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MP 1.01.13

H-wave Electrical Stimulation


Medical Policy
Section
Durable Medical Equipment
 
Original Policy Date
11/01/97

Last Review Status/Date
Reviewed with literature search/11:2011

Issue
11:2011
Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


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.

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, CA) 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.


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 


Policy Guidelines

 


Benefit Application
BlueCard/National Account Issues

When used by a physician, physiatrist, podiatrist, or chiropractor, H-wave stimulation may be billed by using CPT code 97014 (unattended electrical stimulation). This is a nonspecific CPT code and thus does not distinguish H-wave stimulation from other forms of electrical stimulation. However, when electrical stimulation is prescribed for use in the home, rental or purchase of H-wave devices may be identified by use of the HCPCS code E0745 (neuromuscular stimulator, electronic shock unit).

State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.


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 2010 through September 2011. 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, 2 RCTs and 3 observational studies, met inclusion criteria. Four of the studies used a measure of pain reduction. In a pooled analysis of data from these 4 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, by Kumar and Marshall published a randomized controlled trial 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 2 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 4 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 2 months or more. Exclusion criteria were similar to those used in the earlier study. Amitriptyline was administered for 4 weeks initially, and those who had a partial response or no response were later randomized to the 2 groups. After excluding 3 amitriptyline responders, the active stimulation group included 14 patients and the sham stimulation included 9 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 4 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 if 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 over 1 year and achieved a 44% reduction in symptoms.

Two observational studies on the H-Wave device were published by Blum and colleagues and consisted of patient’s responses to 3 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% 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% improvement. Following an average 87 days of use, 65% of respondents reported a decrease the amount of medication needed, 79% reported an increase in function and activity, and 78% of respondents reported an improvement in pain of 25% or greater.

Wound healing

The only published study identified in literature searches was a case report from 2010 describing outcomes in 3 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 a day 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 post-operative 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 post-operative strength. The authors also stated that there was no statistically significant difference on any of the other 4 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 randomized controlled trial 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.

Medicare National Coverage
No national coverage determination

 

References:

  1. Food and Drug Administration. Warning letter. September 17, 1997. Available online: http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1997/UCM065904.pdf. Last accessed October 11, 2010.
  2. 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.
  3. Kumar D, Marshall HJ. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care 1997; 20(11):1702-5.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.

 

Codes

 

Description

CPT    Electrical stimulation, unattended 
ICD-9 Procedure  93.39 Other physical therapy 
ICD-9 Diagnosis    Investigational for all codes 
HCPCS  E0745 Neuromuscular stimulator, electronic shock unit 
ICD-10-CM (effective 10/1/13)       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 10/1/13)    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 


Index

 

Electrical Stimulation, H-wave
H-wave Electrical Stimulation
Nerve Stimulation, H-wave


Policy History

 

Date Action Reason
11/01/97 Add toDurable Medical Equipment section New policy
12/18/02 Replace policy Policy updated with additional references; no change in policy statement
02/25/04 Replace policy Policy updated with literature review; no change in policy statement
05/23/05 Replace policy Literature review update for the period of 2004 through March 2005 identified no new studies; policy statement unchanged
04/25/06 Replace policy Literature review update for the period of 2005 through January 2006 identified no new studies; policy statement unchanged
01/10/08 Replace policy Policy updated with literature review; references 5, 6 added; no change in policy statement.
09/10/09 Replace policy Policy updated with literature review; reference number 7 added; no change in policy statement.
11/11/10 Replace policy Policy updated with literature review. Rationale extensively rewritten; references numbers 1, 8 and 9 added; other references re-numbered or removed. Policy statement remained investigational; additional wording was added to clarify that is investigational for all indications, including but not limited to those discussed in the Rationale section.
11/10/11 Replace policy Policy updated with literature review. Policy statement unchanged.