Condition: Headache, Migraine · Sponsor: Taichung Veterans General Hospital
Aims: To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination. Methods: In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep. In addition, patients' characteristics will be investigated as follows: 1. Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure) 2. Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle) 3. Anxiety, evaluate …
This description comes directly from the study's public registry record.
Yuan-Chen Liu, M.D. · 886-972199271 · jordan810701@gmail.com
Ching-Chun Chung, M.D. · 886-988566621 · gracechung1015@gmail.com
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| Taichung Veterans General Hospital | Taichung, Taichang, Taiwan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06584409