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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

• 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;

• 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.

Locations
Other Locations
China
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang´anmen Hospital
RECRUITING
Beijing
Contact Information
Primary
Weiming Wang, Ph.D
wangweiming1a1@163.com
+8613426424993
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 160
Treatments
Experimental: elecrtoacupuncture group (EA group)
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.
Sham_comparator: Sham elecrtoacupuncture group (SEA group)
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.
No_intervention: Control group 1(CG 1)
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.
No_intervention: Control group 2(CG 2)
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.
Related Therapeutic Areas
Sponsors
Leads: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

This content was sourced from clinicaltrials.gov