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

NCT07573124 | Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2026/03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Radiculopathy

Keywords

Lumbar radiculopathy; Mulligan mobilization; Mechanical lumbar traction; Physical therapy; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

SMWLM + Mechanical Lumbar Traction + Conventional Therapy

EXPERIMENTAL

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

SMWLM + Conventional Therapy

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Intermittent lumbar traction, automatic traction therapy

SMWLM + Mechanical Lumbar Traction + Conventional Therapy

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.

Also known as: Mulligan mobilization, SMWLM, spinal mobilization with limb movement

SMWLM + Conventional Therapy; SMWLM + Mechanical Lumbar Traction + Conventional Therapy

Conventional Physical Therapy PROCEDURE

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

SMWLM + Conventional Therapy; SMWLM + Mechanical Lumbar Traction + Conventional Therapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• KMU-Institute of Health Sciences, Islamabad: collaborator

Study Sites (1)

DMC Physiotherapy Clinic

Islamabad, Capital, Pakistan

RECRUITING

Related Publications (4)

• 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 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.

  PMID: 36208321 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.

  PMID: 28192789 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.

  PMID: 33382419 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Haris, DPT

CONTACT

+92 349 5959672; drm.harispt@gmail.com

Dr Muhammad Mustafa, MSPT

CONTACT

+923339475130; contact@drmustafaclinics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding is feasible given the nature of the physical interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel-group design comparing an experimental group (SMWLM + mechanical lumbar traction + conventional therapy) with an active comparator group (SMWLM + conventional therapy).

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available beginning 6 months after publication of the primary results and will remain available for 2 years.
• Access Criteria: 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.

Locations

PA (1)