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Randomized Controlled Trials of Acupuncture for Chronic Tension-Type Headache

A study on the construction and validation of a clinical indirect comparative effect model for acupuncture based on Bayesian modeling and interpretable machine learning – (Randomized Controlled Trials of Acupuncture for Chronic Tension-Type Headache)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000215
Enrollment
Unknown
Registered
2025-02-06
Start date
2025-02-10
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic tension-type headache (CTTH)

Interventions

Acupuncture group:Acupuncture treatment: Acupuncture was performed 3 times a week for the first 4 weeks and 2 times a week for the last 4 weeks. A total of 20 sessions of acupuncture were received.
Positive drug control group:Oral medication: Amitriptyline hydrochloride tablets. During the first week, the dosage is 12.5 mg/day, increasing by 12.5 mg/day each week as tolerated. By the second week
Placebo acupuncture group:Placebo acupuncture therapy. Acupuncture was performed 3 times a week for the first 4 weeks and 2 times a week for the last 4 weeks. A total of 20 sessions of acupuncture wer

Sponsors

Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for chronic tension-type headache (CTTH) as defined by the 3rd edition of the International Classification of Headache Disorders (ICHD-3); (2) Age between 18 and 65 years (inclusive) applicable to both males and females; (3) Has a history of CTTH for at least 1 year; (4) Experienced headaches for at least 15 days per month over the past 3 months; (5) Has not taken any related treatment medications in the past 3 months; (6) Fully informed of the study and willing to receive acupuncture and oral medication able to comply with the treatment complete the full course and provide complete data; (7) Able to maintain a headache diary; (8) Signed informed consent form by the patient or their immediate family member on their behalf.

Exclusion criteria

Exclusion criteria: (1) Headache may be caused by other conditions (e.g. subarachnoid hemorrhage cerebral hemorrhage cerebral embolism cerebral thrombosis vascular malformations arthritis hypertension or arteriosclerosis); (2) Use of preventive medications within the past 3 months; (3) Presence of severe neurological cardiovascular hepatic or renal diseases or contraindications to the Western medications related to the trial which may prevent the patient from receiving acupuncture or medication treatment; (4) Pregnancy or breastfeeding; (5) Participation in any other clinical trials within the past 3 months or currently participating in other trials that may interfere with this study. Note: Patients meeting any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Response rate at week 12;—

Secondary

MeasureTime frame
headache intensity;Average number of headache days;Visual analogue scale,VAS;Safety outcomes;Acute medication usage;—

Countries

China

Contacts

Public ContactHui Zheng

Chengdu University of Traditional Chinese Medicine

zhenghui@cdutcm.edu.cn18011503380

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026