Actively Recruiting
Efficacy and Central Mechanism of Electroacupuncture for Medication Overuse Headache: a Multicenter Randomized Controlled Trial
Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2025-07-16
160
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying medication overuse headache (MOH), a condition where frequent use of headache medication can worsen headache symptoms. This clinical trial aims to evaluate how electroacupuncture compares to sham electroacupuncture for MOH and to explore how electroacupuncture affects brain mechanisms related to this condition. The study includes analyses using brain imaging and multi-omics methods to better understand the treatment effects. The trial is randomized and sham-controlled, with 120 participants assigned to either an electroacupuncture group or a sham electroacupuncture group. Electroacupuncture involves 30 treatment sessions over 12 weeks, with sessions three times a week for six weeks and then twice a week for six weeks. Both groups receive health education on lifestyle, behavioral therapies, and MOH self-management. Two additional control groups include patients with episodic migraine and healthy volunteers, matched by age and gender, who undergo assessments and brain MRI scans without acupuncture treatment. Participants will be closely monitored through headache diaries, questionnaires, and brain scans at multiple time points up to 36 weeks after treatment. If electroacupuncture shows benefits, a second follow-up phase will continue for up to three years to track headache recurrence, medication use, and quality of life. The study measures include changes in headache frequency, duration, severity, medication use, anxiety, depression, and overall impact. Safety and adherence are monitored throughout the study.
CONDITIONS
Brief Title
Efficacy and Central Mechanisms of Electroacupuncture for Medication Overuse Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria of medication overuse headache according to ICHD-3
- History of migraine or tension-type headache for at least 12 months before screening
- Completed electronic headache diary for at least 24 of 28 days during screening
- Have 15 or more headache days per month and regular overuse of headache medications
- Headache diagnosed before age 50
- Failed medication overuse headache withdrawal treatment at least once in past 3 years
- Aged between 18 and 80 years
- Signed informed consent and volunteered to participate
- For episodic migraine control: diagnosis per ICHD-3, headache days/month ≤6, analgesic use ≤6 days/month, age 18-80, able to keep headache diary, no drug abuse history
- For healthy controls: no or minimal headaches, analgesic use ≤6 days/month, age 18-80, no significant pain or mental disorders, no history of head or neck trauma
- Nonrandomized patients with MOH who decline randomization may receive electroacupuncture without restriction
You will not qualify if you...
- History of unusual or secondary types of headache such as hypotensive headache or hemiplegic migraine
- Presence of significant pain syndromes like fibromyalgia or active temporomandibular joint disorders
- Untreated or uncontrolled mental illness including recent severe depression or psychosis
- Medical conditions that interfere with treatment or compliance
- Use of medications or devices affecting headache within 3 months before screening
- History of moderate or severe head or neck trauma or neurological diseases affecting the central nervous system
- Other systemic diseases linked to clinical symptoms
- Substance or alcohol abuse within 24 months prior to screening
- Significant suicide risk during screening
- Use of prophylactic headache treatment within 1 month before screening
- Participation in another clinical trial or recent medication use for headache
- Severe uncontrolled diseases such as cancer or severe cardiovascular disease
- Pregnancy, breastfeeding, or planning pregnancy
- Known fear of acupuncture or acupuncture treatment within 8 weeks before enrollment
- Any condition affecting safety, tolerability, or study assessment as judged by investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants complete an electronic headache diary for at least 24 of 28 days during screening.
Duration - 12 weeks
Participants receive electroacupuncture or sham electroacupuncture treatments alongside health education and usual care for medication overuse headache. Treatment includes 30 sessions over 12 weeks, with 3 sessions per week for the first 6 weeks and 2 sessions per week for the next 6 weeks.
3 sessions per week for 6 weeks, then 2 sessions per week for 6 weeks, each session lasting about 30 minutes
Duration - Up to 36 weeks
Participants are followed for up to 36 weeks after treatment to monitor headache frequency, medication use, and other health outcomes. Assessments include headache diaries, clinical evaluations, and questionnaires.
Follow-up assessments at weeks 24 and 36 after treatment
Duration - Up to 3 years after treatment
Participants who complete the initial study and consent to continue will be monitored at 1, 2, and 3 years after treatment to assess headache recurrence, medication use, and quality of life measures.
Assessments at 1, 2, and 3 years post-treatment
Trial Site Locations
Total: 1 location
1
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang´anmen Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
W
Weiming Wang, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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