To find out the effects of thoracic mobilization with and without sling based thoracic active exercises on pain, function and quality of life in patients with non-specific neck pain.
Design
It is a Randomized controlled trial. Sample size is estimated to be 44 i.e: 22 in each group. After adding drop out rate the sample size is 52 i.e: 26 in each group. There are two groups namely group A and group B. Group A will receive sling-based thoracic active exercises with thoracic mobilization and cervical manual therapy for 4 weeks while geoup B will receive thoracic mobilization and cervical manual therapy for 4 weeks. Data will be collected at 3 intervals i.e: 0 week (baseline), 2nd week and 4th week (after completion of treatment) from both groups. Participants will be allocated to the groups randomly by using lottery method to minimize bias. It is a single blinded study, accessor is blinded. Study is conducted at Physiotherapy department of University of Lahore Teaching Hospital Lahore.
Settings and conduct
University of Lahore Teaching Hospital Physiotherapy department. It is a single blinded study, assessor will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
20-45 years old, Both males and females are included, diagnosed patients of non-specific neck pain, NDI score equal to or more than 24
Exclusion Criteria:
The presence of neurological signs and symptoms, previous surgical history related to spine or neck, Currently undergoing any injection treatment to reduce pain, Neurological issues, Pregnancy, Cardiac disease , Active infection
Intervention groups
Group A: sling-based thoracic active exercises with thoracic mobilization and cervical manual therapy
Group B: thoracic mobilization and cervical manual therapy
Main outcome variables
Pain
Function
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240518061828N1
Registration date:2024-08-27, 1403/06/06
Registration timing:retrospective
Last update:2024-08-27, 1403/06/06
Update count:0
Registration date
2024-08-27, 1403/06/06
Registrant information
Name
Samer Zehra
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 111 865 865
Email address
Samkazmi1111@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-15, 1402/11/26
Expected recruitment end date
2024-08-01, 1403/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Thoracic mobilization versus sling-based thoracic active exercises on pain, function and quality of life in patients with non-specific neck pain
Public title
Thoracic mobilization versus sling-based thoracic active exercises on pain, function and quality of life in patients with non-specific neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-45 years old
Both male and female
Diagnosed with non-specific neck pain
NDI score is equal to or more than 24
Exclusion criteria:
The presence of neurological signs and symptoms
Previous surgical history related to spine or neck
Currently undergoing any injection treatment to reduce pain
Neurological issues
Pregnancy
Cardiac disease
Active infection
Age
From 20 years old to 45 years old
Gender
Both
Phase
0
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
After screening, all the participants will be randomly allocated into 2 groups through lottery method: Group A (Experimental group: Sling based thoracic active exercise + thoracic mobilization + cervical manual therapy) and Group B (Control group: Thoracic mobilization + cervical manual therapy)
Blinding (investigator's opinion)
Single blinded
Blinding description
In a single-blinded study where the assessor is blind, the person evaluating the outcomes or measurements of the study participants is unaware of which participants belong to the control group and which belong to the experimental group. This helps to prevent bias in the assessment of the outcomes
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical committee of the University of Lahore
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2024-05-06, 1403/02/17
Ethics committee reference number
REC-UOL-/130/80/24
Health conditions studied
1
Description of health condition studied
Non-specific neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 2 week and 4th Week (after intervention)
Method of measurement
Numeric pain rating scale
2
Description
Function
Timepoint
Before intervention, 2 week and 4th Week (after intervention)
Method of measurement
Neck disability index
3
Description
Quality of life
Timepoint
Before intervention, 2 week and 4th Week (after intervention)
Method of measurement
SF-36 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Thoracic mobilization with sling-based thoracic active exercises group and cervical manual therapy
Category
Treatment - Other
2
Description
Control group:Thoracic mobilization and cervical manual therapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Lahore Teaching Hospital
Full name of responsible person
Dr. Iqra Waseem
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
70136320@student.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Samer Zehra
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
70136320@student.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
University of Lahore
Full name of responsible person
Samer Zehra
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 42 111 865 865
Email
70136320@student.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Samer Zehra
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 42 111 865 865
Email
70136320@student.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Samer Zehra
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 42 111 865 865
Email
70136320@student.uol.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD