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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07726823
Comparative Effects of Mulligan Bent Leg Raise Versus Spinal Mobilization With Leg Movement in Lumbar Radiculopathy
21 de julio de 2026 actualizado por: Riphah International University
Comparative Effects of Mulligan Bent Leg Raise Versus Spinal Mobilization With Leg Movement on Pain, Neural Mobility, Balance and Functional Disability in Lumbar Radiculopathy
Lumbar radiculopathy is a spinal nerve root disorder often caused by lumbar disc herniation or compression, leading to radiating leg pain, restricted movement, and functional difficulties.
This condition significantly disrupts daily activities and overall quality of life.
While medication and exercise are common treatments, manual therapy techniques are gaining recognition for their non-invasive and effective outcomes in relieving symptoms and improving patient function.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized clinical trial will be conducted in Physiotherapy outpatient department of Jinnah Hospital Lahore.
It will include 52 participants, aged 20 to 40 years, meeting clinical criteria for lumbar radiculopathy.
Participants will be selected from an outpatient physiotherapy department and assigned randomly into two equal groups.
Group A will receive the MBLR technique, while Group B will undergo the SMWLM technique.
Both interventions will be applied three times a week for four weeks under standardized protocols.
Key outcome measures include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), neural mobility evaluated through the Straight Leg Raise (SLR) and Slump Test, and functional status measured using the Oswestry Disability Index (ODI), Timed Up and Go (TUG) test, and 5 Repetition Sit-to-Stand test for postural balance.
Assessments will be conducted at baseline, after 2 weeks, at 4 weeks post-intervention, and at 8-week follow-up.
Data analysis will be done by SPSS version 25.
To ensure objectivity, all assessments will be conducted while keeping the patient unaware of their group assignment.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
52
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: Samrood Akram, PhD*
- Número de teléfono: 03324806143
- Correo electrónico: samrood.akram@riphah.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Amna Zia, PhD*
- Número de teléfono: 03244686993
- Correo electrónico: amna.zia@kemu.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Reclutamiento
- Femwell Physiocare Woman Rehab clinic
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Contacto:
- Arooj Fatima, MS-OMPT
- Número de teléfono: 03270056769
- Correo electrónico: draroohfahim@gmail.com
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-
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 to 40 years (26)
- Diagnosed patient with Unilateral Lumbar Radiculopathy secondary to L4/L5 and L5/S1 lumbar posterolateral disc buldge confirmed on MRI (12)
- Posterolateral Lumbar Radiculopathy
Exclusion Criteria:
• Presence of red flags (e.g., cauda equina syndrome, severe neurological deficits).
- Previous spinal surgery within 1 year.
- Severe osteoporosis or vertebral fractures.
- Pregnant women.
- Systemic inflammatory or autoimmune diseases.
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mulligan Bent Leg Raise (MBLR)
The Mulligan Bent Leg Raise (BLR) technique is a specialized physical therapy mobilization method used to relieve low back pain, reduce sciatica, and improve hamstring flexibility.
It involves applying gentle, pain-free traction while moving the leg through progressively greater ranges of hip flexion.
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Patient Position - Supine at edge of plinth
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Comparador activo: Spinal Mobilization with Leg Movement (SMWLM)
Spinal Mobilization with Leg Movement (SMWLM) is an advanced manual therapy technique developed as part of the Mulligan Concept.
It integrates manual joint mobilization with neurodynamic principles to treat lower back and radiating leg pain, most notably lumbar radiculopathy (sciatica)
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Patient Position - Side-lying on unaffected side near edge
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
NPRS for pain
Periodo de tiempo: upto 4 weeks
|
Pain intensity will be evaluated using the Numeric Pain Rating Scale, which ranges from 0 indicating "no pain" to 10 representing the "worst possible pain."
It has shown excellent test-retest reliability, with intraclass correlation coefficients (ICC) ranging between 0.95 and 0.98 in individuals with musculoskeletal conditions
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upto 4 weeks
|
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SLR and Slump test for neural mobility
Periodo de tiempo: Upto 4 weeks
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To assess neural mobility, the Straight Leg Raise and Slump Tests will be employed.
These are well-established clinical tools for identifying lumbar nerve root irritation.
