Clinical trial NCT04990518: Physical Deconditioning in COVID-19 Positive Patients and Non-Specific Low Back Pain
Official title: Physical Deconditioning and Non-Specific Low Back Pain: the PHYDEL Study. A Prospective Study in a COVID-19 Positive Cohort
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Back Pain, Mechanical
Keywords: Low back pain
Physical deconditioning
Chronicity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with a positive COVID test during the previous year, living in Geneva Switzerland, who declare their willingness to participate in clinical studies.

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years, \<65 years old
* Confirmed or supected COVID19 test
* Informed Consent as documented by signature

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 1-year incidence of LBP
timeFrame: 1 year
measure: 1-year incidence of chronic LBP
timeFrame: 1 year
Secondary outcomes:
measure: Severity of LBP according to Pain trajectories
timeFrame: at least 3 months during the last year
measure: Severity of LBP according to multiaxial evaluation
timeFrame: 1 year
measure: Severity of LBP according to treatment use
timeFrame: 1 year
measure: Influence of depression on 1-year incidence of LBP
timeFrame: 1 year
measure: Influence of anxiety on 1-year incidence of LBP
timeFrame: 1 year
measure: Influence of catastrophism on 1-year incidence of LBP
timeFrame: 1 year
measure: Influence of fear-avoidance beliefs on 1-year incidence of LBP
timeFrame: 1 year
measure: Influence of self-efficacy on 1-year incidence of LBP
timeFrame: 1 year
measure: Influence of depression on 1-year incidence of chronic LBP
timeFrame: 1 year
measure: Influence of anxiety on 1-year incidence of chronic LBP
timeFrame: 1 year
measure: Influence of catastrophism on 1-year incidence of chronic LBP
timeFrame: 1 year
measure: Influence of fear-avoidance beliefs on 1-year incidence of chronic LBP
timeFrame: 1 year
measure: Influence of self-efficacy on 1-year incidence of chronic LBP
timeFrame: 1 year
measure: Influence of depression on severity of LBP accroding to pain trajectories
timeFrame: 1 year
measure: Influence of anxiety on severity of LBP accroding to pain trajectories
timeFrame: 1 year
measure: Influence of catastrophism on severity of LBP accroding to pain trajectories
timeFrame: 1 year
measure: Influence of fear-avoidance beliefs on severity of LBP accroding to pain trajectories
timeFrame: 1 year
measure: Influence of self-efficacy on severity of LBP accroding to pain trajectories
timeFrame: 1 year
measure: Influence of depression on severity of LBP assessed with a multiaxial tool
timeFrame: 1 year
measure: Influence of anxiety on severity of LBP assessed with a multiaxial tool
timeFrame: 1 year
measure: Influence of catastrophism on severity of LBP assessed with a multiaxial tool
timeFrame: 1 year
measure: Influence of fear-avoidance beliefs on severity of LBP assessed with a multiaxial tool
timeFrame: 1 year
measure: Influence of self-efficacy on severity of LBP assessed with a multiaxial tool
timeFrame: 1 year
measure: Influence of depression on severity of LBP according to treatment use
timeFrame: 1 year
measure: Influence of anxiety on severity of LBP according to treatment use
timeFrame: 1 year
measure: Influence of catastrophism on severity of LBP according to treatment use
timeFrame: 1 year
measure: Influence of fear-avoidance beliefs on severity of LBP according to treatment use
timeFrame: 1 year
measure: Influence of self-efficacy on severity of LBP according to treatment use
timeFrame: 1 year
measure: Impact of regular physical activity on LBP episode
timeFrame: 1 year
measure: Impact of regular physical activity on chronicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospitals of Geneva
name: Stephane Genevay, MD
role: PRINCIPAL_INVESTIGATOR
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