Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis
20 de janeiro de 2020 atualizado por: Shin Kong Wu Ho-Su Memorial Hospital
To compare the effect of lumbar spinal manipulation, physical therapy and surgical management in the treatment of lumbar spinal stenosis.
Visão geral do estudo
Status
Rescindido
Intervenção / Tratamento
Descrição detalhada
Low back pain (LBP) is a very common health problem which results in negative impact in daily life and burden especially in elderly. The global age-standardized point prevalence of LBP in 2010 was estimated to be 9.4%. Among the etiologies of low back pain, lumbar spinal stenosis is frequently encountered by physicians. In a large observational study, the prevalence of lumbar spinal stenosis was 23.6% in the general population and higher in patients more than 60 years-old. If untreated, the symptoms may persist in 70% of the patients over the 48-month observation period. On the other hand, previous studies have shown that surgery is more effective in pain relief, neurological symptoms and further functional status, however, conservative treatment still had favorable effect in patients with milder symptoms.
The role of spinal manipulation has been discussed in previous study which compared the clinical efficacy of spinal manipulation against microdiskectomy in patients with sciatica secondary to lumbar disc herniation. According to this study, the pain, disability and life quality of both groups in 12-week period had no significant difference that chiropractic spinal manipulative treatment could be considered as a primary treatment. However, comparison among the effect of spinal manipulation, physical therapy, and surgery has not been conducted before. Therefore, the purpose of this study is to compare the effect of spinal manipulation, physical therapy, and surgery in the treatment of lumbar spinal stenosis.
Tipo de estudo
Intervencional
Inscrição (Real)
14
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Taipei, Taiwan
- ShinKongHospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age between 20 to 80 age years old
- Moderate to severe low back painand/or sciatica,and/or intermittent claudication (VAS>=4)
- Symptom duration is more than three months
- The diagnosis is proved by MRI
Exclusion Criteria:
- Serious spinal pathologies including spinal tumor, infection, andinflammatory disease
- Progressive weakness, sensory loss or symptoms and signs suggesting cauda equine esion
- Concomitant serious medical conditions
- History of spinal surgery before
- Severe osteoporosis or instability of the lumbar spine
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Lumbar spinal manipulation
Lumbar spinal manipulation will be performed up to 8 times within 1 month (no more than 2 times per week) by Dr. WangTso-Liang, who is a well-trained and experienced manual therapy doctor.
If the symptoms subside before the end of 1 month' treatment, the manipulation is discontinued.
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Comparador Ativo: Physical therapy
Physical therapy will include treatment with therapeutic exercise and modalities (lumbar traction, heattherapy, electric stimulation, and therapeutic exercise) for 2 month with frequency 3 times per week.
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Comparador Ativo: Surgery
General anesthesia, the patient will be put in the prone and abdomen-free position.
A 4-cm midline longitudinal incision will be made over the spinous processes of the L3-5 levels.
It will be deepened through the fat and fascia in line with the skin incision to reach the spinous processes.The paraspinous muscles will be dissected subperiosteally down the spinous processes and along the lamina to the facet joints.
Laminectomy will be done carefully at the herniated disc level for posterior decompression.
The ligamentum flavum will be excised to expose the dural sac.Using blunt dissection, the investigators carefully continue down the lateral side of the dura to the floor of the spinal canal; the investigators retract the dura and its nerve root medially.
After the posterior aspect of the disc space is revealed, the affected disc will be removed and discotomy will be performed.The wound will be closed in the routine fashion after meticulous hemostasis and normal saline irrigation.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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VAS pain score
Prazo: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Modified OswestryDisability Questionnaire (MODQ)
Prazo: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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For evaluation of disability related to LBP, Oswestry Disability Questionnaire (ODQ) is most widely used.
ODQ is a 10-item self report instrument that evaluates perceived disability in 10 areas: pain intensity, ability to lift objects, ability to walk, ability to sit, ability to stand, ability to sleep, sex life, social life, traveling, and ability to complete personal hygiene activities.
By using a 6-point Likert scale (0 = no limitation; 5 = severe limitation) , the total maximum scale is doubled and reported as a percentage of the patients perceived pain-related disability, with higher scores indicating greater disability.
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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Swiss Spinal Stenosis Questionnaire
Prazo: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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The Swiss Spinal Stenosis Questionnaire is a disease-specific self-report outcome instrument commonly used in patients with lumbar spinal stenosis (LSS) for evaluation of outcomes of the treatment.
It includes severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.
It was designed to complement existing generic measures of lumbar spine disability and health status in the evaluation of patients with LSS.
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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The Medical Outcome Survey Short Form (SF-36)
Prazo: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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The Medical Outcome Survey Short Form (SF-36) was used to assess general health status.
The SF-36 measures eight dimentions of health: general health perceptions, physical function, physical role, bodily pain, social functioning, mental health, emotional role, and vitality.
The eight scales may be combined into two summary scores, the physical component summary(PCS) and the mental component summary(MCS).
The SF-36 has well-established psychometric properties for the general population and individuals with LBP.
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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Intermittent claudication
Prazo: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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For evaluation of intermittent claudication, self-reported duration of walking will be recorded.
It divides into three levels to evaluate how long the patient can walk without resting.
The duration includes less than 10 minutes, 11-20 minutes, 21-30 minutes and more than 30 minutes.
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Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Lin-Fen Hsieh, M.D, Shin Kong Wu Ho-Su Memorial Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de janeiro de 2017
Conclusão Primária (Real)
1 de dezembro de 2019
Conclusão do estudo (Real)
1 de dezembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
7 de abril de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de abril de 2017
Primeira postagem (Real)
18 de abril de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de janeiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de janeiro de 2020
Última verificação
1 de janeiro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20160804R
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Indeciso
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