Exercise and Manipulative Therapy for Older Persons With Headache
26 de janeiro de 2016 atualizado por: Sureeporn Uthaikhup, Chiang Mai University
A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment
The presence of cervical musculoskeletal impairment is not specific to cervicogenic headache but other various frequent intermittent headache types (i.e.
migraine and tension-type headache) in the elderly population.
There has been no trial to date which has investigated the effectiveness of physiotherapy treatment specifically for older persons with various types of headache with associated neck pain and cervical musculoskeletal impairment.
Thus, the purpose of study investigate the efficacy of physiotherapy treatment for older persons who have headache concomitant with neck pain and musculoskeletal impairment
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Headache is a common health problem that affects quality of life in an older population and imposes substantial economic costs.
Headache changes with age.
Features of headache become less typical and neck pain is more frequently associated with headache in older persons.
We recently demonstrated that the presence of cervical musculoskeletal impairment is not specific to cervicogenic headache (headache caused by the neck).
Rather it was present in various frequent intermittent headache types in elders when compared to elders without headache.
Changes in headache characteristics with age play an important role not only in diagnosis but also in treatment choice.
Impairment in cervical musculoskeletal function found in older persons with headache has implications for headache management choices as the evidence indicates that physiotherapy management methods such as manual therapy and therapeutic exercise are an effective management approach for headache associated with the neck.
Physiotherapy treatment would be a safe therapeutic option and may have a beneficial effect for elders with headache who have neck pain and concomitant cervical musculoskeletal dysfunction.
This is particularly relevant as there are widespread concerns about medication overuse, adverse drug events and drug interactions in older persons.
The effective management of older persons with headache in particular of those with atypical features of headache remains a challenge.
Physiotherapy is indicated in those older persons diagnosed with cervicogenic headache but could also be adjunct treatment for those with cervical musculoskeletal signs who are suspected of having transitional headache.
At present, there has been no trial to date which has investigated the effectiveness of physiotherapy treatment specifically for older persons with various types of headache with associated neck pain and cervical musculoskeletal impairment.
A clinical trial of treatment of cervical musculoskeletal impairment in older persons with various headache types may help guide management of headache in attempts to lesson medication use and cost in this population.
Physiotherapy management may be a worthy treatment option particularly in older persons with headache who do not respond well to medication.
Tipo de estudo
Intervencional
Inscrição (Real)
65
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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Chiang Mai, Tailândia
- Department of Physical Therapy, Faculty of Associated Medical Sciences
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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
50 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Volunteers suffering from frequent intermittent headache (either migraine, tension-type headache or cervicogenic headache) at least one per month over a period of 3 months or longer
- Aged 50 years or older, female or male
- A score of ≥ 3/10 on visual analogue scale (VAS) of neck pain
- Evidence of cervical musculoskeletal impairment: restriction in active range of cervical motion in extension and rotation and join tenderness in at least one of the upper joint as detected by manual palpation
Exclusion Criteria:
- Headache diagnosed as following: temporal arteritis, trigeminal neuralgia, cluster headache, chronic paroxysmal hemicrania/hemicranias continua, temporomandibular joint dysfunction
- Other diagnosed disorders: cerebrovascular disease, Parkinson disease, cognitive disturbance
- Previous history of head or neck surgery
- Lack of willingness to receive either pragmatic treatment or usual care
- Physiotherapy or chiropractic treatment for headache in previous 6 months
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 Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Usual care intervention
Primary care as required including medication
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The usual care intervention will include appropriate primary care as required including medication
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Experimental: Physiotherapy treatment
Exercise and manipulative therapy
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Exercise and manipulative therapy treatment for 10 weeks:The treatment intervention consists of two visits per week for the first four weeks (8 treatments) and one visit per week for the last six weeks (6 treatments)
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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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Headache frequency
Prazo: Change from baseline in headache frequency at week 11 and 6 months after intervention
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The number of headache frequency in the past week
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Change from baseline in headache frequency at week 11 and 6 months after intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Headache intensity
Prazo: Change from baseline in headache intensity at week 11 and 6 months after intervention
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An average intensity in the past week will be rated on a 1-10 VAS
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Change from baseline in headache intensity at week 11 and 6 months after intervention
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Headache duration
Prazo: Change from baseline in headache duration at week 11 and 6 months after intervention
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The number of hours of headache in the past week
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Change from baseline in headache duration at week 11 and 6 months after intervention
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Neck pain intensity
Prazo: Change from baseline in neck pain intensity at week 11 and 6 months after intervention
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Intensity of neck pain will be measured using a 1-10 VAS
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Change from baseline in neck pain intensity at week 11 and 6 months after intervention
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Neck pain and disability
Prazo: Change from baseline in neck pain and disability at week 11 and 6 months after intervention
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Neck pain and disability will be measured using neck disability index (NDI-Thai version)
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Change from baseline in neck pain and disability at week 11 and 6 months after intervention
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Quality of life
Prazo: Change from baseline in quality of life at week 11 and 6 months after intervention
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The Quality of life will be measured using SF-36 (Thai version)
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Change from baseline in quality of life at week 11 and 6 months after intervention
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Medication intake
Prazo: Change from baseline in medication intake at week 11 and 6 months after intervention
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type and dose of all medications taken by subjects will be recorded one week at baseline and prior to follow-up points on a medication diary
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Change from baseline in medication intake at week 11 and 6 months after intervention
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Global assessment of treatment benefit
Prazo: Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
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Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)
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Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Sureeporn Uthaikhup, Ph.D., Department of Physical Therapy, Faculty of Associated Medical Sciences
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
1 de dezembro de 2012
Conclusão Primária (Real)
1 de dezembro de 2014
Conclusão do estudo (Real)
1 de julho de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
22 de novembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de novembro de 2012
Primeira postagem (Estimativa)
29 de novembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
28 de janeiro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de janeiro de 2016
Última verificação
1 de janeiro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MRG5580145
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 .
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