- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00942227
The Value of Traction in Treatment of Lumbar Radiculopathy
The Value of Traction in Treatment of Lumbar Radiculopathy.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these studies seem to indicate that traction interventions will be of little benefit when administered to large groups of patients without a prior attempt to select which patients are most likely to benefit, they are not sufficient to preclude the possibility that a subgroup of patients may benefit substantially from the intervention. Recent preliminary studies suggest a there exists a subgroup of patients with LBP that is likely to benefit from traction.
The two primary aims of this study are:
- Determine the validity of the previously-identified prediction criteria to identify patients highly likely to benefit from the addition of traction to a standard physical therapy intervention.
- Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84119
- Intermountain Healthcare, Rehab Agency
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report.
- Oswestry disability score of at least 20%
- Age at least 18 years and less than 60 years
At least one of the following signs of nerve root compression:
- Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees)
- Sensory deficit to pinprick on the ipsilateral lower extremity
- Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
- Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity
Exclusion Criteria:
- Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.)
- Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski)
- Patient reports the complete absence of low back and leg symptoms when seated
- Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis
- Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain
- Current pregnancy
- Inability to comply with the treatment schedule
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 |
---|---|
Comparador Ativo: Extension oriented treatment approach
Extension exercises.
Subjects are instructed in a progression of extension oriented movements for the lumbar spine.
Manual therapy may be added to further increase extension movement and/or reduction of symptoms.
|
Extension oriented exercises.
Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
Outros nomes:
Mechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine.
Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group.
Outros nomes:
|
Experimental: Mechanical traction plus extension-oriented treatment
Mechanical lumbar traction will be utilized in addition to extension oriented exercises.
Subjects are also instructed in a progression of extension oriented movements for the lumbar spine.
Manual therapy may be added to increase extension movement and/or reduce radicular symptoms.
|
Extension oriented exercises.
Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
Outros nomes:
Mechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine.
Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Oswestry Disability Index
Prazo: Baseline, 6 weeks, 6 months, 1year
|
Baseline, 6 weeks, 6 months, 1year
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Global Rating of Change
Prazo: Baseline, 6 weeks, 6 months, 1 year
|
Baseline, 6 weeks, 6 months, 1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julie M Fritz, PhD, Intermountain Healthcare; University of Utah
Publicações e links úteis
Publicações Gerais
- Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.
- Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale. BMC Musculoskelet Disord. 2010 Apr 30;11:81. doi: 10.1186/1471-2474-11-81.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- Doenças do Sistema Nervoso
- Dor
- Manifestações Neurológicas
- Neuropatia ciática
- Mononeuropatias
- Doenças do Sistema Nervoso Periférico
- Neuralgia
- Condições Patológicas, Anatômicas
- Doenças ósseas
- Hérnia
- Ciática
- Deslocamento do Disco Intervertebral
- Radiculopatia
- Doenças musculoesqueléticas
- Doenças da coluna vertebral
- Doenças Neuromusculares
Outros números de identificação do estudo
- 1008586
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 .
Ensaios clínicos em Physical therapy rehabilitation
-
University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalDesconhecido
-
Pamukkale UniversityConcluído
-
University of PennsylvaniaRescindidoInfecção Recorrente por Clostridium DifficileEstados Unidos
-
Azienda Ospedaliera Universitaria Integrata VeronaConcluído
-
University of Roma La SapienzaConcluídoFalha no implante dentário | Mucosite OralItália
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale...Concluído
-
NeuroTronik Inc.DesconhecidoInsuficiência Cardíaca AgudaPanamá
-
University of PennsylvaniaRescindidoInfecção Grave por Clostridium Difficile | Infecção Grave Complicada/Fulminante por Clostridium DifficileEstados Unidos
-
CellMedX CorporationNutrasource Pharmaceutical and Nutraceutical Services, Inc.Concluído
-
Columbia UniversityRescindido