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EM Stimulation Therapy: Supporting Materials (Part 2)
OBJECTIVE: Recent evidence suggests that fibromyalgia is a disorder characterized by dysfunctional brain activity. Because transcranial direct current stimulation (tDCS) can modulate brain activity noninvasively and can decrease pain in patients with refractory central pain, we hypothesized that tDCS treatment would result in pain relief in patients with fibromyalgia. METHODS: Thirty-two patients were randomized to receive sham stimulation or real tDCS with the anode centered over the primary motor cortex (M1) or the dorsolateral prefrontal cortex (DLPFC) (2 mA for 20 minutes on 5 consecutive days). A blinded evaluator rated the patient's pain, using the visual analog scale for pain, the clinician's global impression, the patient's global assessment, and the number of tender points. Other symptoms of fibromyalgia were evaluated using the Fibromyalgia Impact Questionnaire and the Short Form 36 Health Survey. Safety was assessed with a battery of neuropsychological tests. To assess potential confounders, we measured mood and anxiety changes throughout the trial. RESULTS: Anodal tDCS of the primary motor cortex induced significantly greater pain improvement compared with sham stimulation and stimulation of the DLPFC (P < 0.0001). Although this effect decreased after treatment ended, it was still significant after 3 weeks of followup (P = 0.004). A small positive impact on quality of life was observed among patients who received anodal M1 stimulation. This treatment was associated with a few mild adverse events, but the frequency of these events in the active-treatment groups was similar to that in the sham group. Cognitive changes were similar in all 3 treatment groups. CONCLUSION: Our findings provide initial evidence of a beneficial effect of tDCS in fibromyalgia, thus encouraging further trials.
OBJECTIVE: Evidence suggests that fibromyalgia (FM) is a centrally mediated pain disorder. Antidepressants, including electroconvulsive therapy, provide some symptomatic relief in FM and other pain disorders. Repetitive transcranial magnetic stimulation (rTMS) is a new antidepressant treatment, which may also be useful in treating chronic pain. All had improvement in pain, and two had complete resolution of pain. Only one of the four subjects had an antidepressant response. CONCLUSIONS: These preliminary findings suggest a possible role for rTMS in treating FM.
The goal of our study was to determine the efficacy of Farabloc, an electromagnetic shielding fabric compared to placebo fabric when worn as a nightgown, as an analgesic in patients hospitalized with fibromyalgia. In a rheumatologic and rehabilitation hospital, we performed a phase 1, single-blind study of patients using Farabloc (F) or placebo (P) gowns for 8 h per night during the 20-day hospitalization and a phase 2, single-blind crossover study of patients using both F and P gowns randomly and alternatively switching after 10 of 21 days hospitalization (phase 1: 42 F, mean age 49.02 years, 35 female, 7 male; 84 P, mean age 48.08 years, 72 female, 12 males; phase 2: 25 F/P, P/F, or P/P, mean age 44.0 years, 24 female, 1 male). The study involved randomly selected and blinded use of hospital gown 8 h per night of either F or P fabric. The main outcome measures were changes from admission or midpoint to discharge in quantity of pain (QN), quality of pain (QL), and paracetamol use (PU). In phase 1, all three variables significantly favored F over P when using paired t test, two sample t test, Mann-Whitney, and analysis of covariance tests. QN was reduced (F = -2.03 -/+ 0.99*, P = 0.59 -/+ 0.71). QL was reduced (F = -10.64 -/+ 5.69*, P = -2.54 -/+ 3.40). PU was reduced (F = 10.69 -/+ 6.68*, P = 26.12 -/+ 9.37). In phase 2, comparing midpoint to discharge levels in the three variables again favored P/F over F/P and P/P (>0.001): QN (P/F +16.00 -/+ 8.35* F/P -13.27 -/+ 11.40), QL (P/F +8.71 -/+ 4.75* F/P -6.55 -/+ 5.59), and PU (F -9.29 -/+ 4.39* P -18.00 -/+ 5.27) (*p = < 0.001). Patients with fibromyalgia had less pain after sleeping in a gown made of Farabloc than with a placebo fabric. This suggests that Farabloc, an electromagnetic shielding fabric, has analgesic properties in fibromyalgia. Reduced pain observation is consistent with previous studies in phantom limb pain and delayed onset muscle pain. Limitations of this study include single blind design, small sample size, and in phase 2, a lack of washout period and a F/F group. |
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