CAM 10113

H-wave Electrical Stimulation

Category:Durable Medical Equipment   Last Reviewed:July 2018
Department(s):Medical Affairs   Next Review:July 2999
Original Date:July 2013    

Description:
H-wave stimulation is a distinct form of electrical stimulation, and an H-wave device is U.S. Food and Drug Administration (FDA)-approved for medical purposes that involve repeated muscle contractions. H-wave electrical stimulation has been evaluated primarily as a pain treatment, but it has also been studied for other indications, such as wound healing and improving post-surgical range of motion. Both office-based and home models of the H-wave device are available.

Background:
H-wave stimulation is a form of electrical stimulation that differs from other forms of electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), in terms of its wave form. While H-wave stimulation may be performed by physicians, physiatrists, chiropractors or podiatrists, H-wave devices are also available for home use. H-wave stimulation has been used for the treatment of pain related to a variety of etiologies, such as diabetic neuropathy, muscle sprains, temporomandibular joint dysfunctions or reflex sympathetic dystrophy. H-wave stimulation has also been used to accelerate healing of wounds such as diabetic ulcers and to improve range of motion and function after orthopedic surgery.

H-wave electrical stimulation must be distinguished from the H-waves that are a component of electromyography.

Regulatory Status:
In 1992, the H-Wave® muscle stimulator (Electronic Waveform Lab, Huntington Beach, Calif.) was cleared for marketing by the FDA through the 510(k) process. The FDA classified H-wave stimulation devices as "powered muscle stimulators." As a class, the FDA describes these devices as being "intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area." According to the FDA, manufacturers may make the following claims regarding the effect of the device: "1) relaxation of muscle spasms; 2) prevention or retardation of disuse atrophy; 3) increasing local blood circulation; 4) muscle re-education; 5) immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and, 6) maintaining or increasing range of motion." (1)

Uses of the device not cleared by the FDA include, but are not limited to, treatment of diabetic neuropathy and wound healing.

Related Policies
10109 Transcutaneous Electrical Nerve Stimulation
10124 Interferential Current Stimulation
20157 Electrostimulation and Electromagnetic Therapy for Treating Wounds
70129 Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)

Policy:
The use of H-wave stimulation is considered INVESTIGATIONAL for all indications, including, but not limited to:

  • Treatment of pain
  • Wound healing
  • Post-operative treatment to improve function and/or range of motion

Rationale:
This policy was originally created in 1997 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period September 2011 through September 2012. Most of the studies identified in searches evaluated H-wave stimulation for treating pain. As with other technologies intended to relieve pain, measurement of placebo effects is important and, therefore, the searches focused on placebo (sham)-controlled studies. Studies were also identified on H-wave stimulation for wound healing and post-surgical rehabilitation but not for other clinical applications of the technology.

Following is a summary of the key literature to date:

Pain Treatment
In 2008, Blum and colleagues published a meta-analysis of studies evaluating the H-Wave device for treatment of chronic soft tissue inflammation and neuropathic pain. (2) Five studies, two randomized controlled trials (RCTs) and three observational studies, met inclusion criteria. Four of the studies used a measure of pain reduction. In a pooled analysis of data from these four studies (treatment groups only), the mean weighted effect size was 0.59. Two studies reported the effect of the H-Wave device on pain mediation use. The mean weighted effect size was 0.56. (An effect size of 0.5 is considered a moderate effect and of 0.80 is considered a large effect.) A limitation of this analysis was that the authors did not use data from patients in the control or comparison groups. Thus, the incremental effect of the H-Wave device beyond that of a comparison intervention cannot be determined.

The five studies identified by the systematic review for the meta-analysis were published by two research groups. Kumar and colleagues published three studies, and the other two were published by Blum and colleagues. Blum and several co-investigators are consultants to the device manufacturer. Descriptions of the individual published studies are included below.

In 1997, Kumar and Marshall published an RCT comparing active H-wave electrical stimulation with sham stimulation for treatment of diabetic peripheral neuropathy. (3) The authors selected 31 patients with Type 2 diabetes and painful peripheral neuropathy in both lower extremities lasting at least two months. Patients were excluded if they had vascular insufficiency of the legs or feet or specified cardiac conditions. Patients were randomly assigned to the active group (n=18) or the sham group (n=13). Both groups were instructed to use their devices 30 minutes daily for four weeks. The device used in the sham group had inactive electrodes. Outcomes were assessed using a pain-grading scale (ranging from 0 to 5). Both groups experienced significant declines in pain, and the post-treatment mean grade for the active group was significantly lower than the mean grade for the sham group. This study did not state whether patients and/or investigators were blinded and did not state whether any patients withdrew from the study.

Another randomized study published by Kumar and colleagues in 1998 compared active H-wave electrical stimulation with sham stimulation among patients treated initially with a tricyclic antidepressant. (4) The authors enrolled 26 patients with Type 2 diabetes and painful peripheral neuropathy persisting for two months or more. Exclusion criteria were similar to those used in the earlier study. Amitriptyline was administered for four weeks initially, and those who had a partial response or no response were later randomly assigned to the two groups. After excluding three amitriptyline responders, the active stimulation group included 14 patients, and the sham stimulation included nine patients. Sham devices had inactive output terminals. Stimulation therapy lasted 12 weeks, and final outcome assessment was conducted by an investigator blinded to group assignment four weeks after the end of treatment. As in the earlier study, mean pain grade in both groups improved significantly, but the difference between groups after treatment significantly favored active H-wave stimulation. Results on an analogue scale were similar. It is unclear whether patients were blinded to the type of device, and the report does not note whether withdrawals from the study occurred. A later report from this research group (5) described a case series of 34 patients who continued H-Wave electrical stimulation for more than one year and achieved a 44 percent reduction in symptoms.

