Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction in Lumbar Spine Radiculopathy.
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction on Pain, Lumbar Mobility and Functional Disability in Patients With Lumbar Spine Radiculopathy.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Middle Age 25 to 50 years
- Both male and female of middle aged
- Subacute or chronic lumbar radiculopathy lasting 4 to 12 weeks
- Clinically diagnosed lumbar spine radiculopathy
- Pain radiating from lumbar region to the leg in one or more dermatomal distribution of the lumbosacral nerve root
- Moderate functional disability as indicated by Oswestry Disability Index (ODI) >20%
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Acute pain (<4 weeks)
- Contraindications to manual therapy or traction such as spinal instability
- significant musculoskeletal conditions, cerebrovascular accidents, psychiatric illness, or major systemic illness
- Neurological compromised, other radicular pain (e.g., piriformis syndrome, diabetic radiculopathy, vascular impingement of the sciatic nerve)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Spinal Mobilization With Leg Movement
|
Group A: Mulligan's spinal mobilization with leg movement with Conventional Therapy Patient Position: The participants were positioned in a side-lying position on their unaffected side, close to the edge of the treatment table.
Therapist Position: The affected leg was supported by therapist B and extended with a slight abduction of 10° at the hip and a knee flexion of 45°.Application of Technique: Therapist A applied and sustained a transverse glide of the spinous process toward the floor.
The participants actively moved the leg into the SLR with therapist B's assistance.
The L4 vertebra was selected if the participant had an L4/L5 lesion.
Therapist A carefully assisted the participants to perform active SLR in a gliding position with the help of therapist B to avoid symptom recurrence during movement.
If pain recurred, the participant was instructed to relax and hold the position for 3 s, and then return to the starting point(29).
|
|
Active Comparator: conventional therapy
5 minutes conventional therapy with patient education will be given to participants of both groups according to the severity of their condition along with allocated intervention.
This includes; directional preference exercises (e.g., McKenzie), core activation exercises, trunk and hip muscles strengthening and neurodynamic mobilization if nerve symptoms persist.
|
Group B: Mechanical Lumbar Traction with Conventional Therapy Patient Position: Patient position supine (lying on the back) with hips and knees flexed (pillows under the knees).
However, prone (lying on the stomach) positioning can also be utilized, particularly when the patient experiences discomfort or when targeting anterior structures of the spine.
Traction Technique: Mechanical lumbar traction is a technique that uses a machine to apply a controlled, distracting force to the lumbar spine.
This can help relieve pressure on the spinal nerves, reduce muscle spasms, and improve spinal alignment.
It's typically performed using a traction table and harnesses to gently pull the lower body away from the upper body.
Duration: For lumbar traction, sessions usually range from 20 to 30 minutes, with a frequency of several times per week(30).
Warm Up: 5minutes warm-up will be given before intervention to participants of both groups.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
numeric pain rating scale
Time Frame: Baseline to 4 weeks
|
NUMERIC PAIN RATING SCALE (NPRS) The Numeric Rating Scale (NRS) is a validated tool used to measure pain intensity.
Patients will be asked to rate their current pain severity on a scale from 0 to 10. Scoring can be obtained by calculating the mean score over a period of time or by tracking individual scores
|
Baseline to 4 weeks
|
|
Lumbar Mobility
Time Frame: Baseline to 4 weeks
|
OSWESTRY DISABILITY INDEX (ODI) The ODI is a ten-item questionnaire that assesses how back pain affects the patient's ability to perform daily activities of life (ADL).
It is a reliable and valid self-reported questionnaire that lasts 5 min for the patient to complete the measure and a few minutes for the examiner to calculate the scores.
Each item is scored from 0 to 5, and the summation of the ten scores is stated as a percentage of the maximum score; therefore, it ranges from 0 (no disability) to 100 (maximum disability)
|
Baseline to 4 weeks
|
|
Functional Disability
Time Frame: Baseline to 4 weeks
|
MODIFIED MODIFIED SCHOBER TEST (MMST) The Modified Modified Schober Test (MMST) is a clinical assessment of lumbar spine mobility where two marks are made on the patient's back-one at the midpoint between the posterior superior iliac spines (PSIS) and another 15 cm above it.
The patient then bends forward maximally, and the increase in distance between the marks is measured; a normal increase is ≥5 cm, while reduced expansion suggests restricted lumbar flexion, as seen in conditions like ankylosing spondylitis, degenerative disc disease, or radiculopathy.
|
Baseline to 4 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Tazeem Afzal, Ms, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- REC/RCR & AHS/25/0212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Lumbar Radiculopathy
-
NCT07448311CompletedLumbosacral Radiculopathy | Lumbar Radiculopathy Due to Spinal Nerve Compression | Lumbar Disc Prolapse With Radiculopathy | LUMBAR RADICULOPATHY
-
NCT07305792CompletedRadiculopathy Lumbar
-
NCT07222787RecruitingRadiculopathy Lumbar | Degenerative Lumbar Disc Disease
-
NCT05729022Not yet recruitingRadiculopathy Lumbar | Disc Disease Lumbar
-
NCT06421558RecruitingRadiculopathy Lumbar | Radiculopathy Sacral | Radiculopathy Multiple Sites
-
NCT07480252Not yet recruitingLumbar Radiculopathy
-
NCT07573124Recruiting
-
NCT07458399Not yet recruiting
-
NCT05793528Not yet recruitingLumbar Disc Herniation | Radiculopathy Lumbar
-
NCT04818606Recruiting
Clinical Trials on Spinal Mobilization With Leg Movement
-
NCT05955781Active, not recruiting
-
NCT07524686CompletedLow Back Pain | Lumbar Radiculopathy
-
NCT07328282Recruiting
-
NCT07050966Recruiting
-
NCT07042542CompletedCarpal Tunnel Syndrome
-
NCT06078033Completed
-
NCT02390336CompletedPathologic Processes | Musculoskeletal Diseases | Joint Disease | Osteoarthritis Hip
-
NCT07573124Recruiting
-
NCT04279756Completed
-
NCT04175184CompletedRotator Cuff Injuries | Shoulder Pain