Electroconvulsive Therapy for Refractory Fibromyalgia: a Multicenter, Prospective, Randomized, Open-labelled, Wait-list Controlled Trial

Fibromyalgia is a chronic condition characterized by widespread pain and frequently accompanied by sleep disturbance, fatigue, cognitive symptoms, and impaired daily functioning. Its pathophysiology is complex and is thought to involve abnormal central pain processing and sensitization, together with biological and psychosocial factors. Although current management combines pharmacological and nonpharmacological approaches, many patients continue to experience substantial symptoms despite optimized treatment. These patients may be described as having refractory fibromyalgia.

Electroconvulsive therapy (ECT) is an established neuromodulation treatment that is usually used for severe psychiatric disorders. Previous clinical observations and small prospective studies have suggested that ECT may also influence chronic pain through effects on central sensitization, pain-related cortical networks, descending pain inhibition, and neuroplasticity. However, the analgesic effect of ECT in fibromyalgia remains uncertain because previous studies were limited by small sample sizes, heterogeneous patient populations, and nonrandomized designs. A prospective randomized study is therefore needed to evaluate this treatment approach more rigorously.

This study will compare bilateral ECT plus stable usual treatment with stable usual treatment alone during an initial randomized phase. Participants assigned to immediate treatment will receive a standardized course of bilateral ECT under general anesthesia, with stimulus dosing adjusted according to seizure adequacy and clinical tolerability. Participants assigned to the wait-list group will continue their usual treatment during the initial control period and will subsequently be offered ECT. Usual treatment will continue during the study, and permitted as-needed analgesic medication may be used according to the protocol.

The study will assess whether ECT is associated with improvement in pain and broader fibromyalgia-related outcomes, including functional impact, sleep quality, mood symptoms, quality of life, and participants' global perception of change. Cognitive function, subjective memory complaints, postictal confusion, concomitant medication use, and adverse events will also be monitored to characterize the safety and tolerability of ECT. Outcome assessments and statistical analyses will be conducted by personnel blinded to treatment allocation where feasible. The study may provide preliminary randomized evidence to guide future research on ECT parameters, patient selection, treatment durability, and the role of neuromodulation in refractory fibromyalgia.