Protocol summary

Study aim
The purpose of the current study will be to assess the impact of cervical traction and MST on pain, functional disability and grip strength in subjects suffering from cervical radiculopathy.
Design
It is a randomized controlled trial with double blinding of subjects. Data will be collected for 6-9 months after approval
Settings and conduct
Data will be collected from Physical therapy department of Ibn e siena Hospital, Multan
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA Both male and female individuals aged 30-50 years, Individuals with upper-limb pain that had been radiating from their neck for more than three weeks, The clinical prediction rule will be used to diagnose the participants which includes four elements out of which, presence of three elements confirm Cervical Radiculopathy diagnosis. EXCLUSION CRITERIA History of previous cervical or thoracic spine injury, Recent fracture or surgery in and around the shoulder, Any systemic disease, Any comorbid factors, Pregnancy
Intervention groups
Patients will be randomly allocated to two groups Patients in both groups will receive conventional therapy. Group A will be treated with cervical traction. Group B will be treated with Myokinetic Stretching technique, which consists of active and passive stretches with myofascial release (MFR)
Main outcome variables
Pain and functional disability

General information

Reason for update
Acronym
MST
IRCT registration information
IRCT registration number: IRCT20240513061771N1
Registration date: 2024-07-21, 1403/04/31
Registration timing: registered_while_recruiting

Last update: 2024-07-21, 1403/04/31
Update count: 0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
Iraj Shoaib
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 332 5004605
Email address
irajshoaib5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-12, 1402/09/21
Expected recruitment end date
2024-08-12, 1403/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of cervical traction versus myokinetic stretching technique (MST) on pain, functional disability and grip strength in patients with cervical radiculopathy
Public title
comparison of myokinetic stretching technique (MST) and cervical traction on cervical radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Individuals with upper-limb pain that had been radiating from their neck for more than three weeks will be studied. • The clinical prediction rule will be used to diagnose the participants which includes four elements out of which, presence of three elements confirm Cervical Radiculopathy diagnosis. It includes,1.The Spurling test 2.The distraction test 3.The upper limb tension test 4.The ipsilateral cervical rotation less than 60 degrees • Neck disability score <50%
Exclusion criteria:
• History of previous cervical or thoracic spine injury • Recent fracture or surgery in and around the shoulder • Any systemic disease • Any comorbid factors such as congenital, malignant, autoimmune, and neurological conditions involving cervical spine and head • Pregnancy
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Computer generated random number will be used to randomize subjects into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
It will be a double blinded study in which participant and accessor will be unaware of the treatment patient will be receiving.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of The University of Lahore
Street address
1 km Defence Road, near Bhuptian Chowk, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
REC-UOL-653-01-2024

Health conditions studied

1

Description of health condition studied
Cervical Radiculopathy
ICD-10 code
M54.12
ICD-10 code description
Radiculopathy, cervical region

Primary outcomes

1

Description
pain, functional disability
Timepoint
before intervention and 3 weeks after intervention
Method of measurement
Visual analog scale, neck disability index

Secondary outcomes

1

Description
Grip strength
Timepoint
Before intervention and 3 weeks after intervention
Method of measurement
Hand dynamometer

Intervention groups

1

Description
Intervention group 1: Myokinetic Stretching Technique
Category
Rehabilitation

2

Description
Intervention group 2: Cervical Traction
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical therapy department of Ibn e siena Hospital, Multan..
Full name of responsible person
Dr. Sajid Rashid
Street address
Southern Bypass Jahangirabad, Multan
City
Multan
Postal code
60000
Phone
+92 331 7157977
Email
info@ibn-e-siena.org.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Prof. Dr. Ashfaq Ahmed
Street address
1 km Defence Road, near Bhuptian Chowk, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
info@uol.edu.pk
Web page address
https://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
100
Public or private sector
Private
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
The University of Lahore
Full name of responsible person
Iraj Shoaib
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Chaudhary House near New generation school, Zaid town, Piran ghaib road, Multan
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 332 5004605
Email
irajshoaib5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr Arooj Fatima
Position
Head of Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence Road, near Bhuptian Chowk, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 341 4391882
Email
irajshoaib5@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Iraj Shoaib
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Chaudhary House near New Generation school, zaid town, piran ghaib road, Multan
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 332 5004605
Email
irajshoaib5@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Data related to final outcome will be shared by maintaining confidentiality
When the data will become available and for how long
Data will be available starting six months after the publication
To whom data/document is available
Dr. Arooj Fatima ( corresponding author ) HOD at The University of Lahore
Under which criteria data/document could be used
For research purpose
From where data/document is obtainable
To the co-author of the study Dr. Arooj Fatima can be contacted on 03414391882. Also on the search engine, you can find my study at https://scholar.google.com/
What processes are involved for a request to access data/document
Open access and there is traditional public data release where anyone can get access to the data without any registration or conditions. The request will be viewed by director incharge and in case of eligibility, it would be shared in two weeks.
Comments
I want randomized clinical trial registration.
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