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Electroconvulsive Therapy for Refractory Fibromyalgia
Sponsor: Beijing Tiantan Hospital
Summary
This multicenter, prospective, randomized, open-label, wait-list controlled trial will evaluate the efficacy and safety of bilateral electroconvulsive therapy (ECT) for adults with refractory fibromyalgia (FM). Participants will be recruited from Beijing Tiantan Hospital and Beijing Jianjia Rehabilitation Hospital. Eligible participants will have FM diagnosed according to the 2010 American College of Rheumatology criteria, will have received stable standard medical treatment including at least two combined pharmacological treatments during the previous 3 months, and will have substantial disease-related functional impairment as indicated by a Revised Fibromyalgia Impact Questionnaire (FIQR) score of 39 or higher. Concomitant medications will remain at stable doses during the study whenever possible. Participants will be randomized to an immediate ECT group or a wait-list control group. Participants in the immediate group will receive bilateral ECT in addition to their usual standard treatment. ECT will be administered under general anesthesia using a standardized bilateral electrode placement and individualized stimulus dosing, with 1 to 2 treatment sessions per week for a total of 6 sessions over 4 weeks. Participants in the wait-list group will continue usual standard treatment during the initial randomized control period and will subsequently be offered the same 4-week ECT course. The primary outcome is the change in average pain intensity, measured using the 0-10 Numeric Rating Scale (NRS), from baseline to 1 month after completion of the initial 4-week treatment or control period. Secondary outcomes include pain intensity, FM-related functional impairment, sleep quality, depressive symptoms, health-related quality of life, patient-reported global improvement, cognitive function, memory complaints, postictal confusion, and adverse events. Follow-up assessments will continue for 3 months after ECT or the corresponding control period. Outcome assessors and statisticians will be blinded to treatment allocation.
Official title: Electroconvulsive Therapy for Refractory Fibromyalgia: a Multicenter, Prospective, Randomized, Open-labelled, Wait-list Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2026-12-01
Completion Date
2028-04-01
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Electroconvulsive Therapy
Participants will continue their usual stable standard treatment for fibromyalgia throughout the study and will receive bilateral electroconvulsive therapy (ECT) beginning within 1 week after enrollment. ECT will be performed under general anesthesia using intravenous propofol for induction and succinylcholine for muscle relaxation, with bilateral electrode placement and individualized stimulus dosing. Participants will receive 1-2 ECT sessions per week, for a total of 6 sessions over 4 weeks. Standard treatment and concomitant medications will be maintained at stable doses whenever possible. Celecoxib 200 mg as needed, up to twice daily, and tramadol 100 mg as needed, up to 400 mg daily, may be used for analgesia according to the protocol.
Standard medical treatment
Participants will continue their usual stable standard treatment for fibromyalgia during the initial 4-week randomized control period without receiving ECT. Standard treatment and concomitant medications will be maintained at stable doses whenever possible. Celecoxib 200 mg as needed, up to twice daily, and tramadol 100 mg as needed, up to 400 mg daily, may be used for analgesia according to the protocol. After completion of the randomized control phase and the specified follow-up assessments, participants will be offered a 4-week course of bilateral ECT combined with their usual standard treatment, using the same ECT procedures as the immediate-treatment group.