Migraine, Dysmenorrhea
Conditions
Brief summary
Background: Migraine is common but poorly managed with drugs. Acupuncture, a non-pharmacological approach, has shown promise, yet its mechanisms remain unclear. This study aims to assess the efficacy and specificity of acupuncture for acute paroxysmal migraine without aura. Methods: A randomized, single-blind, sham-controlled trial will recruit 60 patients from Tongji Hospital, China. Patients will receive 20 sessions of Deqi or sham acupuncture over 4 weeks and be followed for 8 weeks. Treatments will occur twice within 4 hours of headache onset. Primary outcome is complete headache remission within 120 minutes after two treatments without analgesics. Secondary outcomes include headache intensity reduction, remission rates, and adverse events. Blind assessment will be conducted after at least one session. Data will be analyzed using full and per-protocol sets. Ethics: Approved by the Clinical Trial Ethics Committee (approval no: TJ-IRB20220573). Written consent will be obtained. Results will be published in a peer-reviewed journal.
Interventions
OTHERreal acupuncture
Real Acupuncture Group Main acupoints: Hegu (bilateral), Taichong (bilateral), Taiyang (unilateral), shuogu (unilateral), Fengchi (unilateral); Positioning: refer to the 2006 national standard of the people's Republic of China (gb/t 12346-2006) acupoint names and positioning Operation method: supine position, skin routine disinfection. The special model of acupuncture and moxibustion (0.30mm × 30mm), fix the gasket on the acupoint skin with seam free tape, and then acupuncture. After acupuncture, each acupoint will be lifted, inserted and twisted three times in small amplitude; The needle will be kept for 30 minutes. During this period, the technique of small amplitude uniform lifting, inserting and twisting (3 times) will be performed every 10 minutes. A total of four times of needling will be performed.
OTHERsham acupuncture
Sham acupuncture group Acupoint selection: select eight stimulation points at the neck and shoulder. Stimulation point 1: the midpoint of the line between the shoulder well and the giant bone (both sides); Stimulation point 2: 5 inches (both sides) of the inferior paraspinal process of the seventh thoracic vertebra; Stimulus point 3: the inferior paraspinal process of the eighth thoracic vertebra will be opened 5 inches (bilateral); Stimulus point 4: 5 inches (both sides) of the infraspinous process of the ninth thoracic vertebra. Positioning: refer to the 2006 national standard of the people's Republic of China (gb/t 12346-2006) acupoint names and positioning to avoid acupoints. Operation method: supine position, skin routine disinfection. Streitberger acupuncture (0. 300×30mm). Fix the gasket on the acupoint skin with seam free tape,and then acupuncture. After acupuncture, each acupoint will be lifted, inserted and twisted three times in small amplitude; The needle will be kept fo
Sponsors
Bo Huang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\\They met the diagnostic criteria of migraine without aura and had a history ofmore than 1 year; 2\\Age 18-65 years old; * 18.5kg/m2 ≤ BMI ≤ 30.0kg / m2,right-handed; ④ The average frequency of migraine attacks in recent 6 months was ≥ 2-8 times per month; The average number of migraine attacks per month in recent 6 months was less than 15 days; The neurological examination was negative, and the CT or MRI of the head was normal; There was no experience of acupuncture or migraine prevention and treatment in recent 3 months; Able to complete the baseline migraine diary; Agree to sign the informed consent form.
Exclusion criteria
* Other types of primary headache or secondary headache; It is complicated with serious primary diseases such as cardiovascular,cerebrovascular, liver, kidney, gastrointestinal, blood, nervous system, etc; Complicated with severe mental illness; In the past 12 weeks, migraine drugs were taken orally or headache treatment methods such as acupuncture and physiotherapy were received; Lactation, pregnant women and planned pregnant women; Participate in another clinical trial at the same time; Illiterate, unable to read comprehension scale; Poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of people with complete remission of migraine | 2 hours |
Countries
China
Outcome results
None listed