The previous literature shows lack of studies specifically comparing the effects of routine physiotherapy with and without FDM on pain, functional disability, and ROM in patients with CLBP. Understanding the effects of routine physiotherapy with and without FDM on pain, functional disability, and ROM in patients with CLBP can provide valuable insights into the effectiveness of these interventions and guide evidence-based clinical decision-making. The findings of this study may have implications for the development of more effective treatment protocols for chronic low back pain.
Design
Parallel study with conveniet sampling technique . It is a Randomized Control Trial with single blinding of group division. Data will be collected for 6-9 months after approval
Settings and conduct
Data will be collected from DHQ hospital Muzaffargarh
Participants/Inclusion and exclusion criteria
Inclusion criteria: low back pain of more than 3 months; age 30-65 years old; both male and female.
Exclusion criteria: low back pain associated with any structural deformity e.g scoliosis; osteoporosis; spinal fracture; LBP with Radicular symptoms; cauda equina syndrome.
Intervention groups
Fascial distortion model will be implied as Intervention group. There will be a three-week treatment plan with total 6 sessions each group that can be divided into baseline, first week second week and third week, comparing the two interventions.
Main outcome variables
Pain
General information
Reason for update
Acronym
FDM
IRCT registration information
IRCT registration number:IRCT20240513061772N1
Registration date:2024-07-22, 1403/05/01
Registration timing:registered_while_recruiting
Last update:2024-07-22, 1403/05/01
Update count:0
Registration date
2024-07-22, 1403/05/01
Registrant information
Name
Sana Saghir
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 314 6319023
Email address
sanasagheer14330@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-09, 1403/02/20
Expected recruitment end date
2024-11-09, 1403/08/19
Actual recruitment start date
2024-05-09, 1403/02/20
Actual recruitment end date
2024-09-15, 1403/06/25
Trial completion date
2024-11-10, 1403/08/20
Scientific title
Fascial distortion model on pain , functional disability and Range of motion in patients with chronic low back pain
Public title
Fascial distortion model in chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Low back pain of more than 3 months
Age 30-65 years
Both genders
Exclusion criteria:
Low back pain associated with any structural deformity e.g scoliosis
Patient with osteoporosis or spinal fractures are not included
Low back pain with radicular symptom not included
Cauda equina syndrome not included
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
94
Actual sample size reached:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation into two groups through computer generated numbers. Allocation was concealed
Blinding (investigator's opinion)
Single blinded
Blinding description
Study will be single blinded. The participants will be unaware of which group they have been allocated
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
2024-05-09, 1403/02/20
Ethics committee reference number
REC-UOL-135/8/24
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
S39.01
ICD-10 code description
Strain of muscle, fascia and tendon of abdomen, lower back and pelvis
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and immediately after treatment and 3 weeks after treatment
Method of measurement
Visual analog pain scale
Secondary outcomes
1
Description
Functional disability
Timepoint
Before and after treatment and At the end of 3rd week of intervention
Method of measurement
Roland-Morris disabilitt questionnaire
2
Description
Range of Motion
Timepoint
Before and after treatment and at the end of 3rd week of intervention
Method of measurement
Inclinometer
Intervention groups
1
Description
Intervention group: Fascial distortion model group
Category
Rehabilitation
2
Description
Control group: Hot pack , TENS , stretching and mobilization exercises
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
DHQ hospital Muzaffargarh
Full name of responsible person
Muhammad Saqib Fareed
Street address
0.5 Km from district courts DHQ hospital Alipur road , Distric Muzaffargarh
City
Muzaffargarh
Postal code
34200
Phone
+92 306 0066879
Email
dhqmgarh@gmail.com
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
Sana Sagheer
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House#2 near oasis hotel Jhang road Muzaffargarh
City
Muzaffargarh
Province
Punjab
Postal code
34200
Phone
+92 306 0066879
Email
sanasagheer14330@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, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 318 3466879
Email
sanasagheer14330@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Sana Sagheer
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House#2 near oasis hotel Jhang road Muzaffargarh
City
Muzaffargarh
Province
Punjab
Postal code
34200
Phone
+92 306 0066879
Email
sanasagheer14330@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
Demographic data and data related to final outcome will be shared by maintaining the comfidentiality
When the data will become available and for how long
Data will be available from feb 2025 to May 2025 after the six months of publication the data sharing plan for a clinical trial (i.e, what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's international clinical trials registry platform, this occurs before the first participant is enrolled
To whom data/document is available
Dr Sana tauqeer ( corresponding author ) senior lecturer at The university of lahore- lahore
Under which criteria data/document could be used
For research purpose
From where data/document is obtainable
To the corresponding author of the study, Dr sana tauqeer and can contact on +92 324 4294807 . Can visit these research engines, you can easily find my study here 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 with no registration or conditions. The request will be reviewed by director incharge and incase of eligibility , it would be shared in 2 weeks