- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07686237
Core Stability Training in Young Adults With Chronic Non-Specific Low Back Pain
Effects of Core Stability Training on Functional Recovery in Young Adults With Chronic Non-Specific Low Back Pain
Chronic non-specific low back pain is common among young adults and can lead to persistent pain, reduced physical function, decreased muscle strength, and impaired balance, affecting daily activities and quality of life. Core stability exercises are widely used in rehabilitation programs for low back pain, but the effectiveness of Swiss ball-based core stability training in young adults with chronic non-specific low back pain remains unclear.
The purpose of this study is to investigate whether Swiss ball-based core stability training can reduce pain and improve functional recovery in young men with chronic non-specific low back pain compared with conventional mat-based lumbar muscle exercises. Participants will be randomly assigned to either a Swiss ball core stability training group or a mat-based lumbar muscle training group and will complete a 6-week exercise intervention program.
The study will evaluate changes in pain intensity, disability related to low back pain, lumbar muscle strength, and dynamic balance ability. The study hypothesizes that Swiss ball-based core stability training will produce greater improvements in pain relief, physical function, muscle strength, and balance than conventional mat-based lumbar muscle exercises.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangxi
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Guilin, Guangxi, Porcelana, 541004
- Guangxi Normal University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Male participants aged 18 to 25 years.
- Diagnosis of chronic non-specific low back pain characterized by pain or discomfort located between the lower rib margin and the gluteal folds, with or without lower limb pain.
- No signs of nerve root compression and a negative straight leg raise test.
- No identifiable specific pathological or anatomical cause of low back pain.
- Baseline pain intensity score greater than 2 and less than 9 on the Visual Analog Scale (VAS).
- Duration of low back pain symptoms longer than 12 weeks.
- No treatment for low back pain received within the previous month.
- Willingness to participate in the study and provide written informed consent.
Exclusion Criteria:
- Failure to meet the diagnostic criteria for chronic non-specific low back pain.
- History of spinal trauma or spinal surgery.
- Presence of severe cardiovascular diseases, such as uncontrolled hypertension.
- Presence of severe metabolic diseases, such as gout.
- Presence of severe infectious diseases, such as pneumonia.
- Diagnosed structural spinal disorders, including lumbar disc herniation, spondylolisthesis, spinal stenosis, or other identifiable pathological anatomical abnormalities.
- Any medical condition that would prevent safe participation in the exercise intervention as determined by the investigators.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Swiss ball-based core stability training
Participants in this arm will perform core stability training using a Swiss ball as the primary exercise equipment.
Before the formal training session, participants will complete a 5-minute supervised warm-up consisting of dynamic stretching exercises focusing on the spine, shoulders, and hips, together with light running and jumping activities for the lower extremities.
The core stability program consists of six exercise components performed in a progressive sequence from easier to more difficult tasks, with gradual reductions in the base of support to increase instability and challenge trunk control.
As participants adapt to the intervention over time, the training load will be periodically increased to optimize therapeutic effects.
Following each training session, participants will complete 5 minutes of static stretching exercises as a cool-down activity.
|
Participants in this arm will perform core stability training using a Swiss ball as the primary exercise equipment.
Before the formal training session, participants will complete a 5-minute supervised warm-up consisting of dynamic stretching exercises focusing on the spine, shoulders, and hips, together with light running and jumping activities for the lower extremities.
The core stability program consists of six exercise components performed in a progressive sequence from easier to more difficult tasks, with gradual reductions in the base of support to increase instability and challenge trunk control.
As participants adapt to the intervention over time, the training load will be periodically increased to optimize therapeutic effects.
Following each training session, participants will complete 5 minutes of static stretching exercises as a cool-down activity.
|
|
Comparador activo: Mat-based lumbar muscle exercises
Participants in this arm will perform lumbar muscle exercises using a mat as the primary exercise surface.
Apart from the exercise equipment used, the overall training protocol will be identical to that of the Swiss ball-based core stability training group.
Before the formal training session, participants will complete the same 5-minute supervised warm-up program consisting of dynamic stretching exercises and light running and jumping activities.
After each training session, participants will also perform 5 minutes of static stretching exercises as a cool-down activity.
|
Participants in this arm will perform lumbar muscle exercises using a mat as the primary exercise surface.
Apart from the exercise equipment used, the overall training protocol will be identical to that of the Swiss ball-based core stability training group.
Before the formal training session, participants will complete the same 5-minute supervised warm-up program consisting of dynamic stretching exercises and light running and jumping activities.
After each training session, participants will also perform 5 minutes of static stretching exercises as a cool-down activity.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain intensity
Periodo de tiempo: From enrollment to the end of treatment at 6 weeks
|
Pain intensity will be assessed using the Visual Analog Scale (VAS).
Participants will rate their current level of low back pain on a 10-cm scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Higher scores indicate greater pain intensity.
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From enrollment to the end of treatment at 6 weeks
|
|
Low back disability
Periodo de tiempo: From enrollment to the end of treatment at 6 weeks
|
Low back-related disability will be assessed using the Oswestry Disability Index (ODI), a widely used measure of functional impairment associated with low back pain.
The questionnaire consists of 10 items evaluating the impact of low back pain on activities of daily living.
Each item is scored from 0 to 5, and the total score is converted into a percentage, with higher scores indicating greater disability.
|
From enrollment to the end of treatment at 6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lumbar muscle strength
Periodo de tiempo: From enrollment to the end of treatment at 6 weeks
|
Lumbar flexor and extensor muscle strength will be measured using a Hoggan MicroFET 2 handheld dynamometer.
Lumbar flexion strength will be assessed in the supine position, and lumbar extension strength will be assessed in the prone position.
Participants will perform maximal isometric contractions against the dynamometer for approximately 3 seconds.
Each test will be repeated five times, and the highest recorded value will be used for analysis.
Muscle strength values will be recorded in pounds (lb).
|
From enrollment to the end of treatment at 6 weeks
|
|
Dynamic balance ability
Periodo de tiempo: From enrollment to the end of treatment at 6 weeks
|
Dynamic balance ability will be assessed using the Y-Balance Test (YBT).
Participants will perform reach tasks in the anterior, posteromedial, and posterolateral directions while maintaining single-leg stance.
Reach distances will be normalized to lower limb length and expressed as a composite score percentage.
Higher scores indicate better dynamic balance performance.
|
From enrollment to the end of treatment at 6 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2018010748
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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