Medication Overuse HeadacheNCT06802471
Efficacy and Central Mechanisms of Electroacupuncture for Medication Overuse Headache
A study testing electroacupuncture in people with Medication Overuse Headache and Electroacupuncture, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Overuse Headache, Electroacupuncture
- What is being tested?
- electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to Jun 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang´anmen Hospital
Beijing, Beijing Municipality
Xinkun Liu, +8613876859860, liuxinkunleo@qq.com
About this study
Official title: Efficacy and Central Mechanism of Electroacupuncture for Medication Overuse Headache: a Multicenter Randomized Controlled Trial
Acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. However, studies on acupuncture for medication overuse headache (MOH) are limited, and current research has not been able to determine whether its efficacy is due to the actual therapeutic effects of acupuncture or psychological benefits. To address this issue, the investigators have designed a clinical trial to evaluate the efficacy of acupuncture for MOH. In addition, the investigators will explore the regulatory effects of electroacupuncture on central mechanisms in MOH and conduct multi-omics analysis.
Read the detailed description
This is a multicenter, stratified, randomized, sham-controlled clinical trial. 120 eligible participants will be randomly allocated into electroacupuncture (EA), sham electroacupuncture (SEA), in a 1:1 ratio, which was divided into two phases
Phase 1 :
- The EA group will receive 30 electroacupuncture treatments over an 12-week period, while the SEA group will receive sham electroacupuncture treatments with non-penetrating needling.
The two control groups are matched to the MOH patient group by gender and age for recruitment when the planned MOH patient enrollment was nearly 80% complete, and 20 patients in each group will be included, for a total of 40 patients.
Health education will be provided to participants in each group. The primary outcomes will be the changes of headache days per month from baseline after 12 weeks of treatment; The secondary outcomes will be as follows: The change from baseline in the number of headache days per month was also evaluated after 4 weeks of treatment, 8 weeks of treatment, 24 weeks of follow-up, and 36 weeks of follow-up; The proportion of responders, Headache Days per month, average daily headache time, headache Severity, average daily moderate-to-severe headache days, average daily moderate-to-severe headache time, Days with acute medication, Doses taken monthly, Severity of Dependence Scale, Headache Impact Test, EQOL-5D-5L, Hospital Anxiety and Depression Scale, Patients'expectation of the acupuncture efficacy, The Patient Global Impression of Change, The patient blinding assessment, Brain MRI Data Analysis and Multi-omics Analysis; The central randomization and data collection will be conducted by an electronic data management system.
Phase 2:
participants who adhere to the study protocol and complete the Week 36 follow-up will be considered to have completed the study. If the results of the first-phase trial demonstrate that electroacupuncture is superior to the control group, and the participants' willingness is confirmed, those willing to proceed will undergo the second-phase follow-up.
The second phase of follow-up was conducted at 1, 2, and 3 years after the end of treatment.These included whether the participant was lost to follow-up, headache diary (including headache frequency and medication use), recurrence of MOH, new comorbidities, and assessments using SDS, HIT-6, HADS, PGIC, and EQ-5D-5L.
- Conditions
- Medication Overuse Headache, Electroacupuncture
- Being tested
- electroacupuncture, Sham electroacupuncture
- Medical subject headings
- Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
The supine position, the local skin of the acupoints was routinely sterilized, and the selected acupoints were pasted with Acupuncture auxiliary device.
The main acupuncture points are DU20, bilateral EX-HN5, ST8, GB20, GB20, LI4, LR3, ST40.
Select compatible acupoints based on the patient's accompanying symptoms: 1.Discomfort in the neck: EX-B2 of Cervical 3-4; 2.Emotional anxiety, depression or sleep disorders: GV29, HT7; 3.Stomach or abdominal discomfort: CV12, ST25 and CV6.
The disposable acupuncture needles and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China.The specifications of acupuncture needles are Φ0.30×25mm, Φ0.30×40mm, Φ0.30×50mm. The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.
