Comparison of the Prophylactic Effect Between Acupuncture and Acupressure on Menstrual Migraine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- change from baseline menstrual migraine attack frequency at 9 months
研究概览
简要总结
This study is designed to make comparisons between acupuncture and acupressure for preventing menstrual migraine (MM). Whether acupuncture is superior to acupressure is the most interesting point of this study. First of all, females will be screened for eligibility. Then, all participants who meet the inclusion criteria will be asked to keep a headache migraine diary for three months as baseline data. The diaries will then be collected before the first treatment. Then, all the participants will receive the corresponding interventions on the eighth, fifth and second days before the estimated first day of menstruation (determined individually from the diaries) in each month for three months (menstrual cycle), making a total of nine treatment sessions. After the whole treatments, there will be a three-month follow-up period. All the participants will be asked to complete the headache diaries every month from baseline to the end of the study. The diaries recording data from the fourth to the ninth month will then be collected at the end of the ninth month for the second time indicating the end of the study for the participants. In case of an acute migraine attack, participants will not be restricted from using "normal" medications.
详细描述
First of all, the females who are interested in this study will have an appointment with the researcher to decide their eligibility according to the inclusion and exclusion criteria. If eligible, participants will then sign a consent form.
Then, all participants who meet the inclusion criteria will be asked to keep a headache diary in which they will record the date of any migraine attacks, starting and ending time point of each migraine attack, drug usage (doses and type), average migraine pain on a 10-point VAS, and days of menstruation, during a three-month period (three menstrual cycles). The diaries will be collected by the researcher at the end of the third month and the traditional Chinese medicine (TCM) patterns of MM of the participants will be diagnosed then according to answering a few symptom related questions. In addition, times/dates for treatments will be scheduled.
Upon arrival at the exercise lab, Room 4115 inside Thames Hall in Western University on the first treatment day (the eighth day before the estimated first day of menstruation), participants will be asked to sit and relax for 1-2 min. Then they will be asked to lie down in a prone position receive corresponding interventions by the acupuncturist.
In the verum acupuncture group, participants will receive real needle insertion. Sterile needles (0.18 mm in diameter and 30 mm in length, DONGBANG Needle, Korea) will be used on all acupoints. The depth of insertion will vary from 15 mm to 20 mm depending on the exact locations. An initial manual stimulation will be given at insertion by rotation methods to produce a specific sensation described as "de-qi" in TCM (a sensation perceived by the acupuncture receivers as numbness, fullness, and sometimes soreness around the point. Then the needles will be left in the acupoint for 20 min, with a manual rotation at 4-8 Hz and an amplitude of approximately 0.5-2 rotations at a ten-min interval to maintain the sensation of "de-qi".
Primary acupoints used in the verum acupuncture group will be: LR3 (Taichong), LI4 (Hegu), SP6 (Sanyinjiao), GB20 (Fengchi). They are selected according to several previous relevant clinical studies. Extra acupoints will be selected based on TCM pattern. If it is due to qi stagnation, GB41 (Zulinqi) will be added. If it is due to blood stasis, SP10 (Xuehai) will be added. If it is due to Liver and Kidney yin deficiency, KI3 (Taixi) will be added. If it is due to Liver fire, LR2 (Xingjian) will be added. The exact localizations of these acupoints are described in a textbook. All these points will be applied bilaterally unless there are explicit reasons for not doing so being described in details.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •females aged from 18 to 40;
- •a diagnosis of pure menstrual migraine or menstrually related migraine according to the criteria of the International Classification of Headache Disorders III beta version;
- •regular menstrual periods;
- •repeated self-considered MM attacks of at least half a year;
- •no plan to become pregnant or change hormonal treatment during the study; and
- •voluntarily joining this study and providing informed consent.
排除标准
- •difficulties in differentiating migraine from other types of headaches;
- •other primary headaches such as tension-type headache and cluster headache, and secondary headache;
- •lack of time and/or motivation to participate;
- •starting in use of any new kind of migraine prophylactic drugs in the last three months;
- •serious cardiovascular, neurological, or psychiatric diseases according to self-reported medical history;
- •severe bleeding disorder or anticoagulation according to the medical history;
- •a cardiac pacemaker;
- •metal allergy;
- •a severe needle phobia;
- •or if they are pregnant or lactating.
研究组 & 干预措施
verum acupuncture
Participants will receive real needle insertion. The needles will be left in the acupoint for 20 min, with a manual rotation at a ten-min interval. Primary acupoints used in the verum acupuncture group will be: LR3 (Taichong), LI4 (Hegu), SP6 (Sanyinjiao), GB20 (Fengchi). Extra acupoints will be selected based on TCM pattern are GB41 (Zulinqi), SP10 (Xuehai), KI3 (Taixi), or LR2 (Xingjian).
干预措施: verum acupuncture (Procedure)
acupressure
Acupressure will be applied on all the corresponding acupoints described in the acupuncture group. Duration of each session will be 15 min.
干预措施: acupressure (Procedure)
control acupuncture
The number, duration, and frequency of the sessions will be the same as for the verum acupuncture group. The points chosen will be: LR7 (Xiguan), GB35 (Yangjiao), LI12 (Zhouliao), M-BW-1 (Dingchuan).
干预措施: control acupuncture (Procedure)
结局指标
主要结局
change from baseline menstrual migraine attack frequency at 9 months
时间窗: from the date of admission into this study to the date of completion of this study, assessed up to 9 months
Once the patient is free of headache for 48 hours, a new attack will be considered another headache.
次要结局
- change from baseline average visual analogue scale (VAS) at 9 months(from the date of admission into this study to the date of completion of this study, assessed up to 9 months)
- change from baseline total duration period of pain (hours) at 9 months(from the date of admission into this study to the date of completion of this study, assessed up to 9 months)
- change from baseline number of days with analgesic medication at 9 months(per month, from the date of admission into this study to the date of completion of this study, assessed up to 9 months)
- change from baseline number of migraine days at 9 months(from the date of admission into this study to the date of completion of this study, assessed up to 9 months)
- change from baseline the absence from work days or school days and/or classes missed at 9 months(from the date of admission into this study to the date of completion of this study, assessed up to 9 months)
研究者
Alan Salmoni
Professor
Western University, Canada