- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07573124
Efficacy of Combining Mulligan Spinal Mobilization With Leg Movement and Mechanical Lumbar Traction in Lumbar Radiculopathy
Efficacy of Combining Mulligan's Spinal Mobilization With Leg Movement Technique and Mechanical Lumbar Traction Among Patients With Lumbar Radiculopathy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Lumbar radiculopathy, commonly arising from disc herniation and nerve root compression, causes disabling leg pain, functional limitations, and reduced quality of life. Manual techniques such as Spinal Mobilization with Leg Movement (SMWLM) have shown promise, while mechanical lumbar traction aims to decrease nerve compression, though its added benefit remains uncertain. This randomized controlled trial will evaluate whether the combination of SMWLM and mechanical lumbar traction, delivered alongside conventional physiotherapy, yields superior clinical outcomes compared to SMWLM and conventional therapy alone. The study will be conducted in Islamabad, Pakistan, enrolling 32 adults aged 20-50 years with unilateral L4-L5 or L5-S1 radiculopathy (confirmed by MRI, symptom duration 4 weeks-6 months, positive Straight Leg Raise below 70°, and pain <7 on the Numeric Pain Rating Scale). Participants will be randomly allocated to either the experimental group (SMWLM + intermittent mechanical lumbar traction at 50% body weight + conventional therapy) or the control group (SMWLM + conventional therapy alone).
The intervention will be applied over four weeks (three sessions weekly for the first two weeks, then two sessions weekly). SMWLM involves a sustained transverse glide to the spinous process of the superior vertebra while the patient actively performs pain-free leg movement. Mechanical traction will be applied intermittently (30-second hold, 10-second rest) for 15 minutes per session. Conventional therapy includes hot pack, TENS, and a standardized exercise program. Primary outcomes include pain intensity (Numeric Pain Rating Scale), hip range of motion during Straight Leg Raise (universal goniometer), and functional disability (Modified Oswestry Low Back Pain Questionnaire) will be measured at baseline, week 2, and week 4. Data will be analyzed using repeated-measures ANOVA and independent t-tests to assess between-group differences. This trial will provide evidence on whether combining mechanical traction with SMWLM enhances pain relief, mobility, and function in lumbar radiculopathy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Haris, DPT
- Phone Number: +92 349 5959672
- Email: drm.harispt@gmail.com
Study Contact Backup
- Name: Dr Muhammad Mustafa, MSPT
- Phone Number: +923339475130
- Email: contact@drmustafaclinics.com
Study Locations
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-
Capital
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Islamabad, Capital, Pakistan
- Recruiting
- DMC Physiotherapy Clinic
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Contact:
- Dr Muhammad Mustafa, MSPT
- Phone Number: +923339475130
- Email: contact@drmustafaclinics.com
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Contact:
- Muhammad Haris, DPT
- Phone Number: +923495959672
- Email: drm.harispt@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 20-50 years
- Male and female participants
- Unilateral radiculopathy due to L4-L5 or L5-S1 disc bulge, confirmed by clinical examination and MRI
- Symptom duration of 4 weeks to 6 months
- Positive Straight Leg Raise (SLR) test on the affected leg (<70° of hip flexion)
- Pain intensity <7 on the Numeric Pain Rating Scale (NPRS; mild to moderate pain)
Exclusion Criteria:
- Cognitive impairment, dementia, central cord signs
- Inflammatory or degenerative spine conditions
- Spine surgery within the last 6 months
- Pregnant women in the later half of 2nd trimester or 3rd trimester
- Muscular involvement (e.g., Deep Gluteal syndrome, Piriformis syndrome)
- Currently receiving medications or other contemporaneous treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SMWLM + Mechanical Lumbar Traction + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM), mechanical lumbar traction, and conventional physiotherapy.
|
The therapist positions the patient side-lying on the unaffected side with the affected leg slightly abducted.
A sustained transverse manual glide is applied to the spinous process of the superior vertebra of the involved lumbar segment (e.g., L4 for an L4-L5 lesion).
