The effects of neuromodulation through brainwave entrainment on pain in women with fibromyalgia: a randomized controlled clinical trial with Follow-Up

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 two 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, five times a week, over eight 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 six-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 = 0.0001) as measured by the VAS and MPQ in the PRI total score and anxiety (p = 0.006). Furthermore, BWE improved parameters related to quality of life (BWE p = 0.002 vs MT p = 0.035), depression (BWE p = 0.0001 vs MT p = 0.006), and oxidative stress, and reduced BDNF (BWE p = 0.049 vs MT p = 0.030) levels in patients with fibromyalgia, an effect also observed with music therapy. CONCLUSIONS: BWE delivered through the BrainTap headset has the potential to alleviate pain and improve the quality of life in women with fibromyalgia. This effect appears to be related to oxidative stress and BDNF levels reduction.