Sham electroacupunctureDevice
The SEA group will use Hua Tuo brand disposable non-insertive sham control needles (Φ0.3mm×40mm) and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China. Sham points 1-2, 3-4, 5-6, and 7-8 are bilaterally located at the midpoints between the following pairs of acupoints: SP19 and EX-UE12, SP6 and LR5, EX-UE1 and HT1, and HT7 and SI8. sham LI4: Bilateral of midpoint between acupoint LI4 and LU9; sham LR3: Bilateral of midpoint between acupoint LR3 and ST44; sham ST40: Bilateral of midpoint between acupoint ST40 and GB35. Compatible acupoints: EX-B2 of Cervical 3-4 horizontal side by 0.5 cun; sham GV29: midpoint between acupoint GV29 and BL2. sham CV12: midpoint between acupoint CV12 and ST21; sham ST25: Bilateral of midpoint between acupoint ST25 and SP15; sham CV6: 3 cun lateral to the level of the CV6; The width of the interphalangeal joint of the patient's thumb was 1 "cun".
| Study group | Role | What they receive |
|---|---|---|
| elecrtoacupuncture group (EA group) | Experimental | Participants will be treated by electroacupuncture. They will be treated 3 sessions a week for the first 6 weeks and 2 sessions a week (once every 2-3 days) for the next 6 weeks. The total course of treatment was 30 times for 12 weeks, each electroacupuncture treatment session for patients will be 30 minutes in duration. All the participants will be accepted usual care:
Health education is provided in three aspects: lifestyle changes, behavioral therapies and MOH self-management.
Basic treatment: Throughout the study period, patients could continue to use their previously overused symptomatic medications as usual. MOH patients are required not to change the type, single dose, or formulation of acute medications. However, they are allowed to increase or decrease the frequency or total amount of use based on their pain condition. Any use of new medications must be accurately documented. Receives: Device: electroacupuncture |
| Sham elecrtoacupuncture group (SEA group) | Sham comparator | Participants will be treated by sham elecrtoacupuncture. They will be treated 3 sessions a week for the first 6 weeks and 2 sessions a week (once every 2-3 days) for the next 6 weeks. The total course of treatment was 30 times for 12 weeks, each electroacupuncture treatment session for patients will be 30 minutes in duration. All the participants will be accepted usual care:
Health education is provided in three aspects: lifestyle changes, behavioral therapies and MOH self-management.
Basic treatment: Throughout the study period, patients could continue to use their previously overused symptomatic medications as usual. MOH patients are required not to change the type, single dose, or formulation of acute medications. However, they are allowed to increase or decrease the frequency or total amount of use based on their pain condition. Any use of new medications must be accurately documented. Receives: Device: Sham electroacupuncture |
| Control group 1（CG 1） | No intervention | Control group consisted of episodic migraine , they were matched to the MOH patient group by gender and age. Participants will undergo a clinical interview once a month, complete the headache diary assessment, have counseling and health education, and rescue medication if necessary. Health education is provided in three aspects: lifestyle changes, behavioral therapies and episodic migraine self-management. Participants will undergo brain MRI scans at baseline and at the end of week 12. Additionally, EA treatment and other interventions or treatments were not allowed throughout the 12-week study period. |
| Control group 2（CG 2） | No intervention | Control group 2 consisted of Healthy Volunteers , they were matched to the MOH patient group by gender and age. Participants will undergo brain MRI scans at baseline and at the end of week 12. Additionally, EA treatment and other interventions or treatments were not allowed throughout the 12-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of headache days
Change from baseline in headache days per month
Measured: At the end of week 12 after randomization.
Secondary outcomes (22)
Change in the number of headache days
Change from baseline in headache days per month
Measured: At the end of week 4, week 8 after randomization; at week 24, week 36 of the follow-up period,
The proportion of responders
The proportion of patients with at least a 50% reduction from baseline in headache days per month and no overuse of acute pain medications
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in headache days per month
The proportion of patients with at least 50% reduction in headache days per month from baseline
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in mean daily headache duration
The changes from baseline in mean daily headache duration
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in mean daily headache duration
The proportion of patients with at least 50% reduction in mean daily headache duration from baseline
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in headache severity score per month
The changes from baseline in headache severity score per month.
Headache severity is recorded daily on a 0-3 scale:
0 = No pain, 1 = Mild pain (does not interfere with activities), 2 = Moderate pain (interferes with some but not all activities), 3 = Severe pain (stops all activities) The monthly headache severity is calculated as the sum of the highest daily headache severity for each day in that month.
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in headache severity score per month
The proportion of patients with at least 50% reduction in headache severity score per month from baseline.
Headache severity is recorded daily on a 0-3 scale:
0 = No pain, 1 = Mild pain (does not interfere with activities), 2 = Moderate pain (interferes with some but not all activities), 3 = Severe pain (stops all activities) The monthly headache severity is calculated as the sum of the highest daily headache severity for each day in that month.
