Electroconvulsive Therapy for Refractory Fibromyalgia
ConditionFibromyalgia (FM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of fibromyalgia according to the 2010 American College of Rheumatology criteria.
Age 18-70 years.
Refractory fibromyalgia, defined as a FIQR score of 39 or higher and stable standard medical treatment consisting of at least two combined pharmacological treatments, including tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and/or antiepileptic drugs, during the previous 3 months.
Concomitant medications maintained at stable doses for at least 4 weeks before inclusion.
Disqualifiers
History of epilepsy, psychiatrist-diagnosed depression, or head trauma.
Pregnancy or breastfeeding.
Severe systemic disease or poor overall condition.
Contraindication to general anesthesia, including allergy to anesthetic agents or impaired liver or kidney function.
Trial design
Design model
Parallel
Treatments tested in this trial
Electroconvulsive Therapy
Procedure/SurgeryParticipants 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
DrugParticipants 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Wait-list Control With Usual Standard TreatmentActive comparator 1 intervention
Group B: Immediate Bilateral Electroconvulsive TherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Average Pain Intensity From Baseline to 1 Month After Completion of the Initial 4-Week Treatment
Average pain intensity during the preceding week will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating greater pain intensity. The primary outcome is the change in NRS score from baseline to 1 month after completion of the initial 4-week electroconvulsive therapy (ECT) treatment.
Time frame
Baseline and 1 month after completion of the initial 4-week ECT treatmentSecondary outcomes
1
Average Pain Intensity During the Randomized Controlled Phase
Average pain intensity using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating greater pain intensity.
Time frame
3 days, 2 weeks, and 3 months after completion of the initial 4-week ECT treatment period2
Fibromyalgia-related Functional Impairment
Fibromyalgia-related functional impairment and symptom impact during the preceding week will be assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). The total score ranges from 0 to 100, with higher scores indicating greater disease impact and a worse outcome.
Time frame
3 days, 2 weeks, 1 month, and 3 months after completion of the initial 4-week ECT treatment period3
Sleep Quality
Sleep quality and sleep disturbances assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality and a worse outcome.
Time frame
3 days, 2 weeks, 1 month, and 3 months after completion of the initial 4-week ECT treatment period4
Depressive Symptoms
Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II). The questionnaire contains 21 items, each scored from 0 to 3, yielding a total score ranging from 0 to 63. Higher scores indicate more severe depressive symptoms and a worse outcome.
Time frame
3 days, 2 weeks, 1 month, and 3 months after completion of the initial 4-week ECT treatment period.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: