An interventional study of Electroconvulsive Therapy and Standard medical treatment in Fibromyalgia (FM), sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 58 is close to the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will continue their usual stable standard treatment for fibromyalgia during the initial 4-week randomized control period without receiving ECT. Celecoxib and tramadol may be used as-needed for analgesia according to the study protocol. After completion of the randomized control phase and the required follow-up assessments, participants will be offered the same 4-week course of bilateral ECT as the immediate-treatment group.
Drug: Standard medical treatment
Participants will continue their usual standard treatment and will receive a 4-week course of bilateral electroconvulsive therapy (ECT) beginning within 1 week after enrollment. ECT will be administered under general anesthesia using bilateral electrode placement, with 1-2 treatment sessions per week for a total of 6 sessions. Stimulus dosing will be individualized according to seizure adequacy and the predefined dose-escalation protocol. As-needed analgesia with celecoxib or tramadol may be used according to the study protocol.
Procedure: Electroconvulsive Therapy · Drug: Standard medical treatment
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.
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.
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 treatment
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 period
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 period
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 period
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.
Health-related Quality of Life
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire assesses eight domains: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored separately from 0 to 100, with higher scores indicating better health status and a better outcome.
Time frame: 3 days, 2 weeks, 1 month, and 3 months after completion of the initial 4-week ECT treatment period
Patient Global Impression of Change
Participants' overall perception of change since the start of the study, rated on a 7-point scale ranging from "very much improved" to "very much worse."
Time frame: 3 days, 2 weeks, 1 month, and 3 months after completion of the initial 4-week ECT treatment period
Average Pain Intensity After Delayed ECT
Average pain intensity during the preceding week will be assessed in the wait-list group after delayed electroconvulsive therapy using the Numeric Rating Scale (NRS). Scores range from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating greater pain intensity and a worse outcome.
Time frame: 3 days, 2 weeks, 1 month, and 3 months after completion of the delayed 4-week ECT treatment course
Cognitive function measures
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive function and a better outcome.
Time frame: Baseline and 3 days, 2 weeks, 1 month, and 3 months after completion of the initial 4-week ECT treatment period
Adverse Events
All adverse events occurring during the study will be monitored, recorded, and summarized.
Time frame: From enrollment through completion of follow-up assessments
No study locations are listed for this record.
Plan to share: Undecided — The plan for sharing individual participant data has not yet been finalized. A decision will be made after considering participant consent, confidentiality, institutional policies, and the feasibility of providing access to de-identified data.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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