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in the number of moderate and severe headache days per month
The changes from baseline in the number of moderate and severe headache days per month
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in the number of moderate and severe headache days per month
The proportion of patients with at least 50% reduction in the number of moderate and severe headache days per month
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in mean daily duration of moderate and severe headache
The changes from baseline in mean daily duration of moderate and severe headache
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in mean daily duration of moderate and severe headache
The proportion of patients with at least 50% reduction in mean daily duration of moderate and severe headache
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in number of days per month with acute medication for headache
The changes from baseline in number of days per month with acute medication for headache
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in number of days per month with acute medication for headache
The proportion of patients with at least 50% reduction in number of days per month with acute medication for headache
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in total number of doses taken per month for headache
The changes from baseline in total number of doses taken per month for headache
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in total number of doses taken per month for headache
The proportion of patients with at least 50% reduction in total number of doses taken per month for headache
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Severity of Dependence Scale (SDS)
The changes from baseline in the scores of Severity of Dependence Scale (SDS). The original SDS consists of five items, each scored on a scale from 0 to 3. A score of 0 indicates "never or almost never," whereas a score of 3 indicates "always or almost always." The psychological dependence score is based on the first four items of the SDS, with a maximum possible score of 12, higher scores indicate a greater level of dependence. The fifth item concerns the treatment process and is not related to the baseline.
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Hospital Anxiety and Depression Scale (HADS)
The changes from baseline in the scores of Hospital Anxiety and Depression Scale (HADS).
The HADS is used to assess anxiety and depression symptoms experienced over the past week. It consists of 14 items divided into two subscales (7 items each for anxiety and depression), with each item scored from 0 (no symptom) to 3 (severe symptom). Each subscale has a maximum score of 21, and higher scores indicate more severe symptoms. A score of ≥8 is defined as the presence of depression or anxiety.
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Headache Impact Test (HIT-6)
The changes from baseline in the scores of Headache Impact Test (HIT-6). The HIT-6 is a brief tool for assessing the impact of headaches in clinical research and practice. It covers multiple domains of health-related quality of life, including pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. Each of the six items is rated on a 5-point Likert scale (6 = Never, 8 = Rarely, 10 = Sometimes, 11 = Very Often, 13 = Always). The total HIT-6 score is the sum of these six item scores and ranges from 36 to 78. Higher scores indicate a greater impact of headaches.
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Patient Global Impression of Change (PGIC)
The changes in the scores of The Patient Global Impression of Change (PGIC). The PGIC is used to assess the participant's subjective evaluation of overall improvement. The scale consists of seven levels:1 = Very much improved, 2 = Much improved, 3 = Somewhat improved, 4 = No change, 5 = Somewhat worse 6 = Much worse, 7 = Very much worse. Lower scores indicate greater improvement.
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in five-level version of EQ-5D (EQOL-5D-5L)
The changes from baseline in the five-level version of EQ-5D (EQOL-5D-5L).
The EQ-5D-5L comprises two parts:
1.EQ-5D Descriptive System:
This system measures health status across five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Each dimension has five levels, rated from 1 to 5:
1 = No problems/difficulty/discomfort, 2 = Slight problems/difficulty/discomfort 3 = Moderate problems/difficulty/discomfort, 4 = Severe problems/difficulty/discomfort, 5 = Extreme problems/difficulty/discomfort 2.EQ-5D Visual Analog Scale (VAS): This is a 20 cm vertical scale ranging from 0 to 100: 0 represents the "worst imaginable health", 100 represents the "best imaginable health". Higher scores on the VAS indicate better overall health status.
This study uses the validated Chinese version of the EQ-5D-5L, which has demonstrated good reliability and validity.
Measured: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Patients'expectation of the acupuncture efficacy
Participants are asked, "Do you think your medication overuse headache (MOH) improved after completing acupuncture treatment?" They select one of the following five responses: 1.Significantly improved, 2.Very much improved, 3.Some improvement, 4.No improvement at all, 5.Unclear.
Lower-number responses (1 or 2) reflect greater perceived improvement compared with higher-number responses.