Simultaneously, the patient actively lifts the leg into hip flexion and knee extension, ensuring the movement remains pain-free.
Dosage: 3 sets of 7-10 repetitions per treatment session.
Other Names:
Following SMWLM, the patient is placed supine in a Fowler position with hips and knees flexed to 90°, lower legs supported.
An intermittent distractive force (up to 50% of body weight) is delivered using an automatic traction device (e.g., PH-T3021).
The traction cycle consists of a 30-second hold and a 10-second rest, with a 1-minute ramp-up and ramp-down, for a total of 15 minutes.
Other Names:
All participants receive a standardized conventional therapy program consisting of:
Other Names:
|
|
Active Comparator: SMWLM + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM) and conventional physiotherapy without mechanical traction.
|
The therapist positions the patient side-lying on the unaffected side with the affected leg slightly abducted.
A sustained transverse manual glide is applied to the spinous process of the superior vertebra of the involved lumbar segment (e.g., L4 for an L4-L5 lesion).
Simultaneously, the patient actively lifts the leg into hip flexion and knee extension, ensuring the movement remains pain-free.
Dosage: 3 sets of 7-10 repetitions per treatment session.
Other Names:
All participants receive a standardized conventional therapy program consisting of:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)
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The average pain intensity (Numerical Pain Rating Scale) over the previous 24 hours is rated on an 11-point scale from 0 (no pain) to 10 (worst imaginable pain).
The patient is asked to provide current, best, and worst pain ratings; the mean of the three ratings will be used.
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Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)
|
|
Functional Disability
Time Frame: Baseline, Week 2, Week 4
|
Modified Oswestry Low Back Pain Questionnaire (MOLBPQ) is a validated 10-item questionnaire measuring how much low back pain has affected daily activities (e.g., walking, sitting, lifting, sleeping).
Each item scores 0-5; total sum is expressed as a percentage (0-50).
Higher scores indicate greater disability.
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Baseline, Week 2, Week 4
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Hip Range of Motion
Time Frame: Baseline, Week 2, Week 4
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Straight Leg Raise (SLR) Test is a pain-free hip flexion angle (in degrees) measured with a universal goniometer during the passive straight leg raise test.
The examiner stops the movement at the point where the patient first reports concordant radicular pain or tightness.
Standardized goniometer placement relative to the femur ensures consistency.
|
Baseline, Week 2, Week 4
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Muhammad Haris, DPT, Institute of Health Science, Khyber Medical University Islamabad
- Principal Investigator: Dr Muhammad Mustafa, MSPT, Institute of Health Science, Khyber Medical University Islamabad
- Principal Investigator: Kinza Afzal, DPT, Hamdard University Islamabad Campus
Publications and helpful links
General Publications
- Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
- Vanti C, Panizzolo A, Turone L, Guccione AA, Violante FS, Pillastrini P, Bertozzi L. Effectiveness of Mechanical Traction for Lumbar Radiculopathy: A Systematic Review and Meta-Analysis. Phys Ther. 2021 Mar 3;101(3):pzaa231. doi: 10.1093/ptj/pzaa231.
- Fourre A, Monnier F, Ris L, Telliez F, Michielsen J, Roussel N, Hage R. Low-back related leg pain: is the nerve guilty? How to differentiate the underlying pain mechanism. J Man Manip Ther. 2023 Apr;31(2):57-63. doi: 10.1080/10669817.2022.2092266. Epub 2022 Jun 23.
- Roberts KE, Beckenkamp PR, Ferreira ML, Duncan GE, Calais-Ferreira L, Gatt JM, Ferreira P. Positive lifestyle behaviours and emotional health factors are associated with low back pain resilience. Eur Spine J. 2022 Dec;31(12):3616-3626. doi: 10.1007/s00586-022-07404-7. Epub 2022 Oct 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Radiculopathy
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Anesthesia and Analgesia
- Electric Stimulation Therapy
- Analgesia
- Exercise Therapy
- Transcutaneous Electric Nerve Stimulation
Other Study ID Numbers
- KMU/DIR/CTU/2026/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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.
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