Efficacy of Combining Mulligan Spinal Mobilization With Leg Movement and Mechanical Lumbar Traction in Lumbar Radiculopathy

Official title

Efficacy of Combining Mulligan's Spinal Mobilization With Leg Movement Technique and Mechanical Lumbar Traction Among Patients With Lumbar Radiculopathy: A Randomized Controlled Trial

Overview

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

• Procedure Spinal 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.
• Procedure Mechanical 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.
• Procedure Conventional 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 pe

Primary outcome measures

• Pain Intensity [Time frame: Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)]
• Functional Disability [Time frame: Baseline, Week 2, Week 4]
• Hip Range of Motion [Time frame: Baseline, Week 2, Week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• DMC Physiotherapy Clinic — Islamabad

Publications

• 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. PMID 35735104
• 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. PMID 36208321
• 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/M16-23 PMID 28192789
• 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. PMID 33382419

Identifiers

NCT: NCT07573124 · KMU/DIR/CTU/2026/03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