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Fibromyalgia Syndrome (FMS) is a highly prevalent condition often affecting individuals in the prime of life, causing severe reduction in quality of life and productivity, as well as social isolation, anxiety, and depression. The purpose of this study is to explore the efficacy of H1 deep TMS for the treatment of FMS patients. In addition, the investigators attempt to assess the effect of dTMS on the perception and modulation of pain in patients suffering from FMS.
Fibromyalgia Syndrome (FMS) is a highly prevalent condition often affecting individuals in the prime of life, causing severe reduction in quality of life and productivity, as well as social isolation, anxiety, and depression. FMS has recently been estimated to affect approximately 2.6% of the Israeli population. Over the last decade, it has repeatedly been shown that Transcranial Magnetic Stimulation (TMS) of the primary motor cortex (M1) induces an analgesic effect both in experimental pain, as well as in various chronic pain conditions, possibly by activating intrinsic pain-modulation systems.
Thus, the purpose of this study is to explore the efficacy of H1 deep TMS for the treatment of FMS patients. In addition, the investigators attempt to assess the effect of dTMS on the perception and modulation of pain in patients suffering from FMS.
The study will take place in Shalvata Mental Health Center, After receiving the hospital's BRI approval. Forty FMS patients between 18-65 years of age will sign an informed consent form, and be randomized to an active arm (dTMS) and a placebo arm (sham-dTMS). Twenty treatments will be delivered to each subject over a period of 4 weeks. At base-line subjects will complete a series of epidemiological and clinical questionnaires (assessing symptoms of FMS, depression, pain, anxiety), as well as pain sensation and modulation tests. At the termination of the study and two weeks after the final treatment all questionnaires and physical measurements will be re-administered for a final assessment of post-treatment status comparison with initial status The importance of the study lies in its potential to: 1) provide evidence for the efficacy of dTMS in treating patients suffering from FMS 2)enhance the investigators understanding of the pathophysiology of FMS and its underlying pain perception and modulation mechanisms 3) explore the role of the Dorso-Lateral-Prefrontal-Cortex (DLPC) in modulating pain and as a possible target to further therapeutic interventions in FMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open - single arm | Experimental | All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dTMS | Device | All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| pain intensity - past 24h | Change in self-reported average pain intensity over the last 24 hours will be measured at the end point with the numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ. | at baseline, and after treatment number 5, 10, 15 and 20, in addition to a final examination on follow up (two weeks after determination). |
| Measure | Description | Time Frame |
|---|---|---|
| pain dimensions |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shalvata MHC | Hod Ha-sharon | Israel |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| baseline and follow up (two weeks after determination of treatment). |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |