- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Guangxi
-
Guilin, Guangxi, China, 541004
- Guangxi Normal University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain intensity
Prazo: 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.
|
From enrollment to the end of treatment at 6 weeks
|
|
Low back disability
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Lumbar muscle strength
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- 2018010748
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 .