Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness
11 de septiembre de 2026 actualizado por: Žiga Kozinc, University of Primorska
Immediate Effect of Maitland Grade III++ Central Posteroanterior Mobilization on Erector Spinae and Multifidus Muscle Stiffness in Healthy Adults: A Randomized Crossover Trial
This randomized controlled crossover study will investigate the immediate effect of central posteroanterior lumbar mobilization on the intrinsic stiffness of the erector spinae and multifidus muscles in healthy adults without low back pain.
Twenty-four participants will complete two experimental visits in randomized order.
During one visit, participants will receive Maitland Grade III++ central posteroanterior mobilization at the L4 vertebral level, while during the other visit they will receive a sham mobilization condition involving gentle rhythmic pressure.
Muscle stiffness will be assessed using shear wave elastography immediately before and after each intervention.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
25
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: Žiga Kozinc, PhD
- Número de teléfono: +386 040161503
- Correo electrónico: ziga.kozinc@s2p.si
Ubicaciones de estudio
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Izola, Eslovenia, 6310
- Reclutamiento
- University of Primorska, Faculty of Health Sciences, Izola
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Contacto:
- Žiga Kozinc, PhD
- Número de teléfono: +386 040161503
- Correo electrónico: ziga.kozinc@s2p.si
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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
Sí
Descripción
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.
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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 activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Erector Spinae Muscle Stiffness
Periodo de tiempo: Immediately before and immediately after each intervention session
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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
Periodo de tiempo: Immediately before and immediately after each intervention session
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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.
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Immediately before and immediately after each intervention session
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Periodo de tiempo: 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
Periodo de tiempo: 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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
30 de septiembre de 2026
Finalización primaria (Estimado)
26 de noviembre de 2026
Finalización del estudio (Estimado)
30 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
11 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Publicado por primera vez (Actual)
17 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- UP-FHS-PA-SWE-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data underlying the results reported in subsequent publications may be made available upon reasonable request to the study investigators.
Data will be shared for scientifically justified purposes following approval by the investigators and, where appropriate, completion of a data-sharing agreement.
Marco de tiempo para compartir IPD
Data will be available following publication of the main study results and will remain available for at least 5 years.
Criterios de acceso compartido de IPD
Researchers with a scientifically justified proposal may request access.
Requests will be reviewed by the study investigators and data will be shared in de-identified form subject to applicable ethical and data-protection requirements.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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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