Efficacy of Combining Mulligan Spinal Mobilization With Leg Movement and Mechanical Lumbar Traction in Lumbar Radiculopathy
1 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
32
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Muhammad Haris, DPT
- Número de telefone: +92 349 5959672
- E-mail: drm.harispt@gmail.com
Estude backup de contato
- Nome: Dr Muhammad Mustafa, MSPT
- Número de telefone: +923339475130
- E-mail: contact@drmustafaclinics.com
Locais de estudo
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Capital
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Islamabad, Capital, Paquistão
- Recrutamento
- DMC Physiotherapy Clinic
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Contato:
- Dr Muhammad Mustafa, MSPT
- Número de telefone: +923339475130
- E-mail: contact@drmustafaclinics.com
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Contato:
- Muhammad Haris, DPT
- Número de telefone: +923495959672
- E-mail: drm.harispt@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: SMWLM + Mechanical Lumbar Traction + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM), mechanical lumbar traction, and conventional physiotherapy.
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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.
Outros nomes:
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.
Outros nomes:
All participants receive a standardized conventional therapy program consisting of:
Outros nomes:
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Comparador Ativo: SMWLM + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM) and conventional physiotherapy without mechanical traction.
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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.
Outros nomes:
All participants receive a standardized conventional therapy program consisting of:
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain Intensity
Prazo: Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)
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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.
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Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)
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Functional Disability
Prazo: Baseline, Week 2, Week 4
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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.
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Baseline, Week 2, Week 4
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Hip Range of Motion
Prazo: Baseline, Week 2, Week 4
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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.
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Baseline, Week 2, Week 4
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de abril de 2026
Conclusão Primária (Estimado)
15 de outubro de 2026
Conclusão do estudo (Estimado)
15 de novembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
1 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de maio de 2026
Primeira postagem (Real)
7 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Nervoso
- Doenças Neuromusculares
- Doenças do Sistema Nervoso Periférico
- Radiculopatia
- Terapêutica
- Modalidades de fisioterapia
- Atendimento ao paciente
- Reabilitação
- Cuidados posteriores
- Continuidade do atendimento ao paciente
- Anestesia e analgesia
- Terapia de estimulação elétrica
- Analgesia
- Terapia de exercícios
- Estimulação do nervo elétrico transcutâneo
Outros números de identificação do estudo
- KMU/DIR/CTU/2026/03
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Data will become available beginning 6 months after publication of the primary results and will remain available for 2 years.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .