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

NCT02592681 | Unknown

• 1 other identifier: WesternUCanada-acu
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Menstrual Migraine

Keywords

menstrual migraine; acupuncture; acupressure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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 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 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

Study Arms (3)

verum acupuncture

EXPERIMENTAL

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

acupressure

ACTIVE COMPARATOR

Acupressure will be applied on all the corresponding acupoints described in the acupuncture group. Duration of each session will be 15 min.

Procedure: acupressure

control acupuncture

SHAM COMPARATOR

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

Interventions

verum acupuncture PROCEDURE

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).

verum acupuncture

acupressure PROCEDURE

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.

acupressure

control acupuncture PROCEDURE

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.

control acupuncture

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Related Publications (12)

• Alecrim-Andrade J, Maciel-Junior JA, Carne 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.

  PMID: 18209514 BACKGROUND

• Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof 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. doi: 10.1177/0333102411417901. No abstract available.

  PMID: 22384463 BACKGROUND

• 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.

  PMID: 18166116 BACKGROUND

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

  PMID: 10437224 BACKGROUND

• Linde K, Streng A, Jurgens 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. doi: 10.1001/jama.293.17.2118.

  PMID: 15870415 BACKGROUND

• Linde M, Fjell A, Carlsson J, Dahlof 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. doi: 10.1111/j.1468-2982.2004.00803.x.

  PMID: 15606569 BACKGROUND

• 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.

  PMID: 25845225 BACKGROUND

• 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.

  PMID: 26060503 BACKGROUND

• 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. doi: 10.1016/j.ijnurstu.2006.03.021. Epub 2006 Jun 16.

  PMID: 16782102 BACKGROUND

• 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.

  PMID: 20114103 BACKGROUND

• 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. doi: 10.1016/S1474-4422(06)70382-9.

  PMID: 16545747 BACKGROUND

• Yu X, Salmoni A. Comparison of the Prophylactic Effect Between Acupuncture and Acupressure on Menstrual Migraine: Results of a Pilot Study. J Acupunct Meridian Stud. 2018 Oct;11(5):303-314. doi: 10.1016/j.jams.2018.04.003. Epub 2018 Apr 11.

  PMID: 29654841 DERIVED

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Alan W Salmoni, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan W Salmoni, Ph. D

CONTACT

519-661-2111; asalmoni@uwo.ca

Xianmin Yu, M. A.

CONTACT

519-661-2111; xyu295@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 30, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 30, 2015

Record last verified: 2015-10