Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients (CONFI-LOMB)
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|ClinicalTrials.gov Identifier: NCT04406363|
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
The current situation, linked to the pandemic of the new coronavirus SARS-CoV-2 generates health concerns, but is also accompanied by many other psychological, social, economic, professional, etc. consequences as well as numerous changes in behavior and lifestyles, notably due to confinement.
While the prevention of chronic low back pain and its management are primarily based on the practice of regular physical and sports activity, other psychological factors (stress, anxiety, depression), socioeconomic (low level of education, resources), professionals (physical workload, job dissatisfaction), etc. also have a major role in the onset and the persitence of low back pain.
Thus, it is to be supposed that the current context, and more particularly the confinement to which the population has been constrained for almost 2 months, have and will have notable consequences on the evolution of lumbar symptoms in chronic low back pain patients. However, the entanglement of different factors related to containment will potentially have different consequences depending on the individual. It therefore seems difficult to predict how the lumbar symptoms will develop in this population. Indeed, if it can imagined that the decrease in regular physical activity and the increase in anxiety in this context of insecurity could lead to an increase in pain, it could just as well consider that the decrease in stress work, strenuous physical work or travel time from work to home can, on the contrary, have a favorable effect.
The objective of this study is to assess the confinement effect on low back pain intensity in chronic low back pain patients.
This is an observational, descriptive, transversal and pluricentric study conducted by a single questionnaire.
|Condition or disease||Intervention/treatment|
|Chronic Low-back Pain||Other: non interventional|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients|
|Estimated Study Start Date :||June 2, 2020|
|Estimated Primary Completion Date :||June 2, 2020|
|Estimated Study Completion Date :||June 21, 2020|
- Other: non interventional
- Impact of confinement on the low back pain intensity [ Time Frame: at inclusion ]Proportion of subjects having a significant change in their low back pain intensity during confinement, defined by the items "much worse" and "moderately worse", or "much improved" and "moderately improved" respectively.The meaning of this significant change (worsening or improvement) will also be described.
- Correlation between confinement conditions and low back pain intensity [ Time Frame: at inclusion ]Change in low back pain intensity between before and during confinement evaluated by a numerical pain scale rated from 0 to 10 (0 = no pain ; 10 = worst imaginable pain). Confinement conditions (alone or in a group, space, etc.) and the practice of physical and sporting activities during confinement (weekly duration, etc.)
- Correlation between confinement conditions and disability related to low back pain [ Time Frame: at inclusion ]Disability measured by the "incapacity" sub-score of the "Core Outcome Measures Index" (COMI) questionnaire
- Correlation between infection with the new SARS-CoV-2 coronavirus and change in low back pain intensity [ Time Frame: at inclusion ]Occurrence of a SARS-CoV-2 infection and its level of severity (confirmed diagnosis, few or no symptoms, symptoms severely limiting daily activities, hospitalization in a conventional service or in intensive care)
- Correlation between confinement conditions and quality of life as well as psychological health [ Time Frame: at inclusion ]Quality of life and levels of anxiety and depression evaluated with the COMI-AD sub-score (modified version of the COMI integrating the state of psychological health);
- Impact of confinement on the use of care and the consumption of medication and psychoactive substances for low back pain [ Time Frame: at inclusion ]Use of care, drug consumption and psychoactive substances (tobacco, cannabis, alcohol, anxiolytics) for low back pain
- Correlation between working conditions and / or teleworking and low back pain intensity [ Time Frame: at inclusion ]Modalities of the the ocupational activity continuation (continuation of the activity, evolution of the working time, telework and modalities of establishment)
- Correlation between socio-economic factors and modalities as well as the experience of confinement [ Time Frame: at inclusion ]Experience of confinement. Socio-economic characteristics of the participants (age, sex, department, job and socio-professional category).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406363
|Angers, France, 49000|
|Contact: Audrey Petit, PhD 00 33 2 41 35 49 81 firstname.lastname@example.org|