The main aim of this study is to determine the effects of mechanical cervical traction with and without sustained natural apophyseal glides (SNAGs) on pain, functional disability and quality of life among patients with mechanical neck pain.
Design
It will be single blinded study, in which the accessor will be unaware of the treatment group.
Settings and conduct
The data will be collected from the University of Lahore Teaching Hospital. The study population will be consisted of patients with mechanical neck pain.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
•Both male and female academic staff of University of Lahore.
•Patients with NPRS score between 3 and 6 for more than three months.
•Patients with screen time greater than 6 hours per day.
Exclusion criteria:
•Degenerative diseases ( inflammatory arthritis, osteoporosis, osteoarthritis)
•Recent weight loss and history of tumor around neck.
•Patient taking anticoagulants.
•History of neck trauma due to RTA, fall or other accidents.
•Recent fracture or dislocation.
•Previous surgery of cervical and upper thoracic spine.
•Pregnant females.
Intervention groups
Intervention Group A: Mechanical cervical traction with SNAGS and routine physical therapy to check how it influence the pain, functional disability and quality of life.
Group B: mechanical cervical traction and routine physical therapy will be provided to the patients
Main outcome variables
Numeric Pain Rating Scale for Pain
Neck Disability Index for Functional Disability
Short Form -36 for Quality of Life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240808062691N1
Registration date:2024-08-21, 1403/05/31
Registration timing:registered_while_recruiting
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
Ayesha Naeem
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 35450222
Email address
ayeshawahab60@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-21, 1403/01/02
Expected recruitment end date
2024-09-03, 1403/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
MECHNICAL CERVICAL TRACTION WITH AND WITHOUT SNAGS ON PAIN, FUNCTIONAL DISABILITY AND QUALITY OF LIFE AMONG PATIENTS WITH MECHANICAL NECK PAIN
Public title
Mechanical cervical traction with and without SNAGS among patients with mechanical neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient of both genders with age from 25-40 years.
Patients with NPRS score between 3 and 6 for more than three months.
Patients with screen time greater than 6 hours per day.
Exclusion criteria:
Patients with degenerative diseases ( inflammatory arthritis, osteoporosis, osteoarthritis)
Recent weight loss and history of tumor around neck.
Patient taking anticoagulants.
History of neck trauma due to RTA, fall or other accidents.
Recent fracture or dislocation.
Previous surgery of cervical and upper thoracic spine.
Pregnant females.
Age
From 25 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The lottery method of randomization will be used to divide the participants into experimental group and control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single blinded study in which outcome assessor will be unaware of the treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee Faculty of Allied Health Sciences The University of Lahore
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2024-03-08, 1402/12/18
Ethics committee reference number
REC-UOL-/131/8/24
Health conditions studied
1
Description of health condition studied
Mechanical neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia ( mechanical neck pain)
Primary outcomes
1
Description
pain
Timepoint
Before intervention and at the 2nd and 4th weeks after intervention
Method of measurement
Numeric pain rating scale (NPRS)
2
Description
Functional disability
Timepoint
Before intervention and at the 2nd and 4th weeks after intervention
Method of measurement
Neck Disability Index (NDI)
3
Description
Quality Of Life
Timepoint
Before intervention and at the 2nd and 4th weeks after intervention
Method of measurement
36-Item Short Form Survey (SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: this group will receive mechanical cervical traction with SNAGs and routine physical therapy
Category
Treatment - Devices
2
Description
Control group: this group will receive mechanical cervical traction with routine physical therapy
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Lahore Teaching Hospital
Full name of responsible person
Dr. Asim Arif
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 335 1450137
Email
asim.arif@uipt.uol.edu.pk
Web page address
https://uol.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Ayesha Naeem
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 318 4002992
Email
ayeshawahab60@gmail.com
Grant name
none
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
none
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
Ayesha Naeem
Position
Student
Latest degree
Master
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 42 35450222
Email
ayeshawahab60@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Ayesha Naeem
Position
Student
Latest degree
Master
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 42 35450222
Email
ayeshawahab60@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Ayesha Naeem
Position
student
Latest degree
Master
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 42 35450222
Email
ayeshawahab60@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic data and data related to final outcome will be shared by maintaining the confidentially.
When the data will become available and for how long
Data will be available after the publication of findings till six moths
To whom data/document is available
Ayesha Naeem
Under which criteria data/document could be used
for research purpose only
From where data/document is obtainable
To the corresponding author of the study, Ayesha Naeem and can contact on +923184002992, ayeshawahab60@gmail.com
What processes are involved for a request to access data/document
Open access and there is the traditional public data release where anyone can get access to the data.