studying the effect of myofascial release on cervical ROM and myofascial elasticity in cervicogenic patients, and also studies the effect of application of myofascial release in lumbar region on cervical region
Design
clinical trial with parallel groups
Settings and conduct
Myofascial release is a manual therapy technique which is focused on fascial elasticity by applying compressive and tensile forces. the place of this study is in the shahid bahonar hospital in the city of kerman
Participants/Inclusion and exclusion criteria
cervicogenic headache patients with the age between 20 and 50 and myofascial tissue stiffer than normal group; diagnosis of other types of headaches and application of physical therapy at recent 6 months
Intervention groups
1- application of myofascial release on cervical region 2- application of myofascial release on lumbar region
Main outcome variables
coefficient of elastic. range of motion of the neck, intensity of the pain, quality of life, range of motion of the lumbar region, the amount of forward head, the amount of inclination of the pelvis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190221042794N1
Registration date:2019-07-18, 1398/04/27
Registration timing:prospective
Last update:2019-07-18, 1398/04/27
Update count:0
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
Mahdi Tavakkoli
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3824
Email address
mtavakkoli@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of lumbar and cervical myofascial release on flexibility, pain and quality of life in cervicogenic headache patients
Public title
effect of myofascial release on cervicogenic headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20 and 30 years
suffering from CGH based on the diagnosis of specialized doctor according to ICHD-2018-3
the tragus at least 2/5 centimeter at the anterior of vertical line
the amount of lumbar flexion lesser than 35 degrees
headache at least once a week in recent 2 months
based on VAS the intensity of headache should be at least 5
BMI between 18 to 24 and 24 to 30
the elastic coefficient of the cervical region should be higher than the normal group
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
non informing the patient the groups and their intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of tarbiat modares university of tehran
Street address
No. 9, Shahid Shirvani Ave., jomhuri Eslami Blvd.
City
Kerman
Province
Kerman
Postal code
7618937773
Approval date
2019-01-27, 1397/11/07
Ethics committee reference number
IR.Modares.Rec.1397.238
Health conditions studied
1
Description of health condition studied
cervicogenic headache
ICD-10 code
G44.89
ICD-10 code description
Other headache syndrome
Primary outcomes
1
Description
Elastic Coeffecient
Timepoint
2 weeks before the intervention, before the intervention, after the intervention
Method of measurement
sonography apparatus
Secondary outcomes
1
Description
cervical range of motion
Timepoint
2 weeks before the intervention, before the intervention, after the intervention
Method of measurement
goniometer
2
Description
intensity of the pain
Timepoint
2 weeks before the intervention, before the intervention, after the intervention
Method of measurement
visual analogue scale
3
Description
quality of life
Timepoint
2 weeks before the intervention, before the intervention, after the intervention, 4 weeks after the intervention
Method of measurement
Headache Impact Test with 6 questions (HIT6)
4
Description
range of motion of lumbar flexion
Timepoint
2 weeks before the intervention, before the intervention, after the intervention
Method of measurement
flexible ruler
5
Description
amount of forward head
Timepoint
2 weeks before the intervention, before the intervention, after the intervention
Method of measurement
ruler
6
Description
amount of inclination of the pelvis
Timepoint
2 weeks before the intervention, before the intervention, after the interventio
Method of measurement
goniometer
Intervention groups
1
Description
Intervention group: myofascial release of lumbar region
Category
Rehabilitation
2
Description
Intervention group: myofascial release of cervical region
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar hospital
Full name of responsible person
Farid Bahrpeyma
Street address
Sepah Ave.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mahdi_tavakkoli817@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
tarbiat modares university
Full name of responsible person
yaaghub fathollahi
Street address
Jalal AleAhmad, Nasr bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 82880
Email
pres@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
tarbiat modares university
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
tarbiat modares university
Full name of responsible person
farid bahrpeyma
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalale ale ahmad, Nas Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 82880
Email
bahrpeyf@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
tarbiat modares university
Full name of responsible person
farid bahrpeyma
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalale ale ahmad, Nas Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 82880
Email
bahrpeyf@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Mahdi Tavakkoli
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jalal al ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3824
Fax
Email
m_tavakkoli@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available