Durable Medical Equipment Section - Sympathetic Therapy for the Treatment of Pain

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Sympathetic therapy describes a type of electrical stimulation of the peripheral nerves that is designed to stimulate the sympathetic nervous system in an effort to "normalize" the autonomic nervous system and alleviate chronic pain. Unlike TENS (transcutaneous electrical nerve stimulation) or interferential electrical stimulation, sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic effect on sympathetically induced pain.

Sympathetic therapy uses four intersecting channels of various frequencies with bilateral electrode placement on the feet, legs, arms, and hands. Based on the location of the patient’s pain and treatment protocols supplied by the manufacturer, electrodes are placed in various locations on the lower legs and feet or the hands and arms. Electrical current is then induced with beat frequencies between 0 and 1000 Hz. Treatment may include daily 1-hour treatments in the physician’s office, followed by home treatments if the initial treatment is effective.

The Dynatron STS device and a companion home device, Dynatron STS Rx, are devices that deliver sympathetic therapy. These devices received U.S. Food and Drug Administration (FDA) clearance in March 2001 through a 510(k) process. The FDA-labeled indication is as follows:

"Electrical stimulation delivered by the Dynatron STS and Dynatron STS Rx is indicated for providing symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain."

Policy/Criteria

Sympathetic therapy is considered investigational.

Scientific Background

Ideally, assessment of therapies designed to treat chronic pain should be based on placebo-controlled trials to assess the magnitude of the expected placebo effect and to isolate the contribution of the active treatment. Outcomes of interest might include changes in scores of a visual analog scale, quality of life measures such as an SF-36, reduction in pain medications, daily activity levels, or return to work. However, a MEDLINE search did not identify any studies published in the peer-reviewed literature regarding sympathetic therapy. An information packet from the manufacturer Dynatron (Salt Lake City, UT) (2) includes two articles also referenced in their promotional material. Although these 2 articles have not been published in the peer-reviewed literature, they are briefly reviewed below.

1. Steven Sacks and colleagues reported on a retrospective study of 197 patients with chronic pain of various origins including upper and lower extremity pain and migraine. Some patients reported multiple sites of pain, and each different site of pain was registered as a separate pain complaint, resulting in 227 patient records. Of these, 91% reported mild pain relief with 33% reporting complete pain relief. A total of 78% reported an increase in their daily living activities by 50% or more, and 69% reported a decrease in medications. No data were reported regarding the various etiologies of pain, prior treatment including baseline drug requirements, exact treatment protocol, the number of treatments, or how pain relief, activities of daily living, or other treatment outcomes were evaluated. There was no control group.
2. Guido reported on the effects of sympathetic therapy in 20 volunteers suffering from chronic pain related to peripheral neuropathy. The treatment protocol varied with the site of pain, (e.g., upper versus lower extremity), and could vary from day to day. Patients underwent daily therapy for 28 days. At the end of the study, the mean global Visual Analog Scale scores were significantly reduced, although these data are not presented in a table or figure. There was no control group. This study was subsequently published. (3)

Updated guidelines from the Work Loss Data Institute list sympathetic therapy as an intervention that is currently under study and not specifically recommended. (4)

In summary, the lack of published outcomes from well-designed clinical trials prohibits scientific conclusions concerning the health outcome effects of sympathetic therapy for the treatment of pain.  An updated search of the MEDLINE database through March 2009 did not identify any additional clinical trials which alter this conclusion.

In summary, the lack of published outcomes from well-designed clinical trials prohibits scientific conclusions concerning the health outcome effects of sympathetic therapy for the treatment of pain. An updated search of the MEDLINE database through February 19, 2008 did not identify any additional clinical trials which alter this conclusion.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 1.04.03
2. www.chronicpainrx.com (Verified 03/11/09)
3. Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Manage 2002;12(1):31-4
4. Work Loss Data Institute. Pain 2006; National Guideline Clearinghouse, www.guideline.gov (Verified 03/11/09)

Cross References

Electrical Stimulation Devices for Home Use; Regence Medical Policy Manual, DME, Policy No. 11

Interferential Stimulation; Regence Medical Policy Manual, DME, Policy No. 66

Electrical Stimulation for the Treatment of Arthritis, TRG Medical Policy Manual, DME, Policy No. 70

Percutaneous Neuromodulation Therapy (PNT), Regence Medical Policy Manual, Surgery, Policy No. 44

Spinal Cord Stimulation for Treatment of Pain, Regence Medical Policy Manual, Surgery, Policy No. 45

DME Section Table of Contents