Measured: At baseline
The patient blinding assessment
participants are informed that there are two acupuncture therapies: conventional electroacupuncture and micro-electroacupuncture. Both therapies are effective, and in both cases, participants may or may not feel electrical stimulation. They are then asked whether they would accept conventional electroacupuncture. The answer options are: Difficult to distinguish Yes No
Measured: Within 5 minutes after the completion of any week 12 treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Overuse HeadacheStudies 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
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, weiming wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Weiming Wang, Ph.D, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802471
- Sponsor's protocol ID
- 2024-045-KY
- Status last verified
- Sep 2026
- First submitted
- 21 Jan 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data are available on reasonable request. You can send e-mail to us if you have any question
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Central Mechanism of Electroacupuncture for Medication Overuse Headache: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06802471
- Acronym / sponsor ID
- 2024-045-KY
- Conditions
- Medication Overuse Headache, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 31 Jan 2025 (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.
Acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. However, studies on acupuncture for medication overuse headache (MOH) are limited, and current research has not been able to determine whether its efficacy is due to the actual therapeutic effects of acupuncture or psychological benefits. To address this issue, the investigators have designed a clinical trial to evaluate the efficacy of acupuncture for MOH. In addition, the investigators will explore the regulatory effects of electroacupuncture on central mechanisms in MOH and conduct multi-omics analysis.
Detailed description
This is a multicenter, stratified, randomized, sham-controlled clinical trial. 120 eligible participants will be randomly allocated into electroacupuncture (EA), sham electroacupuncture (SEA), in a 1:1 ratio, which was divided into two phases
Phase 1 :
- The EA group will receive 30 electroacupuncture treatments over an 12-week period, while the SEA group will receive sham electroacupuncture treatments with non-penetrating needling.
The two control groups are matched to the MOH patient group by gender and age for recruitment when the planned MOH patient enrollment was nearly 80% complete, and 20 patients in each group will be included, for a total of 40 patients.
Health education will be provided to participants in each group. The primary outcomes will be the changes of headache days per month from baseline after 12 weeks of treatment; The secondary outcomes will be as follows: The change from baseline in the number of headache days per month was also evaluated after 4 weeks of treatment, 8 weeks of treatment, 24 weeks of follow-up, and 36 weeks of follow-up; The proportion of responders, Headache Days per month, average daily headache time, headache Severity, average daily moderate-to-severe headache days, average daily moderate-to-severe headache time, Days with acute medication, Doses taken monthly, Severity of Dependence Scale, Headache Impact Test, EQOL-5D-5L, Hospital Anxiety and Depression Scale, Patients'expectation of the acupuncture efficacy, The Patient Global Impression of Change, The patient blinding assessment, Brain MRI Data Analysis and Multi-omics Analysis; The central randomization and data collection will be conducted by an electronic data management system.
Phase 2:
participants who adhere to the study protocol and complete the Week 36 follow-up will be considered to have completed the study. If the results of the first-phase trial demonstrate that electroacupuncture is superior to the control group, and the participants' willingness is confirmed, those willing to proceed will undergo the second-phase follow-up.
The second phase of follow-up was conducted at 1, 2, and 3 years after the end of treatment.These included whether the participant was lost to follow-up, headache diary (including headache frequency and medication use), recurrence of MOH, new comorbidities, and assessments using SDS, HIT-6, HADS, PGIC, and EQ-5D-5L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| elecrtoacupuncture group (EA group) | Experimental | Device: electroacupunctureParticipants will be treated by electroacupuncture. They will be treated 3 sessions a week for the first 6 weeks and 2 sessions a week (once every 2-3 days) for the next 6 weeks. The total course of treatment was 30 times for 12 weeks, each electroacupuncture treatment session for patients will be 30 minutes in duration. All the participants will be accepted usual care: Health education is provided in three aspects: lifestyle changes, behavioral therapies and MOH self-management. Basic treatment: Throughout the study period, patients could continue to use their previously overused symptomatic medications as usual. MOH patients are required not to change the type, single dose, or formulation of acute medications. However, they are allowed to increase or decrease the frequency or total amount of use based on their pain condition. Any use of new medications must be accurately documented. |
| Sham elecrtoacupuncture group (SEA group) | Sham comparator | Device: Sham electroacupunctureParticipants will be treated by sham elecrtoacupuncture. They will be treated 3 sessions a week for the first 6 weeks and 2 sessions a week (once every 2-3 days) for the next 6 weeks. The total course of treatment was 30 times for 12 weeks, each electroacupuncture treatment session for patients will be 30 minutes in duration. All the participants will be accepted usual care: Health education is provided in three aspects: lifestyle changes, behavioral therapies and MOH self-management. Basic treatment: Throughout the study period, patients could continue to use their previously overused symptomatic medications as usual. MOH patients are required not to change the type, single dose, or formulation of acute medications. However, they are allowed to increase or decrease the frequency or total amount of use based on their pain condition. Any use of new medications must be accurately documented. |
