Physical Deconditioning in COVID-19 Positive Patients and Non-Specific Low Back Pain
- Conditions
- Low Back Pain, Mechanical
- Registration Number
- NCT04990518
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 350
- Age > 18 years, <65 years old
- Confirmed or supected COVID19 test
- Informed Consent as documented by signature
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year incidence of LBP 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 1 year Influence of baseline physical fitness on the number of participant with at least 3 months of LBP most of the days
- Secondary Outcome Measures
Name Time Method Influence of fear-avoidance beliefs on 1-year incidence of LBP 1 year Influence of fear-avoidance beliefs as measured with FABQ on the incidence of LBP
Influence of fear-avoidance beliefs on 1-year incidence of chronic LBP 1 year Influence of fear-avoidance beliefs measured with FABQ on the incidence of people with LBP for more than 3 months
Influence of depression on severity of LBP accroding to pain trajectories 1 year Influence of depression as measured by HADS on 1 year pain trajectories recorded at the end of the study
Influence of anxiety on severity of LBP assessed with a multiaxial tool 1 year Influence of anxiety as measured by HADS on severity as assessed with COMI, multi-axial PRO specific for LBP
Severity of LBP according to multiaxial evaluation 1 year Influence of baseline physical fitness on Severity measured with COMI, multi-axial PRO specific for LBP
Influence of depression on 1-year incidence of LBP 1 year Influence of depression as measured with HADS on the incidence of LBP
Influence of depression on 1-year incidence of chronic LBP 1 year Influence of depression as measured with HADS on the incidence of people with LBP for more than 3 months
Influence of anxiety on 1-year incidence of chronic LBP 1 year Influence of anxiety as measured with HADS on the incidence of people with LBP for more than 3 months
Influence of anxiety on severity of LBP accroding to pain trajectories 1 year Influence of anxiety as measured by HADS on 1 year pain trajectories recorded at the end of the study
Influence of fear-avoidance beliefs on severity of LBP assessed with a multiaxial tool 1 year Influence of fear-avoidance beliefs as measured by FABQ on severity as assessed with COMI, multi-axial PRO specific for LBP
Severity of LBP according to Pain trajectories at least 3 months during the last year Influence of baseline physical fitness on 1 year pain trajectories recorded at the end of the study
Influence of anxiety on 1-year incidence of LBP 1 year Influence of anxiety as measured with HADS on the incidence of LBP
Influence of self-efficacy on 1-year incidence of chronic LBP 1 year Influence of self-efficacy measured with PSEQ-2 on the incidence of people with LBP for more than 3 months
Influence of fear-avoidance beliefs on severity of LBP accroding to pain trajectories 1 year Influence of fear-avoidance beliefs as measured with FABQ on 1 year pain trajectories recorded at the end of the study
Influence of self-efficacy on severity of LBP accroding to pain trajectories 1 year Influence of self-efficacy as measured with PSEQ-2 on 1 year pain trajectories recorded at the end of the study
Influence of depression on severity of LBP assessed with a multiaxial tool 1 year Influence of depression as measured by HADS on severity as assessed with COMI, multi-axial PRO specific for LBP
Influence of self-efficacy on 1-year incidence of LBP 1 year Influence of self-efficacy as measured with PSEQ-2 on the incidence of LBP
Influence of catastrophism on 1-year incidence of chronic LBP 1 year Influence of catastrophisms measured with PCS on the incidence of people with LBP for more than 3 months
Influence of catastrophism on severity of LBP accroding to pain trajectories 1 year Influence of catastrophism as measured by PCS on 1 year pain trajectories recorded at the end of the study
Influence of catastrophism on severity of LBP assessed with a multiaxial tool 1 year Influence of catastrophism as measured by PCS on severity as assessed with COMI, multi-axial PRO specific for LBP
Severity of LBP according to treatment use 1 year Influence of baseline physical fitness on the number of medical and paramedical appointements during the pain period
Influence of catastrophism on 1-year incidence of LBP 1 year Influence of catastrpphism as measured with PCS on the incidence of LBP
Influence of catastrophism on severity of LBP according to treatment use 1 year Influence of catastrophism as measured by PCS on the number of medical and paramedical appointements during the pain period
Influence of self-efficacy on severity of LBP assessed with a multiaxial tool 1 year Influence of self-efficacy as measured by PSEQ-2 on severity as assessed with COMI, multi-axial PRO specific for LBP
Influence of depression on severity of LBP according to treatment use 1 year Influence of depression as measured by HADS on the number of medical and paramedical appointements during the pain period
Influence of self-efficacy on severity of LBP according to treatment use 1 year Influence of self-efficacy measured by PSEQ-2 on the number of medical and paramedical appointements during the pain period
Influence of anxiety on severity of LBP according to treatment use 1 year Influence of anxiety as measured by HADS on the number of medical and paramedical appointements during the pain period
Influence of fear-avoidance beliefs on severity of LBP according to treatment use 1 year Influence of fear-avoidance beliefs measured by FABQ on the number of medical and paramedical appointements during the pain period
Impact of regular physical activity on LBP episode 1 year Studing the impact of the intensity of physical activity during the previous month on the length and the intensity (COMI) of LBP episode.
Impact of regular physical activity on chronicity 1 year Studing the impact of the intensity of physical activity during the previous month on the risk of chronicity (3 months of pain most of the day)
Trial Locations
- Locations (1)
Geneva University Hospital
🇨🇭Geneva, Switzerland