Sympathetic Therapy for the Treatment of Pain (Archived)
Durable Medical Equipment
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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 4 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.'
Sympathetic therapy is considered investigational.
When sympathetic therapy is administered in the physician's office, CPT code 97014 or 97032 may be used, which describes unattended and attended electrical stimulation therapy, respectively. These CPT codes are not specific for sympathetic therapy, and thus when offered in the office or clinic, based on CPT code alone, sympathetic therapy cannot be distinguished from other types of electrical stimulation.
After a successful trial period in the office, home therapy may be recommended, using either a rented or purchased device. There is no HCPCS code that explicitly describes sympathetic therapy, and the manufacturer reports that a nonspecific HCPCS code such as A9900 (miscellaneous DME supply, accessory, and/or service component of another HCPCS code) may be used. However, it is possible that a HCPCS code for TENS might be used (e.g., E0730 Transcutaneous electrical nerve stimulation (TENS), four or more leads, for multiple nerve stimulation).
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State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational. However, this policy considers specific applications of an FDA-approved device as investigational. Alternatively, FDA-approved devices may be assessed on the basis of their medical necessity.
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 Dynatronics (Salt Lake City, UT) (1) includes 2 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. 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, i.e., 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 VAS scores were significantly reduced, although these data are not presented in a table or figure. There was no control group.
A review of the peer-reviewed literature on MEDLINE from the period of 2002 through June 2005 found no published articles on sympathetic therapy for chronic pain other than the Guido study listed here, which was subsequently published. (2) Therefore, the policy is unchanged.
A search of the MEDLINE database for the period of April 2005 through September 2006 retrieved no published studies on sympathetic therapy. Updated guidelines from the Work Loss Data Institute list sympathetic therapy as an intervention that is currently under study and not specifically recommended. (3) Therefore, the policy is unchanged.
A search of the MEDLINE database for the period of October 2006 through January 2008 did not identify any studies on sympathetic therapy. Therefore, the policy statement is unchanged.
- Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Manage 2002;12(1):31-4
- Work Loss Data Institute. Pain. 2006; National Guideline Clearinghouse,www.guideline.gov
|CPT||97014||Application of a modality to 1 or more areas; electrical stimulation (unattended)|
|97032||Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes (constant attendance)|
|HCPCS||A9900||Miscellaneous DME supply, accessory, and/or service component of another HCPCS code may be used|
|E0730||Transcutaneous electrical nerve stimulation (TENS) device, 4 or more leads, for multiple nerve stimulation|
|Type of Service||Durable Medical Equipment|
|Place of Service||Office, Home|
|02/15/02||Add to Durable Medicine section||New policy|
|07/17/03||Replace policy||Policy reviewed with literature search, policy statement unchanged|
|11/9/04||Replace policy||Policy reviewed with literature search, policy statement unchanged|
|08/17/05||Replace policy||Policy reviewed with literature search, policy statement unchanged|
|12/12/06||Replace policy||Policy reviewed; reference 3 added; policy statement unchanged.|
|03/13/08||Replace policy||Policy reviewed with literature search, policy statement unchanged|