Electroacupuncture to reduce medication-overuse headache and explore effects on the central nervous system

Efficacy and Central Mechanism of Electroacupuncture for Medication Overuse Headache: a Multicenter Randomized Controlled Trial

This trial will test whether electroacupuncture can lower the number of headache days and reduce medication use in people with medication-overuse headache.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06802471 on ClinicalTrials.gov

What this trial studies

This randomized, stratified, sham-controlled trial will enroll 120 people with medication-overuse headache and assign them 1:1 to electroacupuncture (EA) or non-penetrating sham electroacupuncture (SEA). The EA group receives 30 treatments over a 12-week period while all participants receive health education and record symptoms in an electronic headache diary. The primary outcome is change in headache days per month at 12 weeks, with additional follow-ups at 4, 8, 24, and 36 weeks and secondary outcomes including medication use, headache severity, disability, and mood. Investigators will also examine central nervous system regulatory effects and perform multi-omics analyses to explore biological mechanisms of EA.

Who should consider this trial

Good fit: Adults meeting ICHD-3 criteria for medication-overuse headache with a history of migraine or tension-type headache ≥12 months, ≥15 headache days/month during screening, good electronic diary adherence, and prior failed withdrawal attempts are the intended participants.

Not a fit: Patients without medication-overuse headache, those who already respond to withdrawal treatment, or those unable to attend frequent acupuncture sessions are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If effective, electroacupuncture could meaningfully reduce monthly headache days and decrease reliance on acute headache medications for people with MOH.

How similar studies have performed: Acupuncture has shown benefit for migraine and tension-type headache in prior trials, but high-quality sham-controlled evidence specifically for MOH is limited and mechanisms remain uncertain.

Eligibility criteria

Inclusion Criteria for Patients with MOH:

* Meet the diagnostic criteria of MOH in ICHD-3;
* A history of migraine (according to ICHD-3 criteria)/tension headache (TTH) (according to ICHD-3 criteria) for ≥12 months before screening;
* Patients entered data from the electronic headache diary for at least 24 of the 28 days of the screening period (evidence of good adherence to the electronic headache diary);
* Prospectively collected data from the electronic headache diary during the screening period met the following criteria: 15 or more headache days per month; Regular overdose of acute or symptomatic headache medications meets the diagnostic criteria for MOH；
* Headache diagnosed before the age of 50 years;
* Patients had failed MOH withdrawal treatment (with medical documentation or specific physician confirmation of each treatment) on ≥1 occasions in the previous 3 years; Withdrawal treatment failure is defined as no significant reduction in headache frequency, duration and/or severity after withdrawal treatment; Or intolerable withdrawal reactions during withdrawal treatment; Or unable to quit treatment due to safety issues;
* Aged between 18 and 80 years old;
* Signed the informed consent and volunteered to participate in the study.
* Patients who met the above 8 criteria were included in this study.

Exclusion Criteria for Patients with MOH:

