- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07786402
Clinical Outcomes of Prone and Supine Lumbar Traction Matched to Mechanical Bias in Flexion and Extension Subgroups With Lumbosacral Radiculopathy
Clinical Outcomes of Prone and Supine Lumbar Traction Matched to Mechanical Bias in Flexion and Extension Subgroups With Lumbosacral Radiculopathy.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Atef abdulalim nadier, Assistant professor
- Número de telefone: +201003867064
- E-mail: a.nadier@ammanu.edu.jo
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Acute and subacute lumbosacral disc herniation with radiculopathy.
- Positive Straight leg raising test or Slump test.
Exclusion Criteria:
- Spondylolisthesis, prior spinal surgery, "Red Flags" (Cauda Equina, malignancy), or a non-mechanical response to repeated movements and patients with LBP without radiculopathy.
Plano de estudo
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: A) Extension bias, prone traction
Mechanical intermittent traction will done for 15 minutes with patient in prone position, after release the patient let wrest for 2 minutes then asked to walking for 1 minutes without immediate sitting post traction period. Prone on elbow press up exercise . Infrared radiation on back before traction |
Press up on elbow exercise traction from prone.
|
|
Experimental: B) Extension bias, supine traction
Mechanical intermittent traction will done for 15 minutes with patient in supine position, after release the patient let wrest for 2 minutes then asked to walking for 1 minutes without immediate sitting post traction period. Infrared on back before the traction. Press up on elbow exercise . |
Press up on elbow exercise.
traction from supine
|
|
Experimental: C) Flexion bias, supine traction
Mechanical intermittent traction will done for 15 minutes with patient in supine position(matches flexion bias), after release the patient let wrest for 2 minutes then asked to walking for 1 minutes without immediate sitting post traction period. Infrared on the back before the traction for 10 minutes. Knee to chest exercise for 2 minutes before the session . |
Traction from supine with flexion bias exercise knee to chest exercise for 2 minutes
|
|
Experimental: D) Flexion bias, prone traction
Mechanical intermittent traction will done for 15 minutes with patient in prone position(mismatches flexion bias), after release the patient let wrest for 2 minutes then asked to walking for 1 minutes without immediate sitting post traction period. Infrared on the back before the traction for 10 minutes. Knee to chest exercise for 2 minutes before the session . |
Traction from prone with flexion bias exercise knee to chest exercise for 2 minutes
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Numerical pain scale (NPRS)
Prazo: Pain intensity was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
Pain (lower limb radiating pain)
|
Pain intensity was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
|
Oswestry back scale (ODI)
Prazo: Patients completed the ODI questionnaire at baseline during their initial clinical evaluation. A subsequent assessment was conducted upon completion of the 12-session intervention protocol (representing the one-month follow-up)
|
Functional questionnaire for back disability
|
Patients completed the ODI questionnaire at baseline during their initial clinical evaluation. A subsequent assessment was conducted upon completion of the 12-session intervention protocol (representing the one-month follow-up)
|
|
Hip flexion Angle
Prazo: Hip flexion Angle was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
Hip flexion Angle during SLR test is also used to measure neural tension improvements for extension bias groups (by digital inclinometer)
|
Hip flexion Angle was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
|
Knee extension angle
Prazo: Knee extension angle was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
Knee extension angle with active knee extension during slump test was used for flexion bias groups (to measure how many degrees the knee is away from full extension when the leg pain starts).
|
Knee extension angle was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 1985
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .