Background/Purpose:

Fibromyalgia (FM) is one of the most common diseases manifested by pain, tenderness and fatigue. FM is still a disorder of unknown etiology that is generally diagnosed according to the ACR criteria. According to Cochrane Reviews, current therapy is clearly and largely not satisfactory (1). Transcutaneous electrical nerve stimulation (TENS) is a non-invasive technique that is used throughout the world to manage painful conditions, although there continues to be uncertainty about efficacy and effectiveness (2). The purpose of TENS is to selectively activate low threshold peripheral afferents as this has been shown to inhibit ongoing transmission of nociceptive input in the spinal cord, leading to pain relief. A variety of TENS-like devices, that differ in design to a standard TENS device, are available to the general public without prescription although there is very little research on mechanisms, efficacy, and effectiveness. Non-invasive Interactive Neuromodulation (INM) is a relatively new TENS-like device and is sold under the trade name Dynamix®. Often pain relief lasts long after the treatment is over which hints at a neuropeptide/cytokine cascade effect and a CNS response. Manufacturers claim that non-invasive INM  relieves pain and promotes healing of various injuries. The aim of our study will be evaluate the safety and efficacy of Dynamix application in FM patient.

Methods:

At the division of Rheumatology of University of Pisa, we enrolled 20 Female affected by Fibromyalgia, with a stable therapeutic regimen for at least 3 month, and we treated with Dinamix (A-circle) for 1 times at week for 6 times. Each patients completed FIQ, SF-36, FACIT-Fatigue scale,  FAS Evaluation. Prior the treatment, at the end of the treatment and after 4 weeks after the end of the study. The INM treatment was applied on all the efferent nerve of the column and on the exit of trigeminal nerve (the treatment was named column basis). A tender point count with tender point index evaluation was performed by a Rheumatologist.

Results: No patient showed an adverse event during the treatment and at the follow up. We found a statistically significant reduction in FIQ, pain evaluated by VAS and SF-36 item, FAS score (both Self-Assessment Pain Scale and total FAS index), Tende Point index (p<0.05). Moreover we found a slight improvement of neck rotation. We don’t found a significant reduction in Tender Poins number. The same results was found at follow up visit, after 4 week from the end of the treatment.

Conclusion:

The INM is a non-invasive technique that require a specific skills to obtain satisfactory results, however, the ease of use and speed of application make it a potentially useful technique in pain management. Moreover the INM  is  well tolerated by the patients. This is a preliminary work that underline the beneficial effects of this treatment in FM patients.   The limit of the study was the absence of the control group, for example a placebo group.