Menstrual MigraineNCT02592681
Comparison of the Prophylactic Effect Between Acupuncture and Acupressure on Menstrual Migraine
A study testing verum acupuncture and acupressure in people with Menstrual Migraine, run by Western University, Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Migraine
- What is being tested?
- verum acupuncture and acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- a cardiac pacemaker;
- metal allergy;
- a severe needle phobia;
- or if they are pregnant or lactating.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Menstrual Migraine
- Being tested
- verum acupuncture, acupressure, control acupuncture
- Keywords
- menstrual migraine, acupuncture, acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verum acupunctureProcedure or surgery
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).
acupressureProcedure or surgery
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 acupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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). Receives: Procedure: control acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
average visual analogue scale (VAS) for pain ranging from 0 (no pain) to 10 (worst pain) per month
Measured: 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
Measured: 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
Measured: 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
the absence from work days or school days and/or classes missed due to menstrual migraine per month
Measured: from the date of admission into this study to the date of completion of this study, assessed up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Menstrual MigraineStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Salmoni, Western University, Canada
- Investigators
- Alan W Salmoni, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592681
- Sponsor's protocol ID
- WesternUCanada-acu
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18209514Tfelt-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.
PubMed 22384463Kong 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.
PubMed 18166116Hu J. Acupuncture treatment of migraine in Germany. J Tradit Chin Med. 1998 Jun;18(2):99-101.
PubMed 10437224Linde 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.
PubMed 15870415Linde 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.
PubMed 15606569Sun 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.
PubMed 25845225Wang 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.
PubMed 26060503Jun 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.
PubMed 16782102Lin 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.
PubMed 20114103Diener 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.
PubMed 16545747Yu 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.
PubMed 29654841
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Prophylactic Effect Between Acupuncture and Acupressure on Menstrual Migraine
- ClinicalTrials.gov ID
- NCT02592681
- Acronym / sponsor ID
- WesternUCanada-acu
- Conditions
- Menstrual Migraine
- Keywords
- menstrual migraine, acupuncture, acupressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| verum acupuncture | Experimental | Procedure: verum acupunctureParticipants 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). |
| acupressure | Active comparator | Procedure: acupressureAcupressure will be applied on all the corresponding acupoints described in the acupuncture group. Duration of each session will be 15 min. |
| control acupuncture | Sham comparator | Procedure: control acupunctureThe 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| verum acupunctureParticipants 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). | Procedure or surgery | verum acupuncture |
| acupressureThe 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. | Procedure or surgery | acupressure |
| control acupunctureThe 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. | Procedure or surgery | control acupuncture |
Primary outcome
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.
5 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Background: PubMed 18209514Alecrim-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.
- Background: PubMed 22384463Tfelt-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.
- Background: PubMed 18166116Kong 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.
- Background: PubMed 10437224Hu J. Acupuncture treatment of migraine in Germany. J Tradit Chin Med. 1998 Jun;18(2):99-101.
- Background: PubMed 15870415Linde 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.
- Background: PubMed 15606569Linde 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.
- Background: PubMed 25845225Sun 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.
- Background: PubMed 26060503Wang 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.
- Background: PubMed 16782102Jun 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.
- Background: PubMed 20114103Lin 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.
- Background: PubMed 16545747Diener 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.
- Derived from this study: PubMed 29654841Yu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan W Salmoni, PhD principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing verum acupuncture and acupressure in people with Menstrual Migraine, run by Western University, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan W Salmoni, Ph. D (519-661-2111 ext. 83541, asalmoni@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02592681, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.