The objestive of this study is assessing the effect of adding acupuncture to conventional migraine prophylaxis. The inclusion criteria is having more than 3 migraine attacks in a month and inadequacy of three months conventional prophylaxis treatment. The exclusion criteria is absence of a net diagnosis for migraine, and being received acupuncture treatment in the past six months.
The study population are patients with migraine who refer to Neurology Clinic of Qaem hospital, Mashhad, Iran. One hundred migraine patients in whom the number of attacks did not drop by 50% after receiving prophylactic medications entered the study. The intervention included True Acupuncture+prophylactic medications in comparison to Sham Acupuncture + prophylactic medications. The Intervention time is one month including 12 sessions of acupuncture treatments every other day. The primary outcome is the number of headache attacks at the baseline, month1, 2,3 and4.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108097265N1
Registration date:2013-07-16, 1392/04/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2011-12-31, 1390/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A sham-controlled trial of acupuncture as an adjunct to migraine prophylaxis
Public title
Acupuncture for migraine prophylaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a diagnosis for Migraine; more than 3 migraine attacks in a month; inadequacy of three months conventional prophylaxis treatment; Patient's consent to receive acupuncture Exclusion criteria: Absence of a net diagnosis for migraine; Patient's disapproval; Patients who did not fulfill their treatment sessions; Migraine headaches which are responsive to medications; Patients who had received acupuncture treatment in the past six months.
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences-Qorashi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2011-02-26, 1389/12/07
Ethics committee reference number
89590
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
the numbers of monthly headache attacks
Timepoint
baseline, and at the end of first month treatment, at the end of the second, third and fourth months from baseline
Method of measurement
patients' self-report of monthly headache frequency
Secondary outcomes
empty
Intervention groups
1
Description
Intervention-True Acupuncture: Inserting needles on true acupoints and maintaining them for 30 minutes in each treatment session, 3 times per week, duration: one month.
Category
Treatment - Other
2
Description
Control- Sham Acupuncture: inserting needles superficially not in real acupuncture points and maintaining them for 30 minutes in each session, 3 times per week, duration: one month.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic, Qaem Hospital
Full name of responsible person
Mohsen Kalhor, Mohsen Foroughipour
Street address
Ahmadabad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi (Vice Chancellor for research)/ Dr. Mahyar Mirheydari
Street address
Qorashi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Integrative Medicine, Beijing University of Chinese Medicine
Full name of responsible person
Amir Reza Golchian
Position
lecturer
Other areas of specialty/work
Street address
Department of Integrative Medicine, Beijing University of Chinese Medicine
City
Beijing
Province
Beijing
Postal code
Phone
00861064286426
Fax
Email
amirgol67@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Foroughipour
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Neurology, Faculty of Medicine, Qaem Hospital
City
Mashhad
Postal code
Phone
+98 108400001
Fax
Email
ForoughipourM@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Chinese and Complementary Medicine, School of Traditional and Complementary Medicine,
Full name of responsible person
Hoda Azizi
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Traditional and Complementary Medicine, East Razi Street
City
Mashhad
Postal code
Phone
+98 51 1852 0282
Fax
Email
azizih@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)