Fibromyalgia (FM)NCT07835516
Electroconvulsive Therapy for Refractory Fibromyalgia
A study testing Electroconvulsive Therapy and Standard medical treatment in people with Fibromyalgia (FM), run by Beijing Tiantan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- Electroconvulsive Therapy and Standard medical treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Availability to receive 4 weeks of ECT immediately after inclusion or after a 16-week waiting period, and availability for a 3-month follow-up visit after completion of all ECT sessions.
- Sufficient cognitive and language skills to comply with all study requirements.
Who cannot join
- 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.
- History of ECT within the previous 6 months or previous nonresponse to ECT.
- Concomitant presence of other painful medical conditions in addition to fibromyalgia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Electroconvulsive Therapy for Refractory Fibromyalgia: a Multicenter, Prospective, Randomized, Open-labelled, Wait-list Controlled 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia (FM)
- Being tested
- Electroconvulsive Therapy, Standard medical treatment
- Keywords
- refractory fibromyalgia, electroconvulsive therapy, Neuromodulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive TherapyProcedure or surgery
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 treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Wait-list Control With Usual Standard Treatment | Active comparator | 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. Receives: Drug: Standard medical treatment |
| Immediate Bilateral Electroconvulsive Therapy | Active comparator | 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. Receives: Procedure: Electroconvulsive Therapy; Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month after completion of the initial 4-week ECT treatment
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment through completion of follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835516
- Sponsor's protocol ID
- KY2026-185
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroconvulsive Therapy for Refractory Fibromyalgia: a Multicenter, Prospective, Randomized, Open-labelled, Wait-list Controlled Trial
- ClinicalTrials.gov ID
- NCT07835516
- Acronym / sponsor ID
- KY2026-185
- Conditions
- Fibromyalgia (FM)
- Keywords
- refractory fibromyalgia, electroconvulsive therapy, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-list Control With Usual Standard Treatment | Active comparator | Drug: Standard medical treatmentParticipants 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. |
| Immediate Bilateral Electroconvulsive Therapy | Active comparator | Procedure: Electroconvulsive Therapy, Drug: Standard medical treatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Availability to receive 4 weeks of ECT immediately after inclusion or after a 16-week waiting period, and availability for a 3-month follow-up visit after completion of all ECT sessions.
Key exclusion criteria (6 listed)
- 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.
- History of ECT within the previous 6 months or previous nonresponse to ECT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive TherapyParticipants 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. | Procedure or surgery | Immediate Bilateral Electroconvulsive Therapy |
| Standard medical treatmentParticipants 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. | Drug | Immediate Bilateral Electroconvulsive Therapy, Wait-list Control With Usual Standard Treatment |
Primary outcome
Change in Average Pain Intensity From Baseline to 1 Month After Completion of the Initial 4-Week Treatment
Time frame: Baseline and 1 month after completion of the initial 4-week ECT 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.
9 secondary outcomes
Average Pain Intensity During the Randomized Controlled Phase
Time frame: 3 days, 2 weeks, and 3 months after completion of the initial 4-week ECT treatment period
Fibromyalgia-related Functional Impairment
Time frame: 3 days, 2 weeks, 1 month, and 3 months after completion of the initial 4-week ECT treatment period
Sleep Quality
Time frame: 3 days, 2 weeks, 1 month, and 3 months after completion of the initial 4-week ECT treatment period
Depressive Symptoms
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
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
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
Time frame: 3 days, 2 weeks, 1 month, and 3 months after completion of the delayed 4-week ECT treatment course
Cognitive function measures
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
Time frame: From enrollment through completion of follow-up assessments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Luo principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive Therapy and Standard medical treatment in people with Fibromyalgia (FM), run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo, Doctor (13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Pain Intensity From Baseline to 1 Month After Completion of the Initial 4-Week Treatment (time frame: Baseline and 1 month after completion of the initial 4-week ECT treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.