Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Low Back Pain
Type
Observational
Design
Observational Model: OtherTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

Description

Patients who consulted one of the study investigators (rheumatologist and algologist) for the management of a common chronic low back pain between January 1, 2020 and March 17, 2020 (begining of the French confinement) and who meet inclusion criteria will be offered to participate to the study. Elig...

Patients who consulted one of the study investigators (rheumatologist and algologist) for the management of a common chronic low back pain between January 1, 2020 and March 17, 2020 (begining of the French confinement) and who meet inclusion criteria will be offered to participate to the study. Eligible subjets will be preselected by the study investigators (from the medical file). The initial solicitation of a potential subject will be made by a phone contact by the investigator who treat him/her for his chronic low back pain. Subjects who agree to participate in the study will be offered to respond to a questionnaire by phone. The questionnaire (no more than 10 minutes) will assess the sociodemographic status, the confinement conditions, the new coranavirus infection status, changes in low back pain intensity during the confinement, incapacity related to low back pain, physical activities practice before and during the confinement, anxiety and depression, continuation of occupational activity and teleworking practice during the confienment . The main objective of this study is to assess the impact of confinement on change in low back pain intensity. The main endpoint is the proportion of subjects with a significant change in their low back pain during confinement, defined by the items "much worse" and "moderately worse", or "much improved" and "moderately improved" respectively. The secondary objectives are to assess: the association between the conditions of confinement and low back pain intensity; the association between the confinement conditions and disability related to low back pain; the association between infection with the new SARS-CoV-2 coronavirus and change in low back pain intensity; the association between the confinement conditions and the quality of life as well as the state of psychological health; the impact of confinement on the use of care and the consumption of medication and psychoactive substances for low back pain; the association between working conditions and / or teleworking and the low back pain intensity; the association between socio-economic factors and modalities as well as the experience of confinement. Given the exploratory nature of this study, the required number of subjects is empirically estimated at 350 subjects in total. Qualitative and quantitative data will be described (averages or percentages). A chi² test will be performed to compare the percentages between the different subgroups studied. A Student test will be carried out to compare the means between the different subgroups studied. An alpha risk of less than 5% will be considered significant. For each of the parameters of interest studied, the bivariate analysis may be supplemented by a multivariate analysis adapted to the criterion to be explained if the conditions of validity of this multivariate analysis are met.

Tracking Information

NCT #
NCT04406363
Collaborators
Not Provided
Investigators
Not Provided