* Patients had a history or diagnosis of hypotensive headache, continuous hemiplegia, new daily persistent headache, or unusual migraine subtypes, such as hemiplegic migraine (sporadic and familial), ocular tension migraine, migraine with neurologic symptoms that were atypical of migraine aura (diplopia, altered consciousness, or prolonged duration). Other types of primary or secondary headache;
* The presence of clinically significant pain syndromes that may be confusing (e.g., fibromyalgia, chronic low back pain, complex regional pain syndrome); Acute or active temporomandibular joint disorders;
* The patient had an uncontrolled and/or untreated mental illness (e.g., severe depression and schizophrenia) for at least 6 months prior to the screening visit; Patients with a history of psychosis and/or mania within 5 years before screening were excluded;
* The patient has any other medical condition whose treatment takes precedence over MOH treatment or may interfere with the study treatment or impair compliance with treatment;
* Taking/using medications/stimulation devices that may affect headache (e.g., beta-blockers (atenolol, propranolol, metoprolol, etc.) due to headache or other reasons within 3 months before or during the screening period; Calcium channel blockers (flunarizine, benzothiazide, etc.); Antidepressants (amitriptyline, venlafaxine, duloxetine, etc.); Antiepileptic drugs (topiramate, sodium valproate, carbamazepine, etc); Angiotensin-receptor blockers (candesartan and lisinopril); Botulinum toxin; Gabapentin; Noninvasive vagus nerve stimulation, transcranial magnetic stimulation, peripheral trigeminal nerve stimulation; Biofeedback, health products; Occipital nerve block, other nerve block; Continuous infusion therapy, steroid reduction; Chiropractic therapy, physical therapy); Or treatment with injections (trigger point injections, extracranial nerve blocks or facet joint injections) on the head, face or neck;
* The patient has a history of moderate or severe head or neck trauma, or other neurological or systemic diseases (such as epilepsy and dementia) that the researcher believes may affect the central nervous system function;
* Patients have or have had one or more of the following conditions that were considered in the study to be associated with clinical symptoms: other neurological, pulmonary, hepatic, endocrine, gastrointestinal, hematologic, infectious, immunologic, or ocular conditions;
* A history of substance or alcohol abuse (according to DSM-5® criteria) within 24 months prior to the screening visit;
* During the screening or baseline visit, the patient has significant suicide risk (answers "Yes" to question 4 or 5 on the C-SSRS suicide ideation section, or answers "Yes" to any question regarding suicidal behavior at any time during the study on the C-SSRS);
* Prophylactic treatment for headache was received 1 month before the screening visit;
* One month before the screening visit, the patient had participated in a clinical study; Or had taken any medication for headache within the 5 plasma half-lives, whichever was longer, before the screening visit;
* Severe uncontrolled disease such as cancer, uncontrolled cardiovascular disease, severe hepatic and renal insufficiency, or coagulopathy; Women who are pregnant or preparing to become pregnant;
* Having known fear of acupuncture or having received acupuncture treatment within 8 weeks before enrollment;
* In the judgment of the investigators, the patients have diseases or take drugs that may affect the assessment of the safety, tolerability, or efficacy of the trial, or affect the conduct or interpretation of the study.
* Any one of the above items is excluded.

Inclusion Criteria for Patients with episodic migraine(Control group 1):

* According to the ICHD-3 criteria, it met the diagnostic criteria of episodic migraine; With/without tension-type headache;
* Headache days/month ≤6 days at enrollment;
* The number of days/month of using analgesics at enrollment was ≤6 days;
* Age between 18 and 80 years;
* Be able to fill out a headache diary;
* No previous history of drug abuse;
* No obvious comorbidities pain, physical or mental disorders;
* No alcohol or drug addiction;
* No pregnancy, breastfeeding, or plans for pregnancy in the next 12 months;

Inclusion Criteria for Healthy Participants(Control group 2):

* No headache or headache ≤2 days in the past 12 months at enrollment;
* No more than 6 days/month of use of analgesics at enrollment;
* Age between 18 and 80 years;
* No significant comorbidities pain, physical, or mental disorders;
* No organic, functional changes or systemic diseases that could cause headache;
* No history of head or neck trauma;
* No significant abnormalities in blood routine, biochemical tests, coagulation function, or urine routine in the past 12 months prior to enrollment;
* No alcohol or drug addiction;
* No pregnancy, breastfeeding, or plans for pregnancy in the next 12 months.

Nonrandomized patients with MOH:

●Participants who meet the MOH diagnostic criteria and fulfill the inclusion/exclusion criteria but decline randomization will be assigned to the non-randomized electroacupuncture group. These participants will receive electroacupuncture treatment directly, with no restrictions on the number of participants per center.

Where this trial is running

Beijing, Beijing Municipality

• Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang´anmen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Weiming Wang, Ph.D — Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Study coordinator: Weiming Wang, Ph.D

Conditions Medication Overuse Headache; Electroacupuncture