Protocol summary

Summary
Cervicogenic headache is related to musculoskeletal structure disorders in cervical region. The aim of this study is to determine the effect of muscle energy techniques on capital rotator muscles thickness and echogenicity (measured by B mode Sonography) and other symptoms of cervicogenic headache (intensity, duration, frequency and disability of headache, which will be measured by questionnaires). This study is a randomized single blinded clinical trial that patients are not aware of grouping. Thirty Subjects with cervicogenic headache will be selected according to the criteria of International Headache Society (headache related with cervical musculoskeletal disorders, upper cervical rotation range of motion restriction and pain and hypomobility in upper cervical region movement and palpation). Selected patients will be divided into two groups with 15 subjects by simple randomization assignment (Flip the coin). In the experiment group treatment intervention will be done by infrared radiation in prone position and muscle energy techniques for extensor and capital rotator muscles in supine position. In the control group only infrared radiation will be used in prone position. Both groups will have six treatment sessions. Before and after of all treatment sessions in two groups thickness and echogenicity of capital rotator muscles in anterior and posterior sides of the upper cervical region will be measured by sonography and upper cervical rotation range of motion by Goniometer. Headache index and headache disability questionnaires will be completed in first and 6th sessions for all subjects.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031421459N1
Registration date: 2016-08-22, 1395/06/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-22, 1395/06/01
Registrant information
Name
Mohammad Akbari
Name of organization / entity
Dept. of Physical therapy, School of Rehabilitation,Iran University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
akbari.mo@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and Technology of Iran University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of muscle energy technique on thickness and echogenicity of capital rotator muscles and components of cervicogenic headache in cervicogenic headache subjects compared with control group: A Randomized Clinical Trial
Public title
The effect of muscle energy technique on Cervicogenic Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: subjects with cervicogenic headache due to at least 3 months, age between 18–55 years and BMI between16–32 kg/m2. Exclusion criteria: Patients with other types of headache, uncorrected visual or auditory impairments, history of exercise therapy, physical therapy or manual therapy for neck and shoulder regions in previous 3 months, pregnancy, problems such as diabetes, cardiopulmonary diseases, myopathy, history of cancer, surgery within the last 3 months , Psychological disorders, Any condition necessitating bed rest for more than two weeks during past 12 months, alcohol consumption, consuming pain reducer medicine within 24 hours before testing.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
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 Iran University of Medical Sciences
Street address
Hemmat Highway, between sheykh fazlollah and Chamran Highways, Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.IUMS.REC 1395.9211342209

Health conditions studied

1

Description of health condition studied
Cervicogenic Headache
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified

Primary outcomes

1

Description
Muscle thickness and echogenicity
Timepoint
After and before intervention session
Method of measurement
Anterior posterior muscle dimension (thickness) and tissue echogenicity that both will be measured by ultrasound machine SAMSUNG MEDISON - SONOACE R7 2014, made in Korea with a frequency of 7.5 and a linear probe in millimeters.

Secondary outcomes

1

Description
Upper Cervical Range of Motion
Timepoint
After and before intervention session
Method of measurement
The rotational range of motion of the neck in the supine position will be measured with a Qoniometer (degree).

2

Description
Headache Index
Timepoint
First and 6th session
Method of measurement
Questionare (Niere,1997)

3

Description
Headache Disability
Timepoint
First and 6th session
Method of measurement
Iranian version of Headache Disability Inventory (HDI) questionare, Jacobson-1994)

Intervention groups

1

Description
Control group: Infrared Radiation in prone position for 15 minutes
Category
Rehabilitation

2

Description
Intervention group: infrared radiation in a prone position for 15 minutes and muscle energy techniques for head extensor and rotator muscles in the supine position, 3 times, each time 5-7 seconds with 30% of maximum contraction
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology and Physioterapy clinics in Tehran
Full name of responsible person
Omolbanin Abaspour
Street address
7 P, Madadkaran Al, Shahnazari St, Madar Sq, Mirdamad Blvd
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research and Technology of Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Hemmat highway, between Chamran and Sheikh Fadlallah highways, Iran University of Medical Sciences, headquarters, 5th floor
City
Tehran
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 and Technology of Iran 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
School of Rehabilitation, Iran University of Medical Sciences.
Full name of responsible person
Omolbanin Abaspour
Position
PhD of PT student
Other areas of specialty/work
Street address
7 p, Madadkaran A, Shahnazari St, Madar Sq, Mirdamad Blvd
City
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
o.abaspour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Dr Mohamad Akbari
Position
Professor PhD of PT
Other areas of specialty/work
Street address
7 P, Madadkaran Al, Shahnazari St, Madar Sq, Mirdamad Blvd
City
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
akbari.mo@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation
Full name of responsible person
Omobanin Abaspour
Position
PT PhD student
Other areas of specialty/work
Street address
7 P, Madadkaran A, Shahnazari St, Madar Sq, Mirdamad Blvd
City
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
o.abaspour@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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