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- Ensaio Clínico NCT05021718
Strengthening Exercise and Activities of Daily Living Instructions for Patients With Lumbar Disc Herniation
Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in Patients With Lumbar Disc Herniation
Lumbar disc herniation (LDH) is one of the most common causes of mechanical low back pain (LBP) associated with radiating leg pain. Conservative treatment, including exercise, analgesic, and physical therapy, is regarded as the first-line treatment of LDH.
This randomized clinical trial was conducted to evaluate the effectiveness of back and hip strengthening exercises combined with activities of daily living instructions (ADLIs) to reduce pain intensity in patients with LDH.
Visão geral do estudo
Status
Condições
Descrição detalhada
A total of 70 patients with LDH were randomly allocated to either the intervention group (IG) or the control group (CG). Patients in IG received different back and hip strengthening exercises five days a week for six weeks. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. In addition, the patients in both groups were instructed to follow the ADLIs during the intervention and at least 3 months after the intervention.
The straight leg raising (SLR) test and the Visual Analogue Scale (VAS) score were used to evaluate the patients' pain intensity. Outcomes were measured at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Chittagong, Bangladesh
- Chittagong Medical College Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age: 18 - 59 years.
- Clinically diagnosed LDH that was confirmed by MRI.
- Duration of the pain: ≥ 3 months
Exclusion Criteria:
- Painful spinal deformity
- Cauda equina syndrome
- Progressive neurological signs and/or muscle-wasting
- History of spinal surgery, spine fracture, scoliosis, tuberculosis, and tumours.
- Treated with epidural injections.
- Pregnancy
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 |
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Experimental: Intervention group (IG)
A total of 35 patients in IG received different back and hip strengthening exercises five times a week for six weeks.
They were also instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.
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Back and hip strengthening exercises.
The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.
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Comparador Ativo: Control group (CG)
The remaining 35 patients were allocated to CG.
The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks.
Moreover, they were instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.
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Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks
Hot moist compression from week 4 to week 6.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes in perceived pain intensity
Prazo: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
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Visual analog scale (VAS) score: Patients were asked to rate their perceived pain on a 0-to-10-point scale, where 0 indicated no pain at all and 10 indicated the most severe imaginable pain.
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Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes in the range of hip flexion during straight leg raising test
Prazo: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
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The range of hip flexion during affected and unaffected straight leg raising without pain was measured by hand-held goniometry.
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Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
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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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LDH exercise
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