Comparison of the effect of joint mobilization and exercise on pain, range of motion and cervical motor control in patients with chronic cervicogenic headache
Comparison of the effect of joint mobilization and exercise on pain, range of motion and cervical motor control in patients with chronic cervicogenic headache
Design
The study is an experimental, interventional, and clinical trial type.
Settings and conduct
This study was conducted in Yazd in volunteer patients with cervicogenic headache.
Participants/Inclusion and exclusion criteria
Entry Criteria:
1) Ladies and gentlemen aged 18-45 years
2) Having at least 3 months of headache history
3) Having at least one headache per week
4) At least 5 criteria of CHISG
5) Positive test of upper three cervical intervertebral movements
6) Not receiveing physiotherapy and / or chiropractic treatment at least a year ago
7) No signs of degeneration, radiculopathy, progressive rheumatologic and neurological diseases, long history of corticosteroid therapy, history of accident and wiplash injury, malignancy, pregnancy and depression
Intervention groups
The study consists of two groups of exercises therapy and a group of upper cervical mobilization.
Main outcome variables
Headache parameters
Active cervical range of motion
upper cervical rotation range of motion
Craniocervical motor control
Headache disability index questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040466N1
Registration date:2018-12-24, 1397/10/03
Registration timing:retrospective
Last update:2018-12-24, 1397/10/03
Update count:0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
Fateme Ghiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6708
Email address
f_ghiasi_p@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-05, 1397/05/14
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of joint mobilization and exercise on pain, range of motion and cervical motor control in patients with chronic cervicogenic headache
Public title
Effect of physiotherapy in treatment of cervicogenic headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of headache at least 3 months
Headache frequency at least one per week
At least 5 criteria of CHISG
Positive test of upper three cervical intervertebral movements
Not receiving of physiotherapy/ chiropractic treatment at least one year ago
Exclusion criteria:
Test Positive test for cervical Vertebral Artery and ligaments health
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are divided into two groups by the method of two-way random blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are considered blind regardless of the difference in treatment methods of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi street, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.ZAUMS.REC.1397.162
Health conditions studied
1
Description of health condition studied
cervicogenic headache
ICD-10 code
G44.8
ICD-10 code description
Other specified headache syndromes
Primary outcomes
1
Description
pain intensity
Timepoint
The beginning of treatment, session 6 and 12, one month after the end of treatment
Method of measurement
Average pain based on VAS in last week
2
Description
pain ferquency
Timepoint
The beginning of treatment, session 6 and 12, one month after the end of treatment
Method of measurement
The number of days a person has had a headache last week.
3
Description
pain duration
Timepoint
The beginning of treatment, session 6 and 12, one month after the end of treatment
Method of measurement
average hours pain lasted in past week
4
Description
active cervical ROM
Timepoint
The beginning of treatment, session 6 and 12, one month after the end of treatment
Method of measurement
Active motion of the neck in the flexion, extension, lateral flexion and right and left rotation, measured by the motion analysis device.
5
Description
upper cervical rotation ROM
Timepoint
The beginning of treatment, session 6 and 12, one month after the end of treatment
Method of measurement
flexion rotation test angle, which is measured by the motion analyzer.
6
Description
craniocervical motor control
Timepoint
The beginning of treatment, session 6 and 12, one month after the end of treatment
Method of measurement
The numerical value of the pressure biofeedback in the craniocervical flexion test
7
Description
headache disability index
Timepoint
The beginning of treatment, session 6 and 12, one month after the end of treatment
Method of measurement
questionnaire score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: exercise therapy,The patient will perform exercises for 12 sessions to strengthen the muscles of the area.
Category
Rehabilitation
2
Description
Intervention group: mobilization, The Maitland mobilization techniques will be performed on the patient for 12 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Physiotherapy
Full name of responsible person
Mahsa Zakerzadeh
Street address
Mohaghegh Damad
City
Yazd
Province
Yazd
Postal code
8916834718
Phone
+98 35 3824 5881
Email
mah.zaker@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Bakhshani
Street address
Zahedan University of Medical Sciences,Dr.Hesabi sq.,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
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
Zahedan University of Medical Sciences
Full name of responsible person
Mahsa Zakerzadeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mohaghegh Damad 8, Shariati physiotherapy
City
YAZD
Province
Yazd
Postal code
9816834718
Phone
+98 35 3824 5881
Email
mah.zaker@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahsa Zakerzadeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mohaghegh Damad 8, Sariati physiotherapy
City
yazd
Province
Yazd
Postal code
8916834718
Phone
+98 35 3824 5881
Email
mah.zaker@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahsa Zakerzadeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
mohaghegh damad 8, Shariaty physiotherapy
City
YAZD
Province
Yazd
Postal code
9816834718
Phone
+98 35 3824 5881
Email
mah.zaker@gmail.com
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