Objectives: A comparison between therapeutic efficacy of temper reform and wet-cupping in patients with migraine headache. Design: The type of research was randomized controlled clinical trial. The samples were 55 patients for each group. Target based sampling was done. Samples' migraine headache confirmed by the neurologist. For randomization, researcher created groups with 3 patients and then gets in per groups by lot. Method: After determining the temper in first group, temper reforming was performed by traditional physician. Wet-cupping was performed in three stages within two weeks for the second group. It was not performed anything for control group. Pain measurement was done by Mac Gill scale before intervention and every 2 weeks until 30 days for all three groups. Inclusion criteria: age>12; confirm the diagnosis by the neurologist. Exclusion criteria: become pregnant (females); malignancy; current treatment with other complementary treatments. In total, 55 patients age>12 years with migraine headache were selected for each group. Interventions: wet-cupping for cupping group and temper reform for the other group was done. Drug therapy continued base on neurologist's order for patients and researcher did not have any changing in drug therapy and only recorded there. Researcher did wet-cupping (3 times with 2 weeks interval) and for the other group did temper reform, in addition drug therapy. Outcomes assessed at baseline and again 42 days after started intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110314495N2
Registration date:2013-06-26, 1392/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-26, 1392/04/05
Registrant information
Name
Mohammad Zarei
Name of organization / entity
Islamic Azad University Quchan Branch
Country
Iran (Islamic Republic of)
Phone
+98 58 1220 1210
Email address
m.zarei@iauq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Islamic Azad University, Quchan Branch
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between therapeutic efficacy of temper reform and wet-cupping in patients with migraine headache
Public title
Temper reform and wet-cupping in migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age> 12; confirm the diagnosis by the neurologist. Exclusion criteria: become pregnant (females); malignancy; treated with other complementary treatments
Age
From 13 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Islamic Azad University, Quchan Branch
Street address
Islamic Azad University, Quchan Branch
City
Quchan
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
52061901202001
Health conditions studied
1
Description of health condition studied
Migraine Headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
migraine headache
Timepoint
Before intervention and every 2 weeks until 42 days after intervention
Method of measurement
Scale of Mac Gill
Secondary outcomes
empty
Intervention groups
1
Description
Drug therapy and wet-cupping were done. Drug therapy continued base on neurologist's order for patient and researcher had any changing in drug therapy and only recorded them. Wet-cupping will be applied in 3 stages: between the two scapulas; each wet-cupping treatment procedure will last about 20 min and will be conducted in 3 steps.
Category
Other
2
Description
Drug therapy and temper reform were done. Drug therapy continued base on neurologist's order for patient and researcher had any changing in drug therapy and only recorded them. Temper reform was done by the specific diet for each temperament.
Category
Other
3
Description
Drug therapy was done. Drug therapy continued base on neurologist's order for patient and researcher had any changing in drug therapy and only recorded them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of cupping in Quchan
Full name of responsible person
Dr. Seyed Ali Javadi
Street address
Davoodi St., Imam St.
City
Quchan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University, Quchan Branch
Full name of responsible person
Hamid Tabatabaee Yazdi
Street address
Islamic Azad University, Quchan Branch
City
Quchan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University, Quchan Branch
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
Islamic Azad University, Quchan Branch
Full name of responsible person
Amir Tabatabaee
Position
MSN
Other areas of specialty/work
Street address
Nursing Department, Islamic Azad University, Quchan Branch
City
Quchan
Postal code
Phone
+98 51 1726 2676
Fax
+98 58 1223 5031
Email
tabatabaei.amir@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Quchan Branch
Full name of responsible person
Mohammad Zarei
Position
MSN
Other areas of specialty/work
Street address
No.177, Hafez 5
City
Quchan
Postal code
9471636581
Phone
+98 58 1220 1210
Fax
+98 58 1223 5031
Email
m.zarei51@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Quchan Branch
Full name of responsible person
Mohammad Zarei
Position
MSN
Other areas of specialty/work
Street address
No.177, Hafez 5
City
Quchan
Postal code
9471636581
Phone
+98 58 1220 1210
Fax
+98 58 1223 5031
Email
m.zarei51@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)