- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07641972
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction in Lumbar Spine Radiculopathy.
10 de junho de 2026 atualizado por: Riphah International University
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction on Pain, Lumbar Mobility and Functional Disability in Patients With Lumbar Spine Radiculopathy.
Recruitment: Individuals with the lumbar spine radiculopathy diagnosis will undergo screening to determine their eligibility based on inclusion and exclusion criteria.
Eligible participants will be asked for their informed consent.
Enrollment: Participants will receive a unique identifying code to maintain confidentiality and be formally enrolled in the study upon obtaining informed consent.
Following that, they will have baseline evaluations for outcome factors such as numeric pain rating scale, Oswestry disability index, and modified-modified Schober test.
After completing the baseline evaluation, participants will be divided into two groups: Group A will receive the Mulligan's spinal mobilization with leg movement, while Group B will receive mechanical lumbar traction.
Every participant will get treatment for four weeks, with three sessions per week.
At the conclusion of the intervention period, a post-intervention assessment will be carried out.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
Recruitment: Individuals with the lumbar spine radiculopathy diagnosis will undergo screening to determine their eligibility based on inclusion and exclusion criteria.
Eligible participants will be asked for their informed consent.
Enrollment: Participants will receive a unique identifying code to maintain confidentiality and be formally enrolled in the study upon obtaining informed consent.
Following that, they will have baseline evaluations for outcome factors such as numeric pain rating scale, Oswestry disability index, and modified-modified Schober test.
After completing the baseline evaluation, participants will be divided into two groups: Group A will receive the Mulligan's spinal mobilization with leg movement, while Group B will receive mechanical lumbar traction.
Every participant will get treatment for four weeks, with three sessions per week.
At the conclusion of the intervention period, a post-intervention assessment will be carried out.
Randomization: Random allocation of participants into the two groups, Group A and Group B, will be performed by a lottery method.
The participants of Group A will be managed by Mulligan's spinal mobilization with leg movement while in Group B, participants will receive mechanical lumbar traction.
The physiotherapists will provide both interventions during a specified period.
Blindness: A single blinded study in which patients will be blinded.
Tipo de estudo
Intervencional
Inscrição (Real)
30
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.
Locais de estudo
-
-
Punjab Province
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Lahore, Punjab Province, Paquistão, 54000
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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:
- Middle Age 25 to 50 years
- Both male and female of middle aged
- Subacute or chronic lumbar radiculopathy lasting 4 to 12 weeks
- Clinically diagnosed lumbar spine radiculopathy
- Pain radiating from lumbar region to the leg in one or more dermatomal distribution of the lumbosacral nerve root
- Moderate functional disability as indicated by Oswestry Disability Index (ODI) >20%
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Acute pain (<4 weeks)
- Contraindications to manual therapy or traction such as spinal instability
- significant musculoskeletal conditions, cerebrovascular accidents, psychiatric illness, or major systemic illness
- Neurological compromised, other radicular pain (e.g., piriformis syndrome, diabetic radiculopathy, vascular impingement of the sciatic nerve)
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Spinal Mobilization With Leg Movement
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Group A: Mulligan's spinal mobilization with leg movement with Conventional Therapy Patient Position: The participants were positioned in a side-lying position on their unaffected side, close to the edge of the treatment table.
Therapist Position: The affected leg was supported by therapist B and extended with a slight abduction of 10° at the hip and a knee flexion of 45°.Application of Technique: Therapist A applied and sustained a transverse glide of the spinous process toward the floor.
The participants actively moved the leg into the SLR with therapist B's assistance.
The L4 vertebra was selected if the participant had an L4/L5 lesion.
Therapist A carefully assisted the participants to perform active SLR in a gliding position with the help of therapist B to avoid symptom recurrence during movement.
If pain recurred, the participant was instructed to relax and hold the position for 3 s, and then return to the starting point(29).
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Comparador Ativo: conventional therapy
5 minutes conventional therapy with patient education will be given to participants of both groups according to the severity of their condition along with allocated intervention.
This includes; directional preference exercises (e.g., McKenzie), core activation exercises, trunk and hip muscles strengthening and neurodynamic mobilization if nerve symptoms persist.
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Group B: Mechanical Lumbar Traction with Conventional Therapy Patient Position: Patient position supine (lying on the back) with hips and knees flexed (pillows under the knees).
However, prone (lying on the stomach) positioning can also be utilized, particularly when the patient experiences discomfort or when targeting anterior structures of the spine.
Traction Technique: Mechanical lumbar traction is a technique that uses a machine to apply a controlled, distracting force to the lumbar spine.
This can help relieve pressure on the spinal nerves, reduce muscle spasms, and improve spinal alignment.
It's typically performed using a traction table and harnesses to gently pull the lower body away from the upper body.
Duration: For lumbar traction, sessions usually range from 20 to 30 minutes, with a frequency of several times per week(30).
Warm Up: 5minutes warm-up will be given before intervention to participants of both groups.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
numeric pain rating scale
Prazo: Baseline to 4 weeks
|
NUMERIC PAIN RATING SCALE (NPRS) The Numeric Rating Scale (NRS) is a validated tool used to measure pain intensity.
Patients will be asked to rate their current pain severity on a scale from 0 to 10. Scoring can be obtained by calculating the mean score over a period of time or by tracking individual scores
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Baseline to 4 weeks
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Lumbar Mobility
Prazo: Baseline to 4 weeks
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OSWESTRY DISABILITY INDEX (ODI) The ODI is a ten-item questionnaire that assesses how back pain affects the patient's ability to perform daily activities of life (ADL).
It is a reliable and valid self-reported questionnaire that lasts 5 min for the patient to complete the measure and a few minutes for the examiner to calculate the scores.
Each item is scored from 0 to 5, and the summation of the ten scores is stated as a percentage of the maximum score; therefore, it ranges from 0 (no disability) to 100 (maximum disability)
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Baseline to 4 weeks
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Functional Disability
Prazo: Baseline to 4 weeks
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MODIFIED MODIFIED SCHOBER TEST (MMST) The Modified Modified Schober Test (MMST) is a clinical assessment of lumbar spine mobility where two marks are made on the patient's back-one at the midpoint between the posterior superior iliac spines (PSIS) and another 15 cm above it.
The patient then bends forward maximally, and the increase in distance between the marks is measured; a normal increase is ≥5 cm, while reduced expansion suggests restricted lumbar flexion, as seen in conditions like ankylosing spondylitis, degenerative disc disease, or radiculopathy.
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Baseline to 4 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Tazeem Afzal, Ms, Riphah International University
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)
2 de junho de 2025
Conclusão Primária (Estimado)
6 de agosto de 2026
Conclusão do estudo (Estimado)
4 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
8 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de junho de 2026
Primeira postagem (Real)
11 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- REC/RCR & AHS/25/0212
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
nill
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
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