The SLR test demonstrates strong diagnostic accuracy (~81%) and excellent inter-rater reliability with kappa values above 0.90 and aprox 0.71 for slump test
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Upto 4 weeks
|
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Oswestry Disability Index test for functional outcome
Periodo de tiempo: Upto 4 weeks
|
The ODI will be used to determine the level of functional disability associated with lower back pain.
It includes 10 items that assess various aspects of daily activity.
The tool has proven to be highly reliable (Cronbach's alpha = 0.87) and valid across different patient populations with lumbar spine conditions
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Upto 4 weeks
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Time up and go (TUG) test for functional outcome
Periodo de tiempo: Upto 4 weeks
|
Balance and functional mobility will be measured using the TUG test, which involves timing a patient as they rise from a chair, walk three meters, turn, return, and sit down.
This test is highly reliable (ICC = 0.82 to 0.99) and shows good concurrent validity in both spinal and geriatric populations (34).
The cutoff value for balance and functional mobility TUG test is 7.2 sec
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Upto 4 weeks
|
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Five repetition sit to stand test
Periodo de tiempo: upto 4 weeks
|
The 5 Rep Sit-to-Stand Test will be used to assess lower limb strength and functional performance.
The patient gets to their maximum standing position and then sits back down five times as fast as they can without the use of their hands or arms.
It has demonstrated excellent reliability (ICC > 0.90) and shows strong correlation with functional ability (36).
The cutoff value is > 10 sec for 5 rep sitting to standing and standing to sitting transition
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upto 4 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Amna Zia, PhD, King Edward Medical University
- Investigador principal: Muniba Tahir, Riphah International University, Lahore 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
- George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
- Senol D, Erdem C, Canbolat M, Toy S, Karatas T, Baykara RA, Ozbag D, Akyurek G. Comparison of the effects of conventional physiotherapy and proprioception exercises on pain and ankle proprioception in patients with lumbar radiculopathy. J Back Musculoskelet Rehabil. 2022;35(2):421-428. doi: 10.3233/BMR-200361.
- Ashraf B, Ahmad S, Ashraf K, Kanwal S, Ashraf S, Khan N, et al. Effectiveness of spinal mobilization with leg movement versus McKenzie back extension exercises in lumbar radiculopathy. 2021;15(5):1436-40.
- Fatima A, Mehmood Z, Ahmad SJJoIIMC. Effects of Mulligan Traction Straight Leg Raise Versus Passive Straight Leg Raise in Lumbar Radiculopathy Patients. 2022;17(2):86-90.
- Singh V, Malik MJRJoN. Lumbar radiculopathy managed with spinal mobilization with leg movement: A case study. 2021;20(2):246-9.
- Naidu SP, Srikantaiah S, Boyle RJIJoPT, Research. Immediate Effect of Mulligan's Spinal Mobilization with Limb Movements on Straight Leg Raise Test in Patients with Lumbar Radiculopathy: A Randomized Controlled Trial. 2023;5(1):66-72.
- Singh V, Malik MJAiR. Effect of manual therapy on pain, disability and neural mobility in patients of lumbar prolapsed intervertebral disc: a randomized controlled trial. 2022;36(3):11-8.
- Yasmeen S, Ahmad Z, Ishtiaq NJJRCoRS. The comparative effects of Butler's neural tissue mobilization and Mulligan's Bent leg raise in patients with chronic lumbar radiculopathy. 2022;10(02).
- Lin LH, Lin TY, Chang KV, Wu WT, Ozcakar L. Neural Mobilization for Reducing Pain and Disability in Patients with Lumbar Radiculopathy: A Systematic Review and Meta-Analysis. Life (Basel). 2023 Nov 26;13(12):2255. doi: 10.3390/life13122255.
- Hussein H, Atteya M, Ansari A, Kamel E. A Systematic Review and Meta-Analysis of the Effectiveness of Mulligan Mobilization with Movement on Pain, Range of Motion, Function, and Flexibility in Patients with Sciatica. NeuroRehabilitation. 2025 Mar;56(2):83-96. doi: 10.1177/10538135241301693. Epub 2024 Dec 18.
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)
20 de junio de 2026
Finalización primaria (Estimado)
20 de agosto de 2026
Finalización del estudio (Estimado)
20 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2026
Publicado por primera vez (Actual)
24 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC/RCR&AHS/25/0132 Muniba
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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