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| Name | Class |
|---|---|
| KMU-Institute of Health Sciences, Islamabad | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMWLM + Mechanical Lumbar Traction + Conventional Therapy | Experimental | Participants receive Spinal Mobilization with Leg Movement (SMWLM), mechanical lumbar traction, and conventional physiotherapy. |
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| SMWLM + Conventional Therapy | Active Comparator | Participants receive Spinal Mobilization with Leg Movement (SMWLM) and conventional physiotherapy without mechanical traction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Mobilization with Leg Movement (SMWLM) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, Week 2, Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Haris, DPT | Contact | +92 349 5959672 | drm.harispt@gmail.com | |
| Dr Muhammad Mustafa, MSPT | Contact | +923339475130 | contact@drmustafaclinics.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DMC Physiotherapy Clinic | Recruiting | Islamabad | Capital | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35735104 | Background | 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. | |
| 36208321 | Background | 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. |
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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.
Data will become available beginning 6 months after publication of the primary results and will remain available for 2 years.
Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator, Dr. Muhammad Haris, at drm.harispt@gmail.com. To gain access, data requestors must sign a data access agreement that includes commitments to use the data only for the specified research purpose, to maintain appropriate data security, and not to attempt to re-identify participants. A review of the proposal by the study team is required prior to approval.
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Two-arm parallel-group design comparing an experimental group (SMWLM + mechanical lumbar traction + conventional therapy) with an active comparator group (SMWLM + conventional therapy).
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No blinding is feasible given the nature of the physical interventions.
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| Mechanical Lumbar Traction | Procedure | 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. |
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| Conventional Physical Therapy | Procedure | All participants receive a standardized conventional therapy program consisting of:
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| Kinza Afzal, DPT | Hamdard University Islamabad Campus | Principal Investigator |
| 28192789 | Background | 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. |
| 33382419 | Background | 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. |
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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