- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02240303
Pain, Brain and Mobility Study (PBAM)
16 de fevereiro de 2016 atualizado por: University of Florida
Central and Peripheral Mechanisms Predicting Clinical Pain and Physical Performance in Older Adults
The aim of this project will be to document the central and peripheral mechanisms, which may predict clinical pain characteristics and associated physical performance in older adults.
Although chronic pain is common among older adults, there is limited understanding on the processing of pain and the mechanisms by which it affects physical function in these individuals.
The first aim of this study will be to examine predictors of clinical pain in older adults.
These will include a comprehensive somatosensory assessment battery including mechanical and thermal detection and pain thresholds in older adults with and without chronic pain.
The investigators will also assess basal cognitive and physical function to determine their associations with chronic pain.
Finally, brain structure and function will be assessed in these older adults with and without pain.
Visão geral do estudo
Status
Retirado
Condições
Descrição detalhada
The purpose of this research study is to learn more about how pain in older individuals changes the brain and impacts a person's mobility and function.
Pain is influenced by biology (like hormones), psychology (thoughts and feelings), and habits (like sleep or exercise) that may make older adults more likely to have higher or lower levels of pain.
Tipo de estudo
Observacional
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
65 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Older adults
Descrição
Inclusion Criteria:
- Age 65 years and older
- Willingness to participate in all study procedures
- Cognitively intact as defined by 3MS score > 80
Exclusion Criteria:
- Failure to provide informed consent;
- Contraindications to MRI, such as claustrophobia, heart pacemaker / defibrillator, heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system, cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal slivers in the orbital area/eye socket
- Active treatment for cancer or history of cancer in the past year
- Severe cardiac disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina;
- Previous stroke with upper and/or lower extremities involvement within the last 6 months
- History of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or severe neurological disorders likely to interfere with physical function
- Renal disease requiring dialysis
- Lung disease requiring steroids
- Inability to reliably rate pain intensity
- Current use of tobacco products
- Uncontrolled hypertension (BP of greater than 150/99 mm Hg)
- Serious systemic disease that restrict normal daily activities
- Neurological problems with significant changes in somatosensory and pain perception at the intended stimulation sites,
- Uncontrolled psychiatric condition (e.g., experiencing symptoms of schizophrenia, bipolar disorder, etc.) or hospitalization within the preceding year for psychiatric illness
- Daily use of narcotic medication
- Lower extremity amputation
- Uncontrolled diabetes (self-reported medication use and/or HA1C value)
- A known diagnosis of dementia
- Inability to communicate because of severe hearing loss or speech disorder;
- Severe visual impairment, which would preclude completion of the assessments and/or intervention.
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
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Chronic Pain Group
Participants that experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done.
In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
|
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Participants in both groups will have a Physical Performance test.
Participants in both groups will have an magnetic resonance imaging (MRI).
Participants in both groups will have blood samples taken.
|
|
No Chronic Pain Group
Participants that do not experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done.
In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
|
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Participants in both groups will have a Physical Performance test.
Participants in both groups will have an magnetic resonance imaging (MRI).
Participants in both groups will have blood samples taken.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Brain magnetic resonance imaging (MRI)
Prazo: Baseline and 12 months later
|
Differences in the MRI on the brain scans of participants with greater pain severity
|
Baseline and 12 months later
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Inflammatory markers in blood samples
Prazo: Baseline
|
To test the markers of pro-inflammatory (IL-1b, tumor necrosis factor (TNF-a)) and anti-inflammatory (IL-4, IL-10) with participants more sensitive to pain than the ones less sensitive to pain.
|
Baseline
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mobility (gait speed)
Prazo: Baseline and 12 months
|
Inverse dynamics will be used to calculate gait speed.
|
Baseline and 12 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yenisel Cruz-Almeida, MSPH, PhD, University of Florida
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 abril de 2015
Conclusão Primária (Real)
1 de abril de 2015
Conclusão do estudo (Real)
1 de abril de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
2 de setembro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de setembro de 2014
Primeira postagem (Estimativa)
15 de setembro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de fevereiro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de fevereiro de 2016
Última verificação
1 de fevereiro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 201400471
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 .