search
Back to results

Effects Of Spinal Mobilization With Leg Movement on Pain And Disability in Patients With Lumbar Radiculopathy

Primary Purpose

Lumbar Radiculopathy

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Spinal Mobilization With Leg Movement
Spinal Mobilization
Conventional treatment
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NCS University Rehabilitaion Centre Swabi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

pain severity
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

Secondary Outcome Measures

Straight leg raise
Goniometer is a manual scale use for measuring the range of motion of a joint. In this scale degree varies from 0-360 angle
Lumbar Disability
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
Cadence
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.

Full Information

First Posted
July 9, 2023
Last Updated
July 19, 2023
Sponsor
Foundation University Islamabad
search

1. Study Identification

Unique Protocol Identification Number
NCT05955781
Brief Title
Effects Of Spinal Mobilization With Leg Movement on Pain And Disability in Patients With Lumbar Radiculopathy
Official Title
Effects Of Spinal Mobilization With Leg Movement on Pain And Disability in Patients With Lumbar Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
February 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prallel Group Randomized Control Trial
Masking
Outcomes Assessor
Masking Description
A Single blinded study will be used in which data analyzer will be blind.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal Mobilization With Leg Movement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal Mobilization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional treatment
Intervention Description
Participants will be given Hot pack for 15 minutes, TENS for 10 minutes
Primary Outcome Measure Information:
Title
pain severity
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Straight leg raise
Description
Goniometer is a manual scale use for measuring the range of motion of a joint. In this scale degree varies from 0-360 angle
Time Frame
2 weeks
Title
Lumbar Disability
Description
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
Time Frame
2 weeks
Title
Cadence
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
NCS University Rehabilitaion Centre Swabi
City
Swabi
State/Province
KPK
ZIP/Postal Code
23430
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Effects Of Spinal Mobilization With Leg Movement on Pain And Disability in Patients With Lumbar Radiculopathy

We'll reach out to this number within 24 hrs