
  17. Juch JNS, Maas ET, Ostelo R, et al. Effect of radiofrequency denervation on pain intensity among patients with chronic low back pain: The Mint Randomized Clinical Trials. JAMA. Jul 04 2017;318(1):68-81. PMID 28672319
  18. van Tilburg CW, Schuurmans FA, Stronks DL, et al. Randomized sham-controlled double-blind multicenter clinical trial to ascertain the effect of percutaneous radiofrequency treatment for sacroiliac joint pain: three-month results. Clin J Pain. Nov 2016;32(11):921-926. PMID 26889616
  19. Zheng Y, Gu M, Shi D, et al. Tomography-guided palisade sacroiliac joint radiofrequency neurotomy versus celecoxib for ankylosing spondylitis: an open-label, randomized, and controlled trial. Rheumatol Int. Sep 2014;34(9):1195-1202. PMID 24518967
  20. Patel N, Gross A, Brown L, et al. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. Mar 2012;13(3):383-398. PMID 22299761
  21. Patel N. Twelve-month follow-up of a randomized trial assessing cooled radiofrequency denervation as a treatment for sacroiliac region pain. Pain Pract. Feb 2016;16(2):154-167. PMID 25565322
  22. Whang P, Cher D, Polly D, et al. Sacroiliac joint fusion using triangular titanium implants vs non-surgical management: six-month outcomes from a prospective randomized controlled trial. Int J Spine Surg. Mar 2015;9:6. PMID 25785242
  23. Polly DW, Cher DJ, Wine KD, et al. Randomized controlled trial of minimally invasive sacroiliac joint fusion using triangular titanium implants vs nonsurgical management for sacroiliac joint dysfunction: 12-month outcomes. Neurosurgery. Nov 2015;77(5):674-691. PMID 26291338
  24. Polly DW, Swofford J, Whang PG, et al. Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs non-surgical management for sacroiliac joint dysfunction. Int J Spine Surg. Sep 2016;10:28. PMID 27652199
  25. Darr E, Meyer SC, Whang PG et al. Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl), 2018 Apr 21;11:113-121. PMID 29674852
  26. Sturesson B, Kools D, Pflugmacher R, et al. Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management. Eur Spine J. Mar 2017;26(3):708-719. PMID 27179664
  27. Dengler J, Sturesson B, Kools D, et al. Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial. Acta Neurochir (Wien). Nov 2016;158(11):2219-2224. PMID 27629371
  28. Dengler JD, Kools D, Pflugmacher R, et al. 1-Year results of a randomized controlled trial of conservative management vs minimally invasive surgical treatment for sacroiliac joint pain. Pain Physician. Sep 2017;20(6):537-550. PMID 28934785
  29. Duhon BS, Cher DJ, Wine KD, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: a prospective study. Global Spine J. May 2016;6(3):257-269. PMID 27099817
  30. Duhon BS, Bitan F, Lockstadt H, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: 2-year follow-up from a prospective multicenter trial. Int J Spine Surg. May 2016;10:13. PMID 27162715
  31. Vanaclocha V, Herrera JM, Saiz-Sapena N, et al. Minimally invasive sacroiliac joint fusion, radiofrequency denervation, and conservative management for sacroiliac joint pain: 6-year comparative case series. Neurosurgery. Apr 20 2017. PMID 28431026
  32. Spain K, Holt T. Surgical revision after sacroiliac joint fixation or fusion. Int J Spine Surg. Apr 2017;11:5. PMID 28377863
  33. Sachs D, Kovalsky D, Redmond A, et al. Durable intermediate-to long-term outcomes after minimally invasive transiliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). Jul 2016;9:213-222. PMID 27471413
  34. Schoell K, Buser Z, Jakoi A, et al. Postoperative complications in patients undergoing minimally invasive sacroiliac fusion. Spine J. Nov 2016;16(11):1324-1332. PMID 27349627
  35. Tran ZV, Ivashchenko A, Brooks L. Sacroiliac Joint Fusion Methodology - Minimally Invasive Compared to Screw-Type Surgeries: A Systematic Review and Meta-Analysis. Pain Physician, 2019 Feb 1;22(1). PMID 30700066
  36. Rappoport LH, Luna IY, Joshua G. Minimally Invasive sacroiliac joint fusion using a novel hydroxyapatite-coated screw: preliminary 1-year clinical and radiographic results of a 2-year prospective study. World Neurosurg. May 2017;101:493-497. PMID 28216399
  37. Araghi A, Woodruff R, Colle K et al. Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial. Open Orthop J, 2017 Dec 27;11:1440-1448. PMID 29387289
  38. Cross WW, Delbridge A, Hales D et al. Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System. Open Orthop J, 2018 Feb 13;12:7-16. PMID 29430266
  39. North American Spine Society (NASS). NASS coverage policy recommendations: Percutaneous sacroiliac joint fusion. 2015; https://www.spine.org/ProductDetails?productid={9EAC3FC6-AF81-E611-851E-005056AF031E}. Accessed October 7, 2019.
  40. American Society of Anesthesiologists Task Force on Chronic Pain Management, American Society of Regional Anesthesia and Pain Medicine. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. Apr 2010;112(4):810-833. PMID 20124882
  41. Lorio MP, Rashbaum R. ISASS policy statement - minimally invasive sacroiliac joint fusion. Int J Spine Surg. Feb 2014;8. PMID 25694942
  42. Lorio MP. ISASS policy statement -- Minimally invasive sacroilliac joint fusion (July 2016). 2016; http://www.isass.org/public-policy/isass-policy-statement-minimally-invasive-sacroiliac-joint-fusion-july-2016/ Accessed October 7, 2019.
  43. National Institute for Health and Care Excellence. Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain [IPG578]. 2017; https://www.nice.org.uk/guidance/ipg578. Accessed October 7, 2019.

