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Tests treatment safety and results for Medication Overuse Headache
Official title Efficacy and Central Mechanisms of Electroacupuncture for Medication Overuse Headache
ClinicalTrials.gov ID: NCT06802471
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Prospectively collected data from the electronic headache diary during the screening period met the following criteria: 15 or more headache days per...
You likely can't join if
- for Patients with MOH:
- Patients had a history or diagnosis of hypotensive headache, continuous hemiplegia, new daily persistent headache, or unusual migraine subtypes, such...
- The presence of clinically significant pain syndromes that may be confusing (e.g., fibromyalgia, chronic low back pain, complex regional pain...
- The patient had an uncontrolled and/or untreated mental illness (e.g., severe depression and schizophrenia) for at least 6 months prior to the...
- The patient has any other medical condition whose treatment takes precedence over MOH treatment or may interfere with the study treatment or impair...
- Taking/using medications/stimulation devices that may affect headache (e.g., beta-blockers (atenolol, propranolol, metoprolol, etc.) due to headache...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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, side effects, or how well it works of the trial, or affect the conduct or interpretation of...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.