The objective of the study is to compare the effects of Mulligan Traction Leg Raise versus Slump Stretching on Pain, Passive Leg Raise, and Functional Disability in Lumbar Radiculopathy
Design
A concealed, randomized, single blinded, clinical trial with a parallel group design of 44 patients. Lottery method will be used for Randomization.
Settings and conduct
It will be Randomized clinical trial
Study will be conducted in Family Clinic Baghbanpura, Lahore
It is a Single blinded trial in which the participants are deliberately kept ignorant of either the group to which they have been assigned or key information about the materials they are assessing
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Pre diagnosed with lumbar radiculopathy
• Age group of 30-60 years
• SLR test positive
• All subjects with unilateral or bilateral radiation of pain in sciatic nerve distribution
• Female patients
• Participants willing to participate in the study
2 Exclusion criteria:
• History of spinal surgery in previous 6 months
• Knee and ankle pathology causing limitation of movement
• Clinical conditions such as over sensitive skin, patient with cardiac pacemaker, pregnancy etc,
• Serious spinal condition e.g infection, tumors, osteoporosis, spinal fracture
• Inability to hold slump stretching position, reproduction of symptoms on neck flexion part of slump test
• Patients with cervicogenic headache, VBI, spinal deformities and ankylosing spondylitis
Intervention groups
Group A : Mulligan Traction Leg Raise
Group B : Slump Stretching
Main outcome variables
Pain will be measured through Numeric Pain Rating Scale (NPRS)
Straight leg raise range of motion will be measured through Goniometer
Disability will be measured through Oswestry disability index scale
General information
Reason for update
Acronym
EMTLRSSSPPLRFDLR
IRCT registration information
IRCT registration number:IRCT20190715044216N3
Registration date:2021-12-27, 1400/10/06
Registration timing:prospective
Last update:2021-12-27, 1400/10/06
Update count:0
Registration date
2021-12-27, 1400/10/06
Registrant information
Name
Naveed Anwar
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
naveedanwar982@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Mulligan Traction Leg Raise versus Slump Stretching on Pain, Passive Leg Raise, and Functional Disability in Lumbar Radiculopathy
Public title
Effects of Mulligan Traction Leg Raise versus Slump Stretching on Pain, Passive Leg Raise, and Functional Disability in Lumbar Radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pre diagnosed with lumbar radiculopathy
Age group of 30-60 years
SLR test positive
All subjects with unilateral or bilateral radiation of pain in sciatic nerve distribution
Male and Female patients
Participants willing to participate in the study
Exclusion criteria:
History of spinal surgery in previous 6 months
Knee and ankle pathology causing limitation of movement
Clinical conditions such as over sensitive skin, patient with cardiac pacemaker, pregnancy etc.
Serious spinal condition e.g. infection, tumors, osteoporosis, spinal fracture
Inability to hold slump stretching position, reproduction of symptoms on neck flexion part of slump test
Patients with cervicogenic headache, VBI, spinal deformities and ankylosing spondylitis
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by lottery method through convenient sampling.
Unit of randomization is Individual.
Tool used in randomization will be lottery method.
Through lottery method each member of the population will be assigned a number, after which numbers will be selected at random.
Allocation concealment will carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
1. It will be a single blinded study
2. Participants of both groups will be kept unfamiliar to the treatment protocol by lottery method.
3. Participants of both groups will be called for treatment on alternate days in a week.
4. Group A will receive Mulligan traction leg raise and lumbar stabilization exercises for 3 days a week and Group B will receive Slump stretching and lumbar stabilization exercises for next 3 days a week.
5. The health care provider (physical therapist) will be aware to the whole treatment procedure that will be provided to the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Review Committee of Riphah College of Rehabilitation Sciences
Street address
Jubilee town , A Block, House no 514
City
Lahore
Postal code
54000
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
REC/RCR & AHS/21/0105
Health conditions studied
1
Description of health condition studied
lumbar radiculopathy
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region
Primary outcomes
1
Description
Pain
Timepoint
Treatment session includes 3 times per week for 4 weeks for 20 minutes and outcomes will be measured before applying intervention in 1st week and after completion of treatment at 4th week.
Method of measurement
NPRS
2
Description
Straight leg raise range of motion
Timepoint
Treatment session includes 3 times per week for 4 weeks for 20 minutes and outcomes will be measured before applying intervention in 1st week and after completion of treatment at 4th week.
Method of measurement
Goniometer
3
Description
Disability
Timepoint
Treatment session includes 3 times per week for 4 weeks for 20 minutes and outcomes will be measured before applying intervention in 1st week and after completion of treatment at 4th week.
Method of measurement
Oswestry disability index scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Mulligan Traction Leg Raise : The subjects will receive Mulligan traction leg raise and and common treatment. Mulligan traction leg raise at available end range will be hold for 10 seconds with max. 3 repetitions. The common treatment include lumbar stabilization exercises. Lumbar stabilization exercises includes static glutei, static back and static hamstring hold for 10 seconds with maximum 10 repetitions. Treatment session was given 3 times per week for 4 weeks. Total duration of each session will be of 20 minutes.
Category
Rehabilitation
2
Description
Intervention group B: Slump Stretching : The subjects will receive Slump stretching and common treatment. Slump Stretching position will be maintained for ten seconds with each session following 3 repetition stretches according to patient’s response. Lumbar stabilization exercises. The common treatment include lumbar stabilization exercises. Lumbar stabilization exercises includes static glutei, static back and static hamstring hold for 10 seconds with maximum 10 repetitions. Treatment session includes 3 times per week for 4 weeks. Total duration of each session will be of 20 minutes. Evaluation will be done before treatment and at the end of 4th week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Family clinic
Full name of responsible person
Dr. Anjum Rasheed
Street address
Ghas mandi stop Gt.road
City
Lahore
Postal code
54000
Phone
+92 42 32525250
Email
aqsairshad958@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Aqsa Irshad
Street address
Jubilee town A block house no 514
City
Lahore
Postal code
54000
Phone
+92 42 32525250
Email
aqsairsahad958@gmail.com
Grant name
Riphah International University
Grant code / Reference number
not applicable
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Nill
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Aqsa Irshad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jubilee Town A Block House no 514
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32525250
Email
aqsairshad958@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Aqsa Irshad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jubilee town A Block house no 514
City
Lahore
Province
Punjab
Postal code
54000
Phone
042325252520
Email
aqsairshad958@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Aqsa Irshad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jubilee town A Block house no 514
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32525250
Email
aqsairshad958@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
Effects of Mulligan Traction Leg Raise versus Slump Stretching on Pain, Passive Leg Raise, and Functional Disability in Lumbar Radiculopathy
When the data will become available and for how long
30th June 2022
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Author will review the requests
From where data/document is obtainable
gmail address: aqsairshad958@gmail.com
What processes are involved for a request to access data/document
Requests will be entertained through email after which people working in academic institutions will be granted request