To determine the comparative effectiveness of cervical translatoric mobilizations with cervical stability training on pain and mobility in female patients with cervicogenic headache.
Design
Randomized controlled trial
Settings and conduct
SETTING:
Orthopedic Department, Mayo Hospital, Lahore.
Neurology Department, Mayo Hospital, Lahore.
Physiotherapy Department, Mayo Hospital, Lahore.
DURATION OF STUDY:
Six months after the approval of synopsis
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Female patients aged 20-40 years
Diagnosis of cervicogenic headache
Positive cervical flexion-rotation test (FRT)
Exclusion Criteria:
Patients previously receiving treatment for underlying pathology.
Patients presented with red flag signs for headache.
Patients presented with migraine.
Patients in whom manual therapy is contraindicated.
Patients who are diagnosed with radiculopathy.
Patients who are taking analgesics.
Intervention groups
GROUP-A: Cervical Translatoric Mobilization
This group will receive a 10-minute treatment consisting of 30-second series of translatoric mobilizations of the upper cervical spine with 10-second rest periods between sets.
GROUP-B: Cervical Stability Training
The Cervical Stability Training consists of three application phases.
The first phase will improve muscular coordination and proprioception.
The second phase will improve muscular endurance and strength.
The final phase will improve muscular strength as well. The intensity of exercise in the third phase will be slightly higher than in the second phase.
Based on the exercise tolerance of the patients, all exercises will be repeated 7–10 times during the first week and 10–15 times during the second week of each phase.
Main outcome variables
Pain reduction
Increasing range of motion
Reduced disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220518054910N1
Registration date:2023-05-31, 1402/03/10
Registration timing:registered_while_recruiting
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Yasham Afzal
Name of organization / entity
King Edward Medical University
Country
Pakistan
Phone
+92 323 7888180
Email address
yashamafzal61@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-15, 1401/12/24
Expected recruitment end date
2023-07-31, 1402/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Cervical Translatoric Mobilizations with Cervical Stability Training in female patients with Cervicogenic Headache
Public title
COMPARISON OF THE EFFECTIVENESS OF CERVICAL TRANSLATORIC MOBILIZATIONS WITH CERVICAL STABILITY TRAINING IN FEMALE PATIENTS WITH CERVICOGENIC HEADACHE: A RANDOMIZED CONTROLLED TRIAL
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The study will include female patients aged 20-40 years.
A diagnosis of cervicogenic headache (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region)
Positive cervical flexion-rotation test (FRT)
Exclusion criteria:
Patients previously receiving treatment for underlying pathology.
Patients presented with red flag signs for headache.
Patients presented with migraine.
Patients in whom manual therapy is contraindicated.
Patients who are diagnosed with radiculopathy.
Patients who are taking analgesics.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
All the participants who came to the physiotherapy department were considered and screened for cervicogenic headache with restricted neck movements. 82 patients were allotted to two groups i.e.; group A(CTM) and group B(CST) via a computer-generated randomized list, 41 in each group. Considered the inclusion and exclusion criteria before concerning them in the study. Informed consent was taken whether they were willing to participate or not in written form.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants were allocated to two treatment groups named A and B. None of the participants know which of the two modes of ultrasound has been used on him/her as both modes require the ultrasound machinery and nothing else. The care provider has been giving treatment according to the protocols decided and he/she has no role in measuring the results. The outcome assessor or the investigator is involved in the outcome measurements of both groups and has no role in applying treatment protocols to the patients or the randomization. The data analyzer is involved in the analysis of data only and has no role in randomization, treatment application, or outcome measurement. None of the members of DSMB are involved in the application of randomization, treatment application, outcome measurement, or data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Parallel groups, single blinded, single setting
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Advanced Studies and Research Board
Street address
Neela Gumbad, New Anarkali, Lahore
City
LAHORE
Postal code
54000
Approval date
2022-04-05, 1401/01/16
Ethics committee reference number
2543/KEMU/2022
Health conditions studied
1
Description of health condition studied
Cervicogenic Headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Pain
Timepoint
Before applying Intervention and at week 3 and week 6 of intervention.
Method of measurement
Visual Analogue Scale
2
Description
Range of Motion (Upper Cervical)
Timepoint
Before applying Intervention and at week 3 and week 6 of intervention.
Method of measurement
Goniometer
3
Description
Range of Motion (General Cervical)
Timepoint
Before applying Intervention and at week 3 and week 6 of intervention.
King Edward Medical University, Mayo Hospital, Lahore Pakistan
Full name of responsible person
Yasham Afzal
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore.
City
Lahore
Postal code
54000
Phone
+92 323 7888180
Email
yashamafzal61@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
King Edward Medical University, Mayo Hospital Lahore
Full name of responsible person
Yasham Afzal
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore
City
Lahore
Postal code
54000
Phone
+92 323 7888180
Email
yashamafzal61@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
King Edward Medical University, Mayo Hospital Lahore
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
King Edward Medical University, Mayo Hospital Lahore
Full name of responsible person
Yasham Afzal
Position
Post Graduate Resident
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 323 7888180
Email
yashamafzal61@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
King Edward Medical University, Mayo Hospital Lahore
Full name of responsible person
Yasham Afzal
Position
Post Graduate Resident
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 323 7888180
Email
yashamafzal61@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
King Edward Medical University, Mayo Hospital Lahore
Full name of responsible person
Yasham Afzal
Position
Post Graduate Resident
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Nila Gumbad Chowk, Neela Gumbad Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 323 7888180
Email
yashamafzal61@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be shared in the form of Excel and Microsoft Word files.
When the data will become available and for how long
6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
The person responsible for data updates will be reviewing requests for data. Data will be shared through email.
From where data/document is obtainable
yashamafzal61@gmail.com
What processes are involved for a request to access data/document
Provide full detail of the reason you want to pursue data from my study. Then wait for a max of one month to receive it if the request for data is approved.