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Comparison of effects of straight leg raising technique and slump stretching technique in patients with lumbosacral radiculopathy

Protocol summary

Study aim
To compare the effects of straight leg raising technique and slump stretching technique on pain, ROM and disability in patients with lumbosacral radiculopathy.
Design
Single-blinded,clinical trial with a parallel group design of 28 patients. Lottery method will be used for randomisation.
Settings and conduct
Study design will be Randomized Clinical Trial. It will be done at Shaikh Zayed Hospital, Lahore. It's a single blinded trial in which the participants are deliberately kept ignorant of either the group to which they have been assigned.
Participants/Inclusion and exclusion criteria
Inclusion criteria  Between the ages of 30 to 50.  Having symptoms travelling away from the hips.  Provocation of symptoms with a straight leg raise test between 45 ° to 70 °.  Experiencing mild to moderate pain (2 to 6 in the NPRS) and baseline Modified Oswestry Disability Index (MODI) of score higher than 10%. Exclusion criteria  Present with '' red flags '' of critical spinal condition (e.g. infection, tissue, osteoporosis, fractured spine, etc.).  Pregnant women.  History of spinal surgery.  Inability to hold the advisory position of slump stretching, reproduction of symptoms on neck flexion during slump test examination, showing a straight leg test (SLR) less than 45°.  Lumbar spine pathologies such as spondylolisthesis, spondylolysis, spinal canal stenosis, spinal deformity, diabetes, infective or metabolic polyneuropathy, ankylosing spondylitis, systemic cause of back pain.
Intervention groups
Group A- Slump Stretching Technique Group B- Straight Leg Raising Technique
Main outcome variables
Pain intensity will be measured through Numeric Pain Rating Scale. Straight Leg Raise range of motion will be measured through Goniometer. Disability will be measured through Modified Oswestry Disability Index.

General information

Reason for update
Acronym
CESLRSSTLR
IRCT registration information
IRCT registration number: IRCT20190715044216N2
Registration date: 2021-12-23, 1400/10/02
Registration timing: prospective

Last update: 2021-12-23, 1400/10/02
Update count: 0
Registration date
2021-12-23, 1400/10/02
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
2022-06-01, 1401/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of straight leg raising technique and slump stretching technique in patients with lumbosacral radiculopathy
Public title
Comparison of effects of straight leg raising technique and slump stretching technique in patients with lumbosacral radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Between the ages of 30 to 50. Having symptoms travelling away from the hips. Provocation of symptoms with a straight leg raise test between 45 ° to 70 ° Experiencing mild to moderate pain (2 to 6 in the NPRS) Baseline Modified Oswestry Disability Index (MODI) of score higher than 10%
Exclusion criteria:
Present with '' red flags '' of critical spinal condition (e.g. infection, tissue, osteoporosis, fractured spine, etc.). Pregnant women History of spinal surgery. Inability to hold the advisory position of slump stretching, reproduction of symptoms on neck flexion during slump test examination. Showing a straight leg test (SLR) less than 45°. Lumbar spine pathologies such as spondylolisthesis, spondylolysis, spinal canal stenosis, spinal deformity, diabetes, infective or metabolic polyneuropathy, ankylosing spondylitis, systemic cause of back pain.
Age
From 30 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
Sample size
Target sample size: 28
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 be carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant is blind in this study. The participants will deliberately be kept ignorant of either the group to which they have been assigned or key information about the materials they are being assessed of, but the experimenter will be in possession of this knowledge.
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, Lahore and from the Clinical
Street address
Riffle Range Road
City
Lahore
Postal code
54000
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
S20C14G30013

Health conditions studied

1

Description of health condition studied
Lumbosacral Radiculopathy
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region

Primary outcomes

1

Description
Pain
Timepoint
Four sessions of treatment per week with total sixteen sessions will be given in four weeks.
Method of measurement
Numeric Pain Rating Scale

2

Description
Disability
Timepoint
Four sessions of treatment per week with total sixteen sessions will be given in four weeks.
Method of measurement
Modified Oswestry Disability Index

3

Description
Range of Motion
Timepoint
Four sessions of treatment per week with total sixteen sessions will be given in four weeks.
Method of measurement
Goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Slump Stretching Technique. The subjects will receive slump stretching technique and common treatment. Common treatment includes TENS and lumbar stabilization exercise. TENS will be given for 10 minutes with 4 sessions of Lumbar stabilization exercise for 4 days/week for 4 weeks. Total treatment protocol will be of 16 sessions, 4 days /week for 4 weeks. Total duration of each session will be 25-30 minutes.
Category
Rehabilitation

2

Description
Intervention group: Straight Leg Raising Technique. The subjects will receive straight leg raise stretching technique and common treatment. Common treatment includes TENS and lumbar stabilization exercise. TENS will be given for 10 minutes with 4 sessions of Lumbar stabilization exercise for 4 days/week for 4 weeks. Total treatment protocol will be of 16 sessions, 4 days /week for 4 weeks. Total duration of each session will be 25-30 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaikh Zayed Hospital Lahore
Full name of responsible person
Dr.Imtiaz Ahmad
Street address
Riffle Range Road
City
Lahore
Postal code
54000
Phone
+92 42 36612321
Email
sidfirdous.99@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Sidra Firdous Iqbal
Street address
Riffle Range Road
City
Lahore
Postal code
54000
Phone
+92 42 36612321
Email
sidfirdous.99@gmail.com
Grant name
Not available
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Nil
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
Sidra Firdous Iqbal
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Riffle Range Road
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 36612321
Email
sidfirdous.99@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Sidra Firdous Iqbal
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Riffle Range Road
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 36612321
Email
sidfirdous.99@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Sidra Firdous Iqbal
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Riffle Range Road
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 36612321
Email
sidfirdous.99@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
Comparison of effects of straight leg raising technique and slump stretching technique in patients with lumbosacral 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
email addresses- sidfirdous.99@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.
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