An interventional study of Spinal Mobilization with Leg Movement (SMWLM) and Mechanical Lumbar Traction in Lumbar Radiculopathy, sponsored by Khyber Medical University Peshawar. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Treatment
Lumbar radiculopathy (LR), often caused by disc herniation, results in significant pain, disability, and reduced quality of life. Spinal Mobilization with Leg Movement (SMWLM) is a manual technique that has shown promise, while mechanical lumbar traction is used to reduce nerve compression, though its standalone effectiveness is debated. This randomized controlled trial aims to compare the combined effect of SMWLM plus mechanical lumbar traction against SMWLM alone, both administered with conventional physiotherapy. Outcomes will be assessed over 4 weeks to determine if the combined intervention offers superior pain relief, functional improvement, and range of motion in patients with unilateral L4-L5 or L5-S1 radiculopathy.
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.
Exclusion Criteria:
Participants receive Spinal Mobilization with Leg Movement (SMWLM), mechanical lumbar traction, and conventional physiotherapy.
Procedure: Spinal Mobilization with Leg Movement (SMWLM) · Procedure: Mechanical Lumbar Traction · Procedure: Conventional Physical Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM) and conventional physiotherapy without mechanical traction.
Procedure: Spinal Mobilization with Leg Movement (SMWLM) · Procedure: Conventional Physical Therapy
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.
Also known as: Mulligan mobilization, SMWLM, spinal mobilization with limb movement
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.
Also known as: Intermittent lumbar traction, automatic traction therapy
All participants receive a standardized conventional therapy program consisting of: * Moist hot pack on the lumbar region for 10 minutes. * Transcutaneous electrical nerve stimulation (TENS) with 50-100 ms pulse width for 10 minutes, electrodes placed over the lumbar spine and affected lower limb. * Supervised therapeutic exercises: heel sitting (lumbar flexion), drawing-in maneuver, bridging, and pelvic tilting (2 sets of 5-7 repetitions per session). * Home exercise program: same exercises performed daily, 3 sets of 10 repetitions, with progression as tolerated.
Also known as: Standard physiotherapy, hot pack and TENS, therapeutic exercise
Pain Intensity
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.
Time frame: Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)
Functional Disability
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.
Time frame: Baseline, Week 2, Week 4
Hip Range of Motion
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.
Time frame: Baseline, Week 2, Week 4
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in published articles will be shared. This includes the demographic data, baseline characteristics, and all primary outcome measures (NPRS pain scores, Straight Leg Raise goniometry angles, and Modified Oswestry Disability scores) at the three assessment time points. The shared data will be accompanied by a data dictionary explaining all variable names and values.
Supporting information: Study protocol, Sap, Icf, Analytic code
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Khyber Medical University Peshawar