Chronic Low-back PainCONFI-LOMBNCT04406363
Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients
An observational study of Chronic Low-back Pain, run by University Hospital, Angers at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- non interventional
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2020to 21 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who consulted one of the study inestigators (rheumatologist or algologist) for the management of common chronic low back pain between January 1, 2020 and March 17, 2020 inclusive and who meet the inclusion criteria.
Who may be able to join
- Major patients (men and women) with common chronic low back pain (i.e. without identified underlying cause)
- Patients who benefited from a consultation with a specialist doctor (rheumatologist or algologist) from the recruitment centers for common chronic low back pain between January 1, 2020 and March 17, 2020 (begining of the French confinement) included
- Patients who received information with non-opposition
Who cannot join
- Pain other than spinal pain not allowing to discriminate low back pain (fibromyalgia, chronic pain syndrome, etc.)
- Low back pain of secondary origin (infectious, tumor, fracture, inflammatory, etc.)
- Comorbidities limiting the practice of physical and sporting activities (severe heart or respiratory failure, arteriopathy of the lower limbs with lameness, etc.)
- Poor understanding of the French language
- Pregnant, lactating or parturient women
- Vulnerable adults within the meaning of the law
Show all 12Show fewer
- Person deprived of their liberty by judicial or administrative decision
- Person under psychiatric care under duress
- Person admitted to a health or social establishment for purposes other than that of research
- Person subject to a legal protection measure
- Person out of state to express consent
- Person opposed to participating in the research
Trial locations and contacts
1 site in 1 country.
France1 site
Petit
Angers, 49000
Audrey Petit, PhD, 00 33 2 41 35 49 81, aupetit@chu-angers.fr
About this study
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.
Read more
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.
Read the detailed 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.
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- non interventional
- Keywords
- confinement, chronic low back pain, changes in pain intensity, bio-psycho-social and occupational factors, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventionalOther
non interventional
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of confinement on the low back pain intensity
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.
Measured: at inclusion
Secondary outcomes (7)
Correlation between confinement conditions and low back pain intensity
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.)
Measured: at inclusion
Correlation between confinement conditions and disability related to low back pain
Disability measured by the "incapacity" sub-score of the "Core Outcome Measures Index" (COMI) questionnaire
Measured: at inclusion
Correlation between infection with the new SARS-CoV-2 coronavirus and change in low back pain intensity
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)
Measured: at inclusion
Correlation between confinement conditions and quality of life as well as psychological health
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);
Measured: at inclusion
Impact of confinement on the use of care and the consumption of medication and psychoactive substances for low back pain
Use of care, drug consumption and psychoactive substances (tobacco, cannabis, alcohol, anxiolytics) for low back pain
Measured: at inclusion
Correlation between working conditions and / or teleworking and low back pain intensity
Modalities of the the ocupational activity continuation (continuation of the activity, evolution of the working time, telework and modalities of establishment)
Measured: at inclusion
Correlation between socio-economic factors and modalities as well as the experience of confinement
Experience of confinement. Socio-economic characteristics of the participants (age, sex, department, job and socio-professional category).
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start2 Jun 2020 (estimated)
- Primary completion2 Jun 2020 (estimated)
- Study completion21 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406363
- Sponsor's protocol ID
- CONFI-LOMB
- Acronym
- CONFI-LOMB
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT04406363
- Acronym / sponsor ID
- CONFI-LOMB / CONFI-LOMB
- Conditions
- Chronic Low-back Pain
- Keywords
- confinement, chronic low back pain, changes in pain intensity, bio-psycho-social and occupational factors, physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 2 Jun 2020 (estimated)
- Primary completion
- 2 Jun 2020 (estimated)
- Study completion
- 21 Jun 2020 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who consulted one of the study inestigators (rheumatologist or algologist) for the management of common chronic low back pain between January 1, 2020 and March 17, 2020 inclusive and who meet the inclusion criteria.
Key inclusion criteria (3 listed)
- Major patients (men and women) with common chronic low back pain (i.e. without identified underlying cause)
- Patients who benefited from a consultation with a specialist doctor (rheumatologist or algologist) from the recruitment centers for common chronic low back pain between January 1, 2020 and March 17, 2020 (begining of the French confinement) included
- Patients who received information with non-opposition
Key exclusion criteria (12 listed)
- Pain other than spinal pain not allowing to discriminate low back pain (fibromyalgia, chronic pain syndrome, etc.)
- Low back pain of secondary origin (infectious, tumor, fracture, inflammatory, etc.)
- Comorbidities limiting the practice of physical and sporting activities (severe heart or respiratory failure, arteriopathy of the lower limbs with lameness, etc.)
- Poor understanding of the French language
- Pregnant, lactating or parturient women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventionalnon interventional | Other | – |
Primary outcome
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.
7 secondary outcomes
Correlation between confinement conditions and low back pain intensity
Time frame: at inclusion
Correlation between confinement conditions and disability related to low back pain
Time frame: at inclusion
Correlation between infection with the new SARS-CoV-2 coronavirus and change in low back pain intensity
Time frame: at inclusion
Correlation between confinement conditions and quality of life as well as psychological health
Time frame: at inclusion
Impact of confinement on the use of care and the consumption of medication and psychoactive substances for low back pain
Time frame: at inclusion
Correlation between working conditions and / or teleworking and low back pain intensity
Time frame: at inclusion
Correlation between socio-economic factors and modalities as well as the experience of confinement
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of confinement on the low back pain intensity (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.