Coding Section

Codes Numbers Description
CPT See Policy Guidelines  
ICD-9 Procedure 88.32 Contrast arthrogram
ICD-9 Diagnosis 720.2 Sacroilitis, not elsewhere classified
  724.6 Disorders of the sacrum (listed as the code for sacroiliac pain)
HCPCS G0259 Injection procedure for sacroiliac joint; arthrography
  G0260 Injection procedure for sacroiliac joint; provision of anesthetic, steroid and/or other therapeutic agent, with or without arthrography
ICD-10-CM (effective 10/01/15) M46.1 Sacroilitis, not elsewhere classified
  M47.898 Other spondylosis, sacral and sacrococcygeal region
  M47.899 Other spondylosis, site unspecified
  M48.08 Spinal stenosis, sacral and sacrococcygeal region
  M532X8 Spinal instabilities, sacral and sacrococcygeal region
  M54.18 Radiculopathy, scral and sacrococcygeal region
  M54.30-M54.32 Sciatica; code range
  M54.40-M54.42 Lumbago with sciatica; code range
  M54.5 Lower back pain
  M54.6 Pain in thoracic spine
  S33.2 Dislocation of sacroiliac and sacrococcygeal join
  S33.6 Sprain of sacroiliac joint
ICD-10-PCS (effective 10/01/15) 3E0U33Z, 3E0U3BZ, 3E0U3JZ, 3E0U3NZ Administration, physiological systems and anatomical regions, introduction, joints, percutaneous, code by substance introduced (anti-inflammatory, anesthetic, contrast agent, analgesic)
  BR0D0ZZ Imaging, plain radiography of sacroiliac joints using high osmolar contrast
  BR0D1ZZ Imaging, plain radiography of sacrolilac joints using low osmolar contrast
  BR0DYZZ Imaging, plain radiography of sacroiliac joints using other contrast
  0S573ZZ, 0S583ZZ Surgical, lower joints, destruction, sacroiliac joints (right and left codes), no device
Type of Service Radiology  
Place of Service Outpatient  

Index
Arthrography, Sacroiliac Joint
Sacroiliac Join, Arthrodesis
Sacroiliac Joint, Arthrography
Sacroiliac Joint, Radiofrequency Ablation

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

02/03/2020 

Annual review, no change to policy intent. Updating rationale and references. 

02/13/2019 

 Annual review. No change to policy or intent. Updating description, background, and references.

03/13/2018 

Annual review, updating related policies, background, description, rationale and references.

01/31/2018 

Interim review, updating title to indicate this policy relates to non surgical treatment of SI joint pain, as a new policy title, Sacroiliac Joint Fusion of Stabilization, is being published. Removing surgical treatment from multiple areas of the policy. No change to the intent of diagnosis and nonsurgical treatment of SI joint pain

02/01/2017 

Annual review, no change to policy intent. Updating background, description, guidelines, rationale and references.

02/15/2016 

Annual review, no change to policy intent. 

02/16/2015 

Added verbiage related to cooled RFA to guidelines. 

12/16/2014 

Updated to add: Injection of corticosteroid may be considered medically necessary for the treatment of sacroiliac joint.

02/24/2014

Annual review.  Added regulatory status & related policies.  Updated rationale, references and policy verbiage related to S/I fusion & stabilization. Intent unchanged.  


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