- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05955781
Effects Of Spinal Mobilization With Leg Movement on Pain And Disability in Patients With Lumbar Radiculopathy
July 19, 2023 updated by: Foundation University Islamabad
This study will be a Randomized Control Trial in which Both Genders with Age between 20 to 50 Years who had diagnosed with lumbar radiculopathy will be recriuted in to two groups.group
A will be recieving spinal mobilzation with leg movement along with TENS & hot pack.whie group B will be given only spinal mobilization with TENS & hot pack.before and after the introduction of interventions pain,disabaility,speed of gait,cadence and SLR will be checked before and after the treatment
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Lumbar Radiculopathy is a medical condition that occurs when one or more nerve roots in the spinal cord are compressed or damaged, leading to pain, weakness, numbness or tingling sensations in the affected area of the body.
This condition can be caused by herniated discs, spinal stenosis, Degenerative disc disease, tumors and infections.This study will be a Randomized Control Trial.The study will be conducted in district Swabi.
We will recruit the data from NCS University Rehabilitation Centre Swabi.oswestry
disbaility index will be given at the start of study and NPRS to check their pain and disbaility levels.SMWLM will be given to experimental group.Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.The patient receives a set of three repetitions, then three sets of six repetitions, with a 30-second break in between each set of treatments.
In this session, a progression was also provided as free SLR overpressure.
A total of 6 sessions will be given thrice a week on alternate days for 2 consecutive weeks.
The treatment will be given with 5 repetitions of SMWLM and 10 repetitions of spinal mobilization with three sets of transverse glide.
Total time duration of the treatment will be around 25-35 minutes§ Pre assessment will be conducted at baseline followed by intervention for 3 days per week for 6 consecutive weeks.Final assessment will be conducted at the end of 6 weeks of intervention
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
KPK
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Swabi, KPK, Pakistan, 23430
- NCS University Rehabilitaion Centre Swabi
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients diagnosed with lumbar Radiculopathy with unilateral radiating leg pain.
- Both Genders with Age between 20 to 50 Years.
- Patient willing to participate and complete their follow-ups.
- Pain from (0-35 degrees) in Straight Leg Raise(Dural Pain).
- Positive neurodynamic test i.e. SLR test(35-70 degrees),which indicate sciatica)
- Pain more 3-5 or More on NPRS.
Exclusion Criteria:
- Spinal stenosis.
- Cauda equina syndrome.
- Patients having Somatic referred pain.
- Specific diseases of spine like ankylosing spondylitis, ,vertebral collapse, Rheumatoid arthritis, and Spondylolisthesis.
- Tb spine, intermittent claudication,diabetic neuropathy.
- Recent infection.
- Mental retardation.
- Previous spinal Surgery.
- Pelvis Fracture.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Spinal Mobilization with Leg Movement (SMWLM) will be given as intervention to experimental group.
Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.
|
spinal mobilization with leg movement is the intervention given to experimental group.
This technique involves applying pressure to the relevant spinous process while the patient moves their limb through the previously restricted range of motion.
It is assumed that the restriction of movement is due to a spinal issue but it does not always indicate nerve damage as spinal movement is necessary for limb movement beyond a certain point.
The goal is to address any spinal mechanical limitations and there may also be potential effects on the nerves.
Participants will be given Hot pack for 15 minutes, TENS for 10 minutes
|
|
Active Comparator: Group B
The patients will be given Spinal mobilization (transverse glide) on the effected spinous process.
The total time duration will be 25-30 minutes.
Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.
|
Participants will be given Hot pack for 15 minutes, TENS for 10 minutes
The patients will be given Spinal mobilization transverse glide(kaltenborn glide) on the effected spinous process.
The total time duration will be 25-30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain severity
Time Frame: 2 weeks
|
Pain will be measured using Numeric Pain Rating Scale which is an eleven point scale scored from 0 indicating no pain and 10 indicating worst pain
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Straight leg raise
Time Frame: 2 weeks
|
Goniometer is a manual scale use for measuring the range of motion of a joint.
In this scale degree varies from 0-360 angle
|
2 weeks
|
|
Lumbar Disability
Time Frame: 2 weeks
|
Lumbar disability will be measured using Oswestry Disability Index which is a valid and reliable tool consisting of 10 items from which patient gets to choose according to their level of function
|
2 weeks
|
|
Cadence
Time Frame: 2 weeks
|
10 METER WALK TEST: Initial 2 meters of the gait and final 2 meters of the gait will be for acceleration and deceleration.
And the patient is then asking to walk and will assess the cadence and speed.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2023
Primary Completion (Estimated)
September 20, 2023
Study Completion (Estimated)
February 10, 2024
Study Registration Dates
First Submitted
July 9, 2023
First Submitted That Met QC Criteria
July 19, 2023
First Posted (Actual)
July 21, 2023
Study Record Updates
Last Update Posted (Actual)
July 21, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2023/13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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