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Comparison of Mulligan Bent Leg Raise versus Mulligan Traction Straight Leg ‎Raise on pain intensity and hamstring flexibility in patients with non-specific ‎chronic low back pain

Protocol summary

Study aim
To compare Mulligan Bent Leg Raise versus Mulligan Traction Straight Leg Raise on pain ‎intensity and hamstring flexibility in patients with non-specific chronic low back pain‎
Design
Two-arm, parallel-group, randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
The study was conducted at Health Care Physiotherapy, Sports, Spine& Rehabilitation ‎Center, Faisalabad, 116 Patients were randomly allocated ‎into groups, Group A received Mulligan Traction Straight Leg Raise (TSLR) while ‎Group B patients received Mulligan Bent Leg Raised Technique (BLR).
Participants/Inclusion and exclusion criteria
Inclusion criteria:‎ Age between 30-50 years‎, Both gender (male & f0emale, Visual Analog Scale Pain Score 0-7 (Mild Pain 0-4, Moderate Pain 5-7)‎, Non-specific chronic low back pain involving segmental hypomobility and gross ‎limitation of lumber mobility and restriction of SLR, due to discomfort & pain, 15˚ more as compared to the non-involved side.‎ Exclusion criteria:‎Visual Analog Scale Pain Score 8-10 (Unbearable Pain)‎, Patient already taking treatment for last 6 months, any neurological disease, any physical disability, Pregnancy, history of any surgical procedure involving back or lower extremity.
Intervention groups
Intervention group A: Traction Straight Leg Raise (TSLR)‎ The Mulligan traction straight leg raise technique was used therapeutically to decrease pain and ‎range of straight leg raise when it was limited due to tightness in hamstrings or dysfunction in ‎the lower back. Group B: Bent Leg Raised Technique (BLR)‎ The Mulligan bent leg raise method was used for improving the range of straight leg raise in subjects ‎with nonspecific chronic low backache in order to improve hamstring flexibility in individuals ‎with hamstrings tightness. ‎
Main outcome variables
Pain; range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200221046567N4
Registration date: 2021-05-17, 1400/02/27
Registration timing: retrospective

Last update: 2021-05-17, 1400/02/27
Update count: 0
Registration date
2021-05-17, 1400/02/27
Registrant information
Name
Muhammad Kashif
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 41 8777210
Email address
kashif.shaffi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-10-01, 1398/07/09
Actual recruitment start date
2019-03-01, 1397/12/10
Actual recruitment end date
2019-10-01, 1398/07/09
Trial completion date
2019-10-01, 1398/07/09
Scientific title
Comparison of Mulligan Bent Leg Raise versus Mulligan Traction Straight Leg ‎Raise on pain intensity and hamstring flexibility in patients with non-specific ‎chronic low back pain
Public title
Comparison of Mulligan Bent Leg Raise versus Mulligan Traction Straight Leg ‎Raise on pain intensity and hamstring flexibility in patients with non-specific ‎chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-50 Years‎ Both Gender Male & Female Visual Analog Scale Pain Score 0-7 (Mild Pain 0-4, Moderate Pain 5-7)‎ Non-specific chronic low backache involving segmental hypomobility and gross ‎limitation of lumber mobility Restriction of SLR, due to discomfort & pain, 15˚ more as compared to the non-involved side.
Exclusion criteria:
Visual Analog Scale Pain Score 8-10 (Unbearable Pain)‎ The patient already taking treatment for the last 6 months.‎ any neurological disease Pregnancy History of any surgical procedure involving back or lower extremity
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 116
Actual sample size reached: 116
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization was done bases on the following steps Step-1: First the population of the study was exactly defined though inclusion criteria, complete ‎list of people included in the population were made. The population of the study was 1,000 each ‎person was labeled from one to one thousand.‎ Step-2: The sample size of the study was 116 people calculated based on previous study. Sample of 116 people were selected using ‎excel function RAND. The formula for this was “=RAND ()*1000” 116 random numbers were ‎generated.‎ Step-3: In this study researcher framed two groups, one was experimental group and other was ‎control group, in each group 58 people were decided to include. To select 58 people for each ‎group excel function RAND was used. First 116 people were labeled from one to one hundred and sixteen.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor was kept blind about either the patient belonged to the treatment group or the control ‎group. A second physical therapist assessed pain and hamstring flexibility.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board of University Institute of Physical Therapy, The University of Lahore
Street address
Defense Road
City
Lahore
Postal code
4200
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IRB-UOL-FAHS/437/2019

Health conditions studied

1

Description of health condition studied
Low back pain
ICD-10 code
M54.56
ICD-10 code description
Low back pain, lumbar region

Primary outcomes

1

Description
Pain
Timepoint
before intervention and 2, 4 , 6 weeks after intervention
Method of measurement
Visual Analogue Scale

2

Description
Range of Motion
Timepoint
before intervention and 2, 4 , 6 weeks after intervention
Method of measurement
Universal Goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: The Mulligan traction straight leg raise technique is used therapeutically to decrease pain and ‎range of straight leg raise when it is limited due to tightness in hamstrings or dysfunction in ‎lower back. ‎Moist heating pads were applied on lower back & hamstrings muscles for 10 minutes before ‎each treatment session. Bridging and flexion or extension biased exercises were also ‎performed as baseline treatment.‎All patients received 06 treatment sessions in total over a three-week period‎.
Category
Treatment - Other

2

Description
Intervention group 2: The Mulligan traction straight leg raise technique is used therapeutically to decrease pain and ‎range of straight leg raise when it is limited due to tightness in hamstrings or dysfunction in ‎lower back. Moist heating pads were applied on lower back & hamstrings muscles for 10 minutes before ‎each treatment session. Bridging and flexion or extension biased exercises were also ‎performed as baseline treatment.‎ All patients received 06 treatment sessions in total over a three-week period‎.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Care Physiotherapy, Sports, Spine & Rehabilitation Center, Faisalabad, Punjab, ‎Pakistan.‎
Full name of responsible person
Hafiz Muhammad Junaid Hassan
Street address
Muslim Town 2
City
Faisalabad
Postal code
3800
Phone
+92 41 5068065
Email
junaidhassan1192@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Prof. Dr Ashfaq Ahmad
Street address
Defense Road
City
Lahore
Postal code
4200
Phone
+92 42 35322501
Email
ashfaq.ahmad@uipt.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
HAFIZ MUHAMMAD JUNAID HASSAN
Position
Postgraduate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Defense Road
City
Lahore
Province
Punjab
Postal code
4200
Phone
+92 42 35322501
Email
junaidhassan1192@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
HAFIZ MUHAMMAD JUNAID HASSAN ‎
Position
Postgraduate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Defense Road
City
Lahore
Province
Punjab
Postal code
4200
Phone
+92 42 35322501
Email
junaidhassan1192@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
HAFIZ MUHAMMAD JUNAID HASSAN ‎
Position
Postgraduate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Defense Road
City
Lahore
Province
Punjab
Postal code
4200
Phone
+92 42 35322501
Email
junaidhassan1192@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
Undecided - It is not yet known if there will be 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
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
IPD collected for the primary outcome measure only
When the data will become available and for how long
After the publication of the study.
To whom data/document is available
academic institutions and researchers
Under which criteria data/document could be used
academic institutions and researchers
From where data/document is obtainable
via email or telephonic contact with investigators
What processes are involved for a request to access data/document
on email request, data will be provided within 15 days.
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