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Comparison of the Prophylactic Effect Between Acupuncture and Acupressure on Menstrual Migraine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Alan Salmoni, Western University, Canada.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02592681
First Posted: October 30, 2015
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alan Salmoni, Western University, Canada
  Purpose
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.

Condition Intervention
Menstrual Migraine Procedure: verum acupuncture Procedure: acupressure Procedure: control acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Prophylactic Effect Between Acupuncture and Acupressure on Menstrual Migraine

Resource links provided by NLM:


Further study details as provided by Alan Salmoni, Western University, Canada:

Primary Outcome Measures:
  • change from baseline menstrual migraine attack frequency at 9 months [ Time Frame: 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.


Secondary Outcome Measures:
  • change from baseline number of migraine days at 9 months [ Time Frame: from the date of admission into this study to the date of completion of this study, assessed up to 9 months ]
  • change from baseline average visual analogue scale (VAS) at 9 months [ Time Frame: from the date of admission into this study to the date of completion of this study, assessed up to 9 months ]
    average visual analogue scale (VAS) for pain ranging from 0 (no pain) to 10 (worst pain) per month

  • change from baseline total duration period of pain (hours) at 9 months [ Time Frame: 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 [ Time Frame: 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 the absence from work days or school days and/or classes missed at 9 months [ Time Frame: from the date of admission into this study to the date of completion of this study, assessed up to 9 months ]
    the absence from work days or school days and/or classes missed due to menstrual migraine per month


Estimated Enrollment: 120
Study Start Date: November 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Procedure: verum acupuncture
Participants will receive real needle insertion. Sterile needles 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. 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). Extra acupoints will be selected based on TCM pattern are GB41 (Zulinqi), SP10 (Xuehai), KI3 (Taixi), or LR2 (Xingjian).
Active Comparator: acupressure
Acupressure will be applied on all the corresponding acupoints described in the acupuncture group. Duration of each session will be 15 min.
Procedure: acupressure
The acupoints and the number of the sessions will be exactly the same as for the verum acupuncture group. Acupressure will be applied on all the corresponding acupoints described in the acupuncture group. Finger pressure will be applied to each acupoint for eight seconds followed by two-seconds rest, repeated for 3 min. The strength of the pressure depends on individual participant's sensation of "de-qi". Duration of each session will be 15 min.
Sham Comparator: 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).
Procedure: control acupuncture
The number, duration, and frequency of the sessions will be the same as for the verum acupuncture group. Sterile needles will be used on acupoints that have no therapeutic effect on either menstruation or migraines, based on the acupuncture text books and acupuncture research literature. The points chosen will be: LR7 (Xiguan), GB35 (Yangjiao), LI12 (Zhouliao), M-BW-1 (Dingchuan). The depth of needle insertion will be as superficial as 3 mm, and without manual rotation, in order to minimize stimulation of the needle.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. females aged from 18 to 40;
  2. a diagnosis of pure menstrual migraine or menstrually related migraine according to the criteria of the International Classification of Headache Disorders III beta version;
  3. regular menstrual periods;
  4. repeated self-considered MM attacks of at least half a year;
  5. no plan to become pregnant or change hormonal treatment during the study; and
  6. voluntarily joining this study and providing informed consent.

Exclusion Criteria:

  1. difficulties in differentiating migraine from other types of headaches;
  2. other primary headaches such as tension-type headache and cluster headache, and secondary headache;
  3. lack of time and/or motivation to participate;
  4. starting in use of any new kind of migraine prophylactic drugs in the last three months;
  5. serious cardiovascular, neurological, or psychiatric diseases according to self-reported medical history;
  6. severe bleeding disorder or anticoagulation according to the medical history;
  7. a cardiac pacemaker;
  8. metal allergy;
  9. a severe needle phobia;
  10. or if they are pregnant or lactating.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592681


Contacts
Contact: Alan W Salmoni, Ph. D 519-661-2111 ext 83541 asalmoni@uwo.ca
Contact: Xianmin Yu, M. A. 519-661-2111 ext 80224 xyu295@uwo.ca

Sponsors and Collaborators
Western University, Canada
Investigators
Principal Investigator: Alan W Salmoni, PhD Western University
  More Information

Publications:

Responsible Party: Alan Salmoni, Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT02592681     History of Changes
Other Study ID Numbers: WesternUCanada-acu
First Submitted: October 27, 2015
First Posted: October 30, 2015
Last Update Posted: October 30, 2015
Last Verified: October 2015

Keywords provided by Alan Salmoni, Western University, Canada:
menstrual migraine
acupuncture
acupressure

Additional relevant MeSH terms:
Migraine Disorders
Premenstrual Syndrome
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Menstruation Disturbances
Pathologic Processes