Comparing Patient Reported Outcomes to Objective Measures of Function in Patients With Chronic Pain: Using the 2 Minute Walk Test and Elevation and Movement Lift Test, and Heart Rate Variability
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Heart Rate Variability
研究概览
简要总结
The Canadian Armed Forces (CAF) has limited data on baseline quality of life measures and objective measures of function, for active serving members with chronic pain. This study aims to collect this data using patient reported outcomes and 2 minute walk test (2MWT) while validating the newly created Elevation Movement Lift Off Test (EMLi) and correlating the data with heart rate variability (HRV) while comparing performance to healthy controls
详细描述
Objective The Canadian Armed Forces (CAF) has limited data on baseline quality of life measures and objective measures of function, for active serving members with chronic pain. This study aims to collect this data using patient reported outcomes and 2 minute walk test (2MWT) while validating the newly created Elevation Movement Lift Off Test (EMLi) and correlating the data with heart rate variability (HRV) while comparing performance to healthy controls.
Procedure Patients will complete pre-defined questionnaires on their pain condition, potential risk factors, and function. This data includes information on demographics, occupation, pain conditions and its impact on life, exercise levels, mood, childhood experiences, views on your condition and requests for care support. For patients and controls investigators will collect performance and heart rate measures while at rest, walking and lifting tests.
Risks and Mitigation Strategies Participation in this study is voluntary and volunteers can withdraw consent at any time without having any effect on access to future medical care.
Due to the nature of this study there are no significant associated risks. Any patients developing issues consistent with cardiopulmonary compromise will be treated according to the standard of care, stabilized and referred on for further evaluation.
The data collected will be stored in a locked Protected-B cabinet at the Canadian Forces Health Services Centre only and access will be restricted to the research team. The spreadsheet generated from this data will be password protected and anonymized. Only the research team will have access to this data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for patients male and female between 18 and 60 years old
- •seen within the CFO-P
- •diagnosed with one or more chronic pain condition
排除标准
- •adults who are unable to give their own consent
- •adults with uncontrolled mental health issues For Controls
- •Pacemaker/Cardiac Issues
- •SSRI/Beta Blocker/Anticholinergic medication use in controls
- •Migraine, cold medication, antihistamine, drugs use (ie cannabis <48hours)
- •Patients/controls will be asked
- •to bring exercise attire including running shoes,
- •not to drink alcohol within 24 hours of testing,
- •not to consume caffeinated products (ie energy drinks or tea/coffee) within 2 hours of the testing,
- •not to eat within 2 hours of testing,
- •not to participate in intense exercise for 24 hours before testing,
- •not to use nicotine products (smoke, vaping, and tobacco) in the 2 hours before testing,
- •not to use plant-based cannabis products 2 hours before testing
- •to use the bathroom before testing.
结局指标
主要结局
Heart Rate Variability
时间窗: baseline
Both sympathetic and parasympathetic nervous systems are involved in regulating pain states and may be disturbed in chronic pain. This disruption of the autonomic nervous system may be measured by variability of the interval between consecutive heart beats
次要结局
- 2 minute walk test (2MWT)(baseline)
- Elevation & Movement Lift test (EMLi)(baseline)
- Pain, Enjoyment and General Activity Scale (PEG)(baseline)
- The Pain Disability Index (PDI)(baseline)
研究者
Gaurav Gupta
Principal Investigator
Canadian Forces Health Services Centre Ottawa