Manual Therapy Dosage Factorial Study
22 de setembro de 2015 atualizado por: McMaster University
This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology.
Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. The dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect.
All patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. All patient participants will receive supervised exercise and advice for the full 12 weeks. All patients will be provided with an instructional CD and exercise brochure to reinforce the whole program.
Follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).
Hypothesis: During recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.
Visão geral do estudo
Tipo de estudo
Intervencional
Estágio
- Fase 2
- Fase 3
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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Ontario
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Hamilton, Ontario, Canadá, L8S 1C7
- McMaster University
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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
21 anos a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days)
- pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache
- pain intensity must be at or above 30 mm on a 100 mm visual analogue scale
- must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months.
Exclusion Criteria:
- arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
- conditions that make the provision of neck exercise unsafe
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: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: A
Zero treatment/3 weeks
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Comparador Ativo: B
Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Comparador Ativo: C
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Comparador Ativo: D
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Comparador Ativo: F
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Comparador Ativo: G
Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Comparador Ativo: H
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Comparador Ativo: J
Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Comparador Ativo: K
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Comparador Ativo: L
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks
|
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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Sem intervenção: E
Zero treatment/6 weeks
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Sem intervenção: I
Zero treatment/12 weeks
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Quantitative Sensory Testing (QST)
Prazo: Within 24 weeks
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Within 24 weeks
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Current Perception Threshold (CPT)
Prazo: Within 24 weeks
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Within 24 weeks
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Neck Walk Index (NWI)
Prazo: Within 24 weeks
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Within 24 weeks
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Cyclical Reach and Grasp Test (CRGT)
Prazo: Within 24 weeks
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Within 24 weeks
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Muscle Biology (cytokine analyses)
Prazo: Within 24 weeks
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Within 24 weeks
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Central Breathing Control Test
Prazo: Within 24 weeks
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Within 24 weeks
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Neck Disability Index
Prazo: Within 24 weeks
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Within 24 weeks
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Pain Intensity - Visual Analogue Scale (VAS)
Prazo: Within 24 weeks
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Within 24 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Global Perceived Effect (GPE)
Prazo: Within 24 weeks
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Within 24 weeks
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Disabilities of the Arm, Shoulder, and Hand (DASH)
Prazo: Within 24 weeks
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Within 24 weeks
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Pain Threshold and Pain Tolerance Algometry
Prazo: Within 24 weeks
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Within 24 weeks
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Head Flexion Endurance
Prazo: Within 24 weeks
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Within 24 weeks
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Range of Motion
Prazo: Within 24 weeks
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Within 24 weeks
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Quality of Life (SF-36v2)
Prazo: within 24 weeks
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within 24 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Joy C MacDermid, PhD, McMaster University
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 de inscrição no estudo
Enviado pela primeira vez
19 de novembro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de novembro de 2007
Primeira postagem (Estimativa)
20 de novembro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
23 de setembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de setembro de 2015
Última verificação
1 de setembro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1 R21 AT004263
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