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Comparative effects of SNAG and cervicoscapular strengthening on pain intensity, headache frequency and duration, and quality of life in cervicogenic headache patients.

Protocol summary

Study aim
The aim of the study is to compare the effectiveness of SNAG and cervicoscapular strengthening on pain intensity, headache frequency and duration, and quality of life in patients with cervicogenic headache
Design
Randomized, superiority, parallel-group trial with blinded outcome assessment. Randomization was centralized and computerized with computer-generated random numbers sequence carried out at an external site.
Settings and conduct
participants, healthcare providers who care for participants during the trial, data collectors, outcome assessors, and with lesser importance data safety and monitoring board and manuscript writers. outcome assessor will the blind in the study.
Participants/Inclusion and exclusion criteria
Participants will be added to the study if they are 18 to 45 of age, both male and female, have unilateral headaches without side shift, have positive flexion rotation test, have had headaches for 3 months for a minimum of once per week, and have pain intensity equal or less than 4 on numeric pain rating scale, participants will be excluded from the study if they are suffering from dizziness, any visual problem, or have a congenital problem of the cervical spine.
Intervention groups
Group A: participants in this group will receive SNAG and cervicoscapular strengthening with a hot pack for 5 weeks with 3 sessions per week on alternate days. Group B: participants will receive cervicoscapular strengthening with a hot pack for 5 weeks with 3 sessions per week on alternate days.
Main outcome variables
Numeric pain rating scale, Headache questionnaire sheet, Headache impact test-6.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230720058859N1
Registration date: 2023-08-03, 1402/05/12
Registration timing: registered_while_recruiting

Last update: 2023-08-03, 1402/05/12
Update count: 0
Registration date
2023-08-03, 1402/05/12
Registrant information
Name
Sidrah Murtaza
Name of organization / entity
The University of Lahore, Lahore Pakistan
Country
Pakistan
Phone
+92 300 9449192
Email address
sidrahmurtaza92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-01-23, 1402/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of SNAG and cervicoscapular strengthening on pain intensity, headache frequency and duration, and quality of life in cervicogenic headache patients.
Public title
Comparative effects of SNAG and cervicoscapular strengthening on pain intensity, headache frequency and duration and quality of life in cervicogenic headache patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants of age 18-45 year Both gender Subjects having unilateral headache without side shift Headache for the previous 3 months as a minimum once per week Subjects having positive flexion rotation test Pain intensity equal or more than 4 on numeric pain rating scale
Exclusion criteria:
Participants suffering from dizziness Any visual disturbance Subjects having any congenital condition of cervical spine
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
the sample will be randomly divided into two groups using computer-generated random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
the assessor will be blind in the study, who evaluated the final outcomes at the end of the treatment
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethical committee of the university of Lahore
Street address
1-km defence road near bhuptian chowk Lahore
City
Lahore
Postal code
54000
Approval date
2023-07-18, 1402/04/27
Ethics committee reference number
REC-UOL-455-07-2023

Health conditions studied

1

Description of health condition studied
Cervicogenic headache
ICD-10 code
G44.86
ICD-10 code description
ICD-10 code G44.86 for cervicogenic headache is a medical classification as listed by WHO under the range- diseases of the nervous system.

Primary outcomes

1

Description
Pain intensity
Timepoint
Before treatment and 5 weeks after treatment
Method of measurement
Numeric pain rating scale

2

Description
Headache frequency and duration
Timepoint
Before treatment and 5 weeks after treatment
Method of measurement
Headache questionnaire sheet

3

Description
Quality of life
Timepoint
Before treatment and 5 weeks after treatment
Method of measurement
Headache impact test-6

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A will receive SNAG and cervicoscapular strengthening with the hot pack for 5 weeks with 3 sessions per week on alternate days
Category
Treatment - Other

2

Description
Intervention group: Group B will receive cervicoscapular strengthening with hot pack fro 5 weeks with 3 session per week on alternate days.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The university of lahore teaching hospital
Full name of responsible person
Dr. Sana Tauqeer
Street address
1-km defence road near bhuptian chowk lahore
City
Lahore
Postal code
54000
Phone
+92 324 4294807
Email
sanatauqeer@uipt.uol.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of Lahore
Full name of responsible person
Dr. Sana Tauqeer
Street address
1-km defence road near bhuptian chowk Lahore
City
Lahore
Postal code
54000
Phone
+92 324 4294807
Email
sana.tauqeer@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Lahore
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The university of lahore
Full name of responsible person
Sidrah Murtaza
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road near bhuptian chowk Lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 302 9442292
Email
sidrahmurtaza92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Sana Tauqeer
Position
senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road near bhuptian chowk Lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 324 4294807
Email
sana.tauqeer@uipt.uol.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Sana Tauqeer
Position
senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road near bhuptian chowk Lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 324 4294807
Email
sana.tauqeer@uipt.uol.edu.pk

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
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