Two observational studies on the H-Wave device were published by Blum and colleagues and consisted of patients’ responses to three of 10 questions on a manufacturer’s customer service questionnaire (i.e., warranty registration card). (6, 7) In the larger of the two reports, 80 percent of 8,498 patients with chronic soft tissue injury and neuropathic pain who were given the H-Wave device completed the questionnaire. (7) The answers were compared with an expected placebo response of 37 percent improvement. Following an average 87 days of use, 65 percent of respondents reported a decrease in the amount of medication needed, 79 percent reported an increase in function and activity and 78 percent of respondents reported an improvement in pain of 25 percent or greater.

Wound Healing
The only published study identified in literature searches was a case report from 2010 describing outcomes in three patients with chronic diabetic leg ulcers who used the H-Wave device. (8)

Post-Operative Rehabilitation
In 2009, Blum and colleagues published a small double-blind placebo-controlled randomized trial evaluating home use of the H-Wave device for improving range of motion and muscle strength after rotator cuff reconstruction surgery. (9) Electrode placement for the H-Wave device was done during the surgical procedure. After surgery, patients were provided with an active H-wave device (n=12) or sham device (n=10) and were instructed to use the device for one hour twice daily for 90 days. Individuals in the sham group were told not to expect any sensation from the device. Both groups also received standard physical therapy. At follow-up, range of motion of the involved extremity was compared to that of the uninvolved extremity. At the 90-day postoperative examination, patients in the H-wave group had significantly less loss of external rotation of the involved extremity (mean loss of 11.7 degrees) compared to the placebo group (mean loss of 21.7 degrees), p=0.007. Moreover, there was a statistically significant difference in internal rotation, a mean loss of 13.3 degrees in the H-wave group and a mean loss of 23.3 degrees in the placebo group, p=0.006. There were no statistically significant differences between groups in postoperative strength. The authors also stated that there was no statistically significant difference on any of the other four range-of-motion variables. The study did not assess change in functional status or capacity.

Summary:
Two small controlled trials are insufficient to permit conclusions about the effectiveness of H-wave electrical stimulation as a pain treatment. Additional sham-controlled studies are needed from other investigators, preferably studies that are clearly blinded, specify the handling of any withdrawals and provide long-term, comparative follow-up data. One small RCT represents insufficient evidence on the effectiveness of H-wave simulation for improving strength and function after rotator cuff surgery. No comparative studies have been published evaluating H-wave stimulation to accelerate wound healing. In addition, no studies were identified that evaluated H-wave stimulation for any clinical application other than those described above. Thus, H-wave electrical stimulation is considered investigational.

References:

  1. Blum K, Chen AL, Chen TJ et al. The H-Wave device is an effective and safe non-pharmacological analgesic for chronic pain: a meta-analysis. Adv Ther 2008; 25(7):644-57.
  2. Kumar D, Marshall HJ. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care 1997; 20(11):1702-5.
  3. Kumar D, Alvaro MS, Julka IS et al. Diabetic peripheral neuropathy. Effectiveness of electrotherapy and amitriptyline for symptomatic relief. Diabetes Care 1998; 21(8):1322-5.
  4. Julka IS, Alvaro M, Kumar D. Beneficial effects of electrical stimulation on neuropathic symptoms in diabetes patients. J Foot Ankle Surg 1998; 37(3):191-4.
  5. Blum K, DiNubile NA, Tekten T et al. H-Wave, a nonpharmacologic alternative for the treatment of patients with chronic soft tissue inflammation and neuropathic pain: a preliminary statistical outcome study. Adv Ther 2006; 23(3):446-55.
  6. Blum K, Chen TJ, Martinez-Pons M et al. The H-Wave small muscle fiber stimulator, a nonpharmacologic alternative for the treatment of chronic soft-tissue injury and neuropathic pain: an extended population observational study. Adv Ther 2006; 23(5):739-49.
  7. Blum K, Chen AL, Chen TJ et al. Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE® device therapy: a case series. Cases J 2010; 3:54.
  8. Blum K, Chen AL, Chen TJ et al. Repetitive H-wave device stimulation and program induces significant increases in the range of motion of post-operative rotator cuff reconstruction in a double-blinded randomized placebo controlled human study. BMC Musculoskelet Disord 2009; 10:132.

Coding Section

Codes Number Description
CPT 97014 electrical stimulation, unattended
ICD-9 Procedure 93.39 Other physical therapy
ICD-9 Diagnosis   Investigational for all diagnoses
HCPCS E0745 Neuromuscular stimulator, electronic shock unit
ICD-10-CM (effective 10/01/15)   Investigational for all diagnoses
  G56.40-G56.42 Causalgia of upper limb code range
  G57.70-G57.72 Causalgia of lower limb code range
  G89.0-G89.4 Pain, not elsewhere classified code range
  G90.50-G90.59 Complex regional pain syndrome I code range
  M25.50-M25.579 Pain in joint code range
  M54.00-M54.9 Dorsalgia code range
  M79.60-M79.676 Pain in limb, hand, foot, fingers and toes code range
  R52 Pain, unspecified
ICD-10-PCS (effective 10/01/15)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for the initiation of this therapy.
Type of Service Durable Medical Equipment  
Place of Service Home/Office  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

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     

07/30/2018 

Annual review, no change to policy intent 

07/31/2017 

Annual review, no change to policy intent 

07/06/2016 

Annual review, no change to policy intent.  

07/13/2015 

Annual review, no change to policy intent. Added coding.

07/10/2014

Annual review. Added related policies.


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