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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07826260
Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness
Immediate Effect of Maitland Grade III++ Central Posteroanterior Mobilization on Erector Spinae and Multifidus Muscle Stiffness in Healthy Adults: A Randomized Crossover Trial
Visão geral do estudo
Status
Condições
Descrição detalhada
The study will be designed as a randomized controlled crossover trial to investigate the immediate effects of manual spinal mobilization on lumbar paraspinal muscle stiffness in healthy adults without low back pain. Each participant will attend two separate study visits and will receive both experimental conditions in a randomized order.
In the experimental condition, Maitland Grade III++ central posteroanterior mobilization will be applied over the spinous process of L4. The intervention will consist of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets. In the control condition, participants will receive a sham mobilization presented as a Grade I mobilization technique. The sham intervention will follow the same timing structure but will consist of gentle rhythmic pressure over the L4 spinous process.
Intrinsic muscle stiffness of the right erector spinae and multifidus muscles will be assessed using shear wave elastography. Three measurements will be obtained immediately before and after each intervention, and the mean value will be expressed in kilopascals. Measurements will be performed in a standardized prone position at the L4-L5 level.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Žiga Kozinc, PhD
- Número de telefone: +386 040161503
- E-mail: ziga.kozinc@s2p.si
Locais de estudo
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Izola, Eslovênia, 6310
- Recrutamento
- University of Primorska, Faculty of Health Sciences, Izola
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Contato:
- Žiga Kozinc, PhD
- Número de telefone: +386 040161503
- E-mail: ziga.kozinc@s2p.si
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Men and women aged 21 to 38 years.
- Resident of the Republic of Slovenia.
- No current low back pain.
- No contraindications to lumbar manual mobilization.
- Ability to assume and maintain the required prone testing position.
- Provision of written informed consent.
Exclusion Criteria:
- Current low back pain.
- Spondylolisthesis.
- Severe osteoporosis.
- Spinal stenosis.
- Lumboischialgia or other significant structural spinal deformity.
- Fibromyalgia.
- Recent spinal surgery or lumbar spinal fixation.
- Cauda equina syndrome.
- Nerve root compression associated with neurological deficits.
- Malignancy.
- Recent relevant trauma.
- Joint instability.
- Active rheumatoid arthritis.
- Acute local or systemic infection.
- Long-term local corticosteroid use.
- Inability to assume or maintain the required testing position.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Mobilization-Sham Sequence
Participants receive Maitland Grade III++ central posteroanterior mobilization during the first study visit and sham mobilization during the second study visit.
|
Central posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position.
The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total.
Sham mobilization is applied over the L4 spinous process with the participant in a prone position.
The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets.
The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided.
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Comparador Ativo: Sham-Mobilization Sequence
Participants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit.
|
Central posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position.
The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total.
Sham mobilization is applied over the L4 spinous process with the participant in a prone position.
The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets.
The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Erector Spinae Muscle Stiffness
Prazo: Immediately before and immediately after each intervention session
|
Intrinsic stiffness of the right erector spinae muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa).
Three measurements are obtained at each time point and averaged.
The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
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Immediately before and immediately after each intervention session
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Change in Multifidus Muscle Stiffness
Prazo: Immediately before and immediately after each intervention session
|
Intrinsic stiffness of the right multifidus muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa).
Three measurements are obtained at each time point and averaged.
The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
|
Immediately before and immediately after each intervention session
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Prazo: Immediately before and immediately after each intervention session
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Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the erector spinae shear wave elastography assessment.
Measurements will be performed immediately before and after each intervention condition.
The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.
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Immediately before and immediately after each intervention session
|
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Change in Multifidus Muscle Stiffness Assessed by Myotonometry
Prazo: Immediately before and immediately after each intervention session
|
Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the multifidus shear wave elastography assessment.
Measurements will be performed immediately before and after each intervention condition.
The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.
|
Immediately before and immediately after each intervention session
|
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
Palavras-chave
Outros números de identificação do estudo
- UP-FHS-PA-SWE-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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