| Control group 1（CG 1） | No intervention | –Control group consisted of episodic migraine , they were matched to the MOH patient group by gender and age. Participants will undergo a clinical interview once a month, complete the headache diary assessment, have counseling and health education, and rescue medication if necessary. Health education is provided in three aspects: lifestyle changes, behavioral therapies and episodic migraine self-management. Participants will undergo brain MRI scans at baseline and at the end of week 12. Additionally, EA treatment and other interventions or treatments were not allowed throughout the 12-week study period. |
| Control group 2（CG 2） | No intervention | –Control group 2 consisted of Healthy Volunteers , they were matched to the MOH patient group by gender and age. Participants will undergo brain MRI scans at baseline and at the end of week 12. Additionally, EA treatment and other interventions or treatments were not allowed throughout the 12-week study period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (37 listed)
- 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;
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 |
|---|---|---|
| electroacupunctureThe supine position, the local skin of the acupoints was routinely sterilized, and the selected acupoints were pasted with Acupuncture auxiliary device. The main acupuncture points are DU20, bilateral EX-HN5, ST8, GB20, GB20, LI4, LR3, ST40. Select compatible acupoints based on the patient's accompanying symptoms: 1.Discomfort in the neck: EX-B2 of Cervical 3-4; 2.Emotional anxiety, depression or sleep disorders: GV29, HT7; 3.Stomach or abdominal discomfort: CV12, ST25 and CV6. The disposable acupuncture needles and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China.The specifications of acupuncture needles are Φ0.30×25mm, Φ0.30×40mm, Φ0.30×50mm. The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi. | Device | elecrtoacupuncture group (EA group) |
| Sham electroacupunctureThe SEA group will use Hua Tuo brand disposable non-insertive sham control needles (Φ0.3mm×40mm) and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China. Sham points 1-2, 3-4, 5-6, and 7-8 are bilaterally located at the midpoints between the following pairs of acupoints: SP19 and EX-UE12, SP6 and LR5, EX-UE1 and HT1, and HT7 and SI8. sham LI4: Bilateral of midpoint between acupoint LI4 and LU9; sham LR3: Bilateral of midpoint between acupoint LR3 and ST44; sham ST40: Bilateral of midpoint between acupoint ST40 and GB35. Compatible acupoints: EX-B2 of Cervical 3-4 horizontal side by 0.5 cun; sham GV29: midpoint between acupoint GV29 and BL2. sham CV12: midpoint between acupoint CV12 and ST21; sham ST25: Bilateral of midpoint between acupoint ST25 and SP15; sham CV6: 3 cun lateral to the level of the CV6; The width of the interphalangeal joint of the patient's thumb was 1 "cun". | Device | Sham elecrtoacupuncture group (SEA group) |
Primary outcome
Change in the number of headache days
Time frame: At the end of week 12 after randomization.
Change from baseline in headache days per month
22 secondary outcomes
Change in the number of headache days
Time frame: At the end of week 4, week 8 after randomization; at week 24, week 36 of the follow-up period,
The proportion of responders
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in headache days per month
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in mean daily headache duration
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in mean daily headache duration
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in headache severity score per month
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in headache severity score per month
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in the number of moderate and severe headache days per month
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in the number of moderate and severe headache days per month
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in mean daily duration of moderate and severe headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in mean daily duration of moderate and severe headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in number of days per month with acute medication for headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in number of days per month with acute medication for headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in total number of doses taken per month for headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in total number of doses taken per month for headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Severity of Dependence Scale (SDS)
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Headache Impact Test (HIT-6)
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Patient Global Impression of Change (PGIC)
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in five-level version of EQ-5D (EQOL-5D-5L)
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Patients'expectation of the acupuncture efficacy
Time frame: At baseline
The patient blinding assessment
Time frame: Within 5 minutes after the completion of any week 12 treatment session
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data are available on reasonable request. You can send e-mail to us if you have any question
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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.
Weiming Wang, Ph.D principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Medication Overuse Headache and Electroacupuncture, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 9 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Weiming Wang, Ph.D (+8613426424993, wangweiming1a1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of headache days (time frame: At the end of week 12 after randomization.). 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 10 Sep 2026.