Lumbar Radiculopathy
Conditions
Keywords
Lumbar radiculopathy, Mulligan mobilization, Mechanical lumbar traction, Physical therapy, Randomized controlled trial
Brief summary
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.
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.
Interventions
PROCEDUREConventional Physical 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.
PROCEDUREMechanical Lumbar Traction
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.
PROCEDURESpinal Mobilization with Leg Movement (SMWLM)
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.
Sponsors
Khyber Medical University Peshawar
KMU-Institute of Health Sciences, Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No blinding is feasible given the nature of the physical interventions.
Intervention model description
Two-arm parallel-group design comparing an experimental group (SMWLM + mechanical lumbar traction + conventional therapy) with an active comparator group (SMWLM + conventional therapy).
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline, Week 2 (mid-intervention), Week 4 (post-intervention) | 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. |
| Functional Disability | 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. |
| Hip Range of Motion | Baseline, Week 2, Week 4 | 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. |
Countries
Pakistan
Contacts
CONTACTMuhammad Haris, DPT
CONTACTDr Muhammad Mustafa, MSPT
PRINCIPAL_INVESTIGATORMuhammad Haris, DPT
Institute of Health Science, Khyber Medical University Islamabad
PRINCIPAL_INVESTIGATORDr Muhammad Mustafa, MSPT
Institute of Health Science, Khyber Medical University Islamabad
PRINCIPAL_INVESTIGATORKinza Afzal, DPT
Hamdard University Islamabad Campus
Outcome results
None listed