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

Menstrual Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02592681
• Other study ID #: WesternUCanada-acu
• Status: Not yet recruiting
• Phase: N/A
• First received: October 27, 2015
• Last updated: October 28, 2015
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2015
• Source: Western University, Canada
• Contact: Alan W Salmoni, Ph. D
• Phone: 519-661-2111
• Email: asalmoni[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

In the acupressure group 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.

In the control acupuncture group, the number, duration, and frequency of the sessions will be the same as for the verum acupuncture group. Sterile needles (0.18 mm in diameter and 15 mm in length, DONGBANG Needle, Korea) 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.

All interventions will be performed by the same acupuncturist licensed by the College of Traditional Chinese Medicine Practitioners and Acupuncturists of Ontario (CTCMPAO). Before the acupuncture treatment, appropriate infection control measures will be employed, and different size of single use, sterile, disposable needles in appropriate packages will be available. Participants will be suggested to wear shorts and T-shirts to the lab for their treatments. They will assume a prone position. The skin over points will be swabbed with 70% ethyl alcohol, using an outward rotary motion from the center of the point to the surrounding area to lessen the risk of contamination. No treatment will be taken until the alcohol dries. The acupuncturist will wash his hands immediately before the removal of needles. On withdrawing a needle, a sterile cotton ball will be used to press the skin at the insertion site. If blood is drawn, light pressure will be applied with a clean swab.

The second and third treatment will be on the fifth and third day before the estimated first day of menstruation in each month. The whole process will be repeated at total of nine times over the three months of treatment.

Sample size is calculated from one relatively well designed study. According to this study, the migraine attack frequency each month after treatment in the verum acupuncture group was 4.8 ± 3.8 times, and in the sham acupuncture group 7.8 ± 3.7 times. Based on a power of 0.8 to detect a significant difference (α = .05, two-sided), 32 participants will be required for each group, which is calculated by R software Version 0.96.122 (RStudio, Boston, MA). Allowing for a 20% withdrawal rate, a total of 120 participants will be enrolled with 40 participants in each group.

The analysis will be started once 10 participants have been collected in each group. The statistical significance level will be set at p = .05, and all statistical tests will be two-sided. Factorial analysis of variance (ANOVA) will be used to make comparisons among the three groups. Tukey's post hoc test will be used then to analyze the outcomes of each pair of two groups at each time point. Comparisons within groups for the outcomes at each time point will be done using the one-way ANOVA. All the analyses will be performed using R software Version 0.96.122.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Menstrual Migraine
• Migraine Disorders

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

References & Publications (11)

Alecrim-Andrade J, Maciel-Júnior JA, Carnè X, Severino Vasconcelos GM, Correa-Filho HR. Acupuncture in migraine prevention: a randomized sham controlled study with 6-months posttreatment follow-up. Clin J Pain. 2008 Feb;24(2):98-105. doi: 10.1097/AJP.0b013e3181590d66. — View Citation

Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A, Tegenthoff M, Trampisch HJ, Zenz M, Meinert R; GERAC Migraine Study Group. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol. 2006 Apr;5(4):310-6. Erratum in: Lancet Neurol. 2008 Jun;7(6):475. — View Citation

Hu J. Acupuncture treatment of migraine in Germany. J Tradit Chin Med. 1998 Jun;18(2):99-101. — View Citation

Jun EM, Chang S, Kang DH, Kim S. Effects of acupressure on dysmenorrhea and skin temperature changes in college students: a non-randomized controlled trial. Int J Nurs Stud. 2007 Aug;44(6):973-81. Epub 2006 Jun 16. — View Citation

Kong J, Gollub R, Huang T, Polich G, Napadow V, Hui K, Vangel M, Rosen B, Kaptchuk TJ. Acupuncture de qi, from qualitative history to quantitative measurement. J Altern Complement Med. 2007 Dec;13(10):1059-70. doi: 10.1089/acm.2007.0524. Review. — View Citation

Lin JA, Wong CS, Lee MS, Ko SC, Chan SM, Chen JJ, Chen TL. Successful treatment of primary dysmenorrhea by collateral meridian acupressure therapy. J Manipulative Physiol Ther. 2010 Jan;33(1):70-5. doi: 10.1016/j.jmpt.2009.11.003. — View Citation

Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005 May 4;293(17):2118-25. — View Citation

Linde M, Fjell A, Carlsson J, Dahlöf C. Role of the needling per se in acupuncture as prophylaxis for menstrually related migraine: a randomized placebo-controlled study. Cephalalgia. 2005 Jan;25(1):41-7. — View Citation

Sun LH, Li XH, Li WL, Liu L, Ma HL, Liang YL. [Body acupuncture combined with auricular acupressure for menstrual headache: a randomized controlled clinical trial]. Zhen Ci Yan Jiu. 2015 Feb;40(1):70-4. Chinese. — View Citation

Tfelt-Hansen P, Pascual J, Ramadan N, Dahlöf C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. — View Citation

Wang Y, Xue CC, Helme R, Da Costa C, Zheng Z. Acupuncture for Frequent Migraine: A Randomized, Patient/Assessor Blinded, Controlled Trial with One-Year Follow-Up. Evid Based Complement Alternat Med. 2015;2015:920353. doi: 10.1155/2015/920353. Epub 2015 Apr 28. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline menstrual migraine attack frequency at 9 months	Once the patient is free of headache for 48 hours, a new attack will be considered another headache.	from the date of admission into this study to the date of completion of this study, assessed up to 9 months	No
Secondary	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	No
Secondary	change from baseline average visual analogue scale (VAS) at 9 months	average visual analogue scale (VAS) for pain ranging from 0 (no pain) to 10 (worst pain) per month	from the date of admission into this study to the date of completion of this study, assessed up to 9 months	No
Secondary	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	No
Secondary	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	No
Secondary	change from baseline the absence from work days or school days and/or classes missed at 9 months	the absence from work days or school days and/or classes missed due to menstrual migraine per month	from the date of admission into this study to the date of completion of this study, assessed up to 9 months	No