The aim of this study was to evaluate the effect of reflexology trigger points on pain of a migraine headache patients referred to clinic Imam Reza (AS) in Shiraz at 1395. The study in the clinic of Imam Reza (AS), which is affiliated to Shiraz University of Medical Sciences is done in 81 patients with migraine headaches that are eligible to be enrolled in the study after obtaining written informed consent. Initially for 1 month questionnaire to all individuals in terms of intensity, duration and number of headache are frequent. Then people into three groups divided : placebo, control and intervention. Intervention and placebo groups received 8 sessions of massage, each for 20 minutes but did not cause any interference in the control group. During this period, the three groups (2) to fill out the questionnaire. After a month in the intervention and placebo groups will follow.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410278505N13
Registration date:2017-06-06, 1396/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of trigger points reflexology on pain in pathiants with migraine headache
Public title
The Effect of Reflexology on Migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:The age range 20 to 55 year; Diagnosed migraine at least six months after; Diagnosis by Neurologist;At least primary education to health in the legs, especially on the soles of the feet and toes member;Possession and higher average pain severity (based on a numeric scale of pain intensity 3 and and more by criteria NRS); No member of the medical professions of physical (based on self-report or file)
Exclusion criteria: Lack of desire to continue cooperation; Catching to patients with diabetes or a history of arthritis; Having inflammation of peripheral neuropathy, skin ulcer, infection of the lower extremities; Drug addiction, sedatives, alcohol; Risk of clotting problems
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
81
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Blvd، 7 th floor, Shiraz University of Medical Sciences, Shiraz, Iran
City
shiraz
Postal code
713451978
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.SUMS.REC.1396.15
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Severe Of Headache
Timepoint
Before the intervention,Immediately after the start of Massage
Method of measurement
NRS: Numeric Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Previous drug use In addition, foot massage trigger points for 20 minutes, twice a week for 8 sessions.
Category
N/A
2
Description
Placebo: Previous drug use In addition
massage foot ceilings point for 20 minutes, twice a week and for 8 sessions.
Category
N/A
3
Description
Control group: Only eat previous drugs without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Reza
Full name of responsible person
Hasan Arjmand
Street address
clinic of Imam Reza (AS), Namazi Square, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research affairs
Full name of responsible person
Dr Sayed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research affairs
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
Shiraz University of Medical Sciences
Full name of responsible person
Sayed Saeed Najafi
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Hospital, Namazi square, Shiraz
City
Shiraz
Postal code
713451978
Phone
+98 71 3626 7101
Fax
Email
Najafisa@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeed Najafi
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Postal code
713451978
Phone
+98 71 3626 7101
Fax
Email
Najafisa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hasan Arjmand
Position
Mcs of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Namazi square,Namazi Square,Shiraz
City
Shiraz
Postal code
Phone
+98 71 3825 7879
Fax
Email
H_Arjomand2012@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)