The effects of neuromodulation through brainwave entrainment on pain in women with fibromyalgia: a randomized controlled clinical trial with follow-up
Abstract
Background: Fibromyalgia is a syndrome characterized by chronic, widespread pain. Its pathogenesis is not well-defined, but cumulative evidence indicates fibromyalgia is associated with alterations in brain surface wave frequencies.
Objective: This study investigated the effects of brainwave entrainment (BWE) vs. music therapy for managing fibromyalgia in women.
Methods: Eighty-four female patients with fibromyalgia were randomly assigned to 2 groups, namely music therapy (n = 42) or BWE administered using a BrainTap headset (n = 42). The music therapy and BWE groups were treated for 20 minutes daily, 5 times a week, over 8 weeks. Visual analog scale (VAS) for pain, McGill pain questionnaire (MPQ), fibromyalgia impact questionnaire (FIQ), and SF-36 quality of life questionnaire were applied at baseline, during the treatment, and post-intervention with a 6-month follow-up. Biochemical analyses and the Hamilton Depression and Anxiety Rating Scale (HAM-A and HAM-D) were performed at baseline and at the conclusion of the treatment.
Results: BWE group reduced pain (P = .0001) as measured by the VAS and MPQ in the PRI total score and anxiety (P = .006). Furthermore, BWE improved parameters related to quality of life (BWE P = .002 vs MT P = .035), depression (BWE P = .0001 vs MT P = .006), and oxidative stress, and reduced BDNF (BWE P = .049 vs MT P = .030) levels in patients with fibromyalgia, an effect also observed with music therapy.
Conclusions: BWE delivered through the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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