Comparing Home-Based Transcranial Direct Current Stimulation to Duloxetine for Treating Fibromyalgia in Women Aged 18 to 75

What this Trial Is About

Fibromyalgia is a condition marked by widespread pain, fatigue, poor sleep, and cognitive changes that lower quality of life and often cause work absence or early retirement. Many patients stop using antidepressants or anticonvulsants due to side effects or poor results, and some rely on opioids. Because treatment options are limited, researchers are studying transcranial direct current stimulation tDCS as a potential alternative, comparing its effects to duloxetine in a randomized, double-blind clinical trial to see if tDCS is not worse than duloxetine when both are combined with exercise and pain education. Participants will be divided into three groups one receiving 28 daily home-based sessions of active anodal tDCS targeting the primary motor cortex, combined with placebo medication another taking duloxetine at varying doses combined with sham tDCS and a third receiving sham tDCS with placebo pills. Duloxetine dosing starts with 30 mg and increases to 60 mg, tapering off after treatment. The tDCS sessions last 20 minutes each, with electrodes placed using special caps. Both treatments include physical exercises and educational sessions on pain. The study includes a run-in period, treatment phase, and follow-up assessments at 3, 6, and 12 months. During the study, participants will perform weekly home assessments of pain interference, global improvement, quality of life, cognitive symptoms, and pain inhibitory system function. Secondary outcomes include depressive symptoms, sleep quality, circadian rhythm, analgesic use, functional capacity, various pain thresholds, cognitive tests, treatment adherence, side effects, and satisfaction. Biological markers like genetic variants, inflammatory proteins, and brain activity will also be analyzed. Safety and progress will be monitored with an interim analysis to decide on continuing or stopping the trial. The total involvement spans treatment and follow-up visits over a year.

Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine: Non-inferiority Clinical Trial (FIBROSTIM)