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

1 de mayo de 2026 actualizado por: Khyber Medical University Peshawar

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

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

32

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Muhammad Haris, DPT
  • Número de teléfono: +92 349 5959672
  • Correo electrónico: drm.harispt@gmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Pakistán
    • Capital
      • Islamabad, Capital, Pakistán
        • Reclutamiento
        • DMC Physiotherapy Clinic
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: SMWLM + Mechanical Lumbar Traction + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM), mechanical lumbar traction, and conventional physiotherapy.
Procedimiento: 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.
Otros nombres:
  • Mulligan mobilization, SMWLM, spinal mobilization with limb movement
Procedimiento: 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.
Otros nombres:
  • Intermittent lumbar traction, automatic traction therapy
Procedimiento: 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 performed daily, 3 sets of 10 repetitions, with progression as tolerated.
Otros nombres:
  • Standard physiotherapy, hot pack and TENS, therapeutic exercise
Comparador activo: SMWLM + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM) and conventional physiotherapy without mechanical traction.
Procedimiento: 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.
Otros nombres:
  • Mulligan mobilization, SMWLM, spinal mobilization with limb movement
Procedimiento: 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 performed daily, 3 sets of 10 repetitions, with progression as tolerated.
Otros nombres:
  • Standard physiotherapy, hot pack and TENS, therapeutic exercise

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Intensity
Periodo de tiempo: 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.
Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)
Functional Disability
Periodo de tiempo: 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.
Baseline, Week 2, Week 4
Hip Range of Motion
Periodo de tiempo: 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.
Baseline, Week 2, Week 4

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Khyber Medical University Peshawar

Colaboradores

KMU-Institute of Health Sciences, Islamabad

Investigadores

  • Investigador principal: Muhammad Haris, DPT, Institute of Health Science, Khyber Medical University Islamabad
  • Investigador principal: Dr Muhammad Mustafa, MSPT, Institute of Health Science, Khyber Medical University Islamabad
  • Investigador principal: Kinza Afzal, DPT, Hamdard University Islamabad Campus

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2026

Finalización primaria (Estimado)

15 de octubre de 2026

Finalización del estudio (Estimado)

15 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

1 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de mayo de 2026

Publicado por primera vez (Actual)

7 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KMU/DIR/CTU/2026/03

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

Data will become available beginning 6 months after publication of the primary results and will remain available for 2 years.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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