Physical Deconditioning and Non-Specific Low Back Pain: the PHYDEL Study. A Prospective Study in a COVID-19 Positive Cohort
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- 1-year incidence of LBP
研究概览
简要总结
The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 to explore the relationship between physical fitness and low back pain (LBP). Level of physical fitness will be measured at baseline and incidence and intensity of LBP will be recoreded over 1 year.
详细描述
Non-specific low back pain (LBP) is the worldwide number one cause for disease related years lived with disability. It is frequently assumed that a low physical fitness is a major risk factor for acute LBP as well as a factor for chronic LBP. However only few prospective observational study have been conducted.
The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 and assessing level of physical fitness and both incidence and intensity of LBP over a 1-year period.
The study aims to determine if a poor physical health, as measured by 6 minutes walk test (6MWT) and 30''seconds sit to stand test (30''STS), is a risk factor for LBP occurrence and for chronic LBP Secondary objectives aim to explore the respective weight of physical factors (i.e. physical fitness, BMI, smoking, physical activities) and psychological factors (i.e. depression, anxiety, catastrophism, fear-avoidance) on the occurrence and severity of LBP.
According to the literature, we expect that in the physically healthy population, 15% will developed back pain; whereas in the population in poor physical health the incidence at 1 year will be 30%. If alpha error is set at 0.05 then 236 patients are required to have a 80% chance to confirm our hypothesis. In order to account for drop out, and considering that the risk of drop out is high in this type of non-interventional study 350 persons will be recruited. Note that this amount of persons should yield approximately 70 persons with low back pain, which allow up to 7 independent variable in a logistic or cox regression. This is based on the rule of at least 10 events (low back pain) per variable.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years, <65 years old
- •Confirmed or supected COVID19 test
- •Informed Consent as documented by signature
排除标准
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- •Previous enrolment into the current study.
- •Any comorbidity which could impact on the physical test (6-minutes walking test), e.g hip or knee osteoarthritis, polyneuropathy, symptomatic coronary heart disease.
结局指标
主要结局
1-year incidence of LBP
时间窗: 1 year
Influence of baseline physical fitness on the number of participant with at least 1 episode of Low Back Pain
1-year incidence of chronic LBP
时间窗: 1 year
Influence of baseline physical fitness on the number of participant with at least 3 months of LBP most of the days
次要结局
- Influence of fear-avoidance beliefs on 1-year incidence of LBP(1 year)
- Influence of fear-avoidance beliefs on 1-year incidence of chronic LBP(1 year)
- Influence of depression on severity of LBP accroding to pain trajectories(1 year)
- Influence of anxiety on severity of LBP assessed with a multiaxial tool(1 year)
- Influence of fear-avoidance beliefs on severity of LBP assessed with a multiaxial tool(1 year)
- Severity of LBP according to multiaxial evaluation(1 year)
- Influence of depression on 1-year incidence of LBP(1 year)
- Influence of depression on 1-year incidence of chronic LBP(1 year)
- Influence of anxiety on 1-year incidence of chronic LBP(1 year)
- Influence of anxiety on severity of LBP accroding to pain trajectories(1 year)
- Severity of LBP according to Pain trajectories(at least 3 months during the last year)
- Influence of anxiety on 1-year incidence of LBP(1 year)
- Influence of self-efficacy on 1-year incidence of chronic LBP(1 year)
- Influence of fear-avoidance beliefs on severity of LBP accroding to pain trajectories(1 year)
- Influence of self-efficacy on severity of LBP accroding to pain trajectories(1 year)
- Influence of depression on severity of LBP assessed with a multiaxial tool(1 year)
- Influence of self-efficacy on 1-year incidence of LBP(1 year)
- Influence of catastrophism on 1-year incidence of chronic LBP(1 year)
- Influence of catastrophism on severity of LBP accroding to pain trajectories(1 year)
- Influence of catastrophism on severity of LBP assessed with a multiaxial tool(1 year)
- Severity of LBP according to treatment use(1 year)
- Influence of catastrophism on 1-year incidence of LBP(1 year)
- Influence of catastrophism on severity of LBP according to treatment use(1 year)
- Influence of self-efficacy on severity of LBP assessed with a multiaxial tool(1 year)
- Influence of depression on severity of LBP according to treatment use(1 year)
- Influence of self-efficacy on severity of LBP according to treatment use(1 year)
- Influence of anxiety on severity of LBP according to treatment use(1 year)
- Influence of fear-avoidance beliefs on severity of LBP according to treatment use(1 year)
- Impact of regular physical activity on LBP episode(1 year)
- Impact of regular physical activity on chronicity(1 year)
研究者
Stephane Genevay
Principal investigator
University Hospital, Geneva