Protocol summary

Study aim
To check the effect of Myofascial release and muscle energy technique on quadratus lumborum in patients with non-specific low back pain patients
Design
A randomized clinical trial was conducted with three parallel groups, a single blinded study of third phase in 20 patients in each group that are 60 in total .
Settings and conduct
Allied hospital faisalabad and Madinah teaching hospital .
Participants/Inclusion and exclusion criteria
Informed consent of the patient Diagnosed patient with non specific low back pain Age 18 to 40 years Gender both male and female Patient with pain at the attachment of quadratus lumborum Patients with restricted lateral flexion less than 25 degrees Pain on NPRS in range between 3-7 Patients with history of any spinal surgery in past six months Pathology of spine like tumor,tuberculosis,osteoporosis etc Patients with altered sensation (motor or sensory) Patient with spinal cord injury in past six months Any pathological condition related to hip joint e.g arthritis ,total knee replacement,total hip replacement or pregnancy etc.
Intervention groups
GRP A:First, a hot pack is administered as a baseline treatment. 3reps of the treatment will take a total of 15 min. MET of QL given for 10-30 sec GRP B: The caudal hand was put on the participant's thigh, while the cranial arm's elbow was positioned above QL. Elbow was positioned obliquely close to the center of the column, applying minimal pressure. The individual's leg was gently pulled sideways by another hand. There are seven minutes . GRP C:total treatement time is 22 mins .Both techniques METand MFR is given in this group.
Main outcome variables
NPRS , ODI and Inclinometer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240330061389N1
Registration date: 2024-08-05, 1403/05/15
Registration timing: registered_while_recruiting

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Amna Anwar
Name of organization / entity
The University of Faislabad
Country
Pakistan
Phone
+92 41 2647086
Email address
amnaanwar262@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-15, 1403/01/27
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of myofascial release and muscle energy technique on quadratus lumborum in patients with non specific low back pain
Public title
Effect of MFR and met on quadratus lumborum in non specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of the patient Diagnosed patient with non specific low back pain Age 18 to 40 years Gender both male and female Patient with pain at the attachment of quadratus lumborum Patients with restricted lateral flexion less than 25 degrees Pain on NPRS in range between 3-7
Exclusion criteria:
Patients with history of any spinal surgery in past six months Pathology of spine like tumor, tuberculosis, osteoporosis etc Patients with altered sensation (motor or sensory) Patient with spinal cord injury in past six months Any pathological condition related to hip joint e.g arthritis ,total knee replacement ,total hip replacement or pregnancy etc.
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by lottery method and study was single blinded they did not know in which study group they are allocated.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blinded in the study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and ethic / technical committee for The University of Faisalabad
Street address
University avenue faisal town canal road
City
Faisalabad
Postal code
38000
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
TUF/DR/SA/MSPT/2024/420

Health conditions studied

1

Description of health condition studied
Non specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Non specific low back pain
Timepoint
Before intervension or after six weeks of intervension
Method of measurement
Inclinometer

Secondary outcomes

1

Description
Functional disability
Timepoint
Before intervention and at the end of six weeks of intervension
Method of measurement
Oswestry Disability Index

Intervention groups

1

Description
Intervention group1 : muscle energy technique Intervention group 2 : myofascial release technique Intervention group 3 : Both these techniques were used
Category
Treatment - Devices

2

Description
Intervention group1 : muscle energy technique Intervention group 2 : myofascial release technique Intervention group 3 : Both these techniques were used
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Madinah Teaching Hospital
Full name of responsible person
Amna Anwar
Street address
Sargodha road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 335 6515086
Email
amnaanwar262@gmail.com

2

Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Amna Anwar
Street address
DR. Tusi road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 335 6515086
Email
amnaanwar262@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Amna Anwar
Street address
University avenue faisal town canal road
City
Faisalabad
Postal code
38000
Phone
+92 335 6515086
Email
amnaanwar262@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University Of Faisalabad
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 Faisalabad
Full name of responsible person
Amna Anwar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Green veiw colony ,hamza block house no 303/1 faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2647086
Email
amnaanwar262@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Amna Anwar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Green view colony, hamza block house no 303/1 faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2647086
Email
amnaanwar262@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Amna Anwar
Position
Punjab
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Green view colony , hamza block house no 303/1 faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2647086
Email
amnaanwar262@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
No - There is not 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
Effect of myofascial release and muscle energy technique on quadratus lumborum in patients with non specific low back pain
When the data will become available and for how long
Starting six months after publication and it will remain available for everyone
To whom data/document is available
This will be available for everyone
Under which criteria data/document could be used
amnaanwar262@gmail.com00923356515086
From where data/document is obtainable
amnaanwar262@gmail.com00923356515086
What processes are involved for a request to access data/document
Any applicant just need to contact for data, contact through email at amnaanwar262@gmail.com
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