<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04406363</url>
  </required_header>
  <id_info>
    <org_study_id>CONFI-LOMB</org_study_id>
    <nct_id>NCT04406363</nct_id>
  </id_info>
  <brief_title>Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients</brief_title>
  <acronym>CONFI-LOMB</acronym>
  <official_title>Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current situation, linked to the pandemic of the new coronavirus SARS-CoV-2 generates&#xD;
      health concerns, but is also accompanied by many other psychological, social, economic,&#xD;
      professional, etc. consequences as well as numerous changes in behavior and lifestyles,&#xD;
      notably due to confinement.&#xD;
&#xD;
      While the prevention of chronic low back pain and its management are primarily based on the&#xD;
      practice of regular physical and sports activity, other psychological factors (stress,&#xD;
      anxiety, depression), socioeconomic (low level of education, resources), professionals&#xD;
      (physical workload, job dissatisfaction), etc. also have a major role in the onset and the&#xD;
      persitence of low back pain.&#xD;
&#xD;
      Thus, it is to be supposed that the current context, and more particularly the confinement to&#xD;
      which the population has been constrained for almost 2 months, have and will have notable&#xD;
      consequences on the evolution of lumbar symptoms in chronic low back pain patients. However,&#xD;
      the entanglement of different factors related to containment will potentially have different&#xD;
      consequences depending on the individual. It therefore seems difficult to predict how the&#xD;
      lumbar symptoms will develop in this population. Indeed, if it can imagined that the decrease&#xD;
      in regular physical activity and the increase in anxiety in this context of insecurity could&#xD;
      lead to an increase in pain, it could just as well consider that the decrease in stress work,&#xD;
      strenuous physical work or travel time from work to home can, on the contrary, have a&#xD;
      favorable effect.&#xD;
&#xD;
      The objective of this study is to assess the confinement effect on low back pain intensity in&#xD;
      chronic low back pain patients.&#xD;
&#xD;
      This is an observational, descriptive, transversal and pluricentric study conducted by a&#xD;
      single questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who consulted one of the study investigators (rheumatologist and algologist) for the&#xD;
      management of a common chronic low back pain between January 1, 2020 and March 17, 2020&#xD;
      (begining of the French confinement) and who meet inclusion criteria will be offered to&#xD;
      participate to the study.&#xD;
&#xD;
      Eligible subjets will be preselected by the study investigators (from the medical file). The&#xD;
      initial solicitation of a potential subject will be made by a phone contact by the&#xD;
      investigator who treat him/her for his chronic low back pain. Subjects who agree to&#xD;
      participate in the study will be offered to respond to a questionnaire by phone.&#xD;
&#xD;
      The questionnaire (no more than 10 minutes) will assess the sociodemographic status, the&#xD;
      confinement conditions, the new coranavirus infection status, changes in low back pain&#xD;
      intensity during the confinement, incapacity related to low back pain, physical activities&#xD;
      practice before and during the confinement, anxiety and depression, continuation of&#xD;
      occupational activity and teleworking practice during the confienment .&#xD;
&#xD;
      The main objective of this study is to assess the impact of confinement on change in low back&#xD;
      pain intensity. The main endpoint is the proportion of subjects with a significant change in&#xD;
      their low back pain during confinement, defined by the items &quot;much worse&quot; and &quot;moderately&#xD;
      worse&quot;, or &quot;much improved&quot; and &quot;moderately improved&quot; respectively.&#xD;
&#xD;
      The secondary objectives are to assess:&#xD;
&#xD;
        1. the association between the conditions of confinement and low back pain intensity;&#xD;
&#xD;
        2. the association between the confinement conditions and disability related to low back&#xD;
           pain;&#xD;
&#xD;
        3. the association between infection with the new SARS-CoV-2 coronavirus and change in low&#xD;
           back pain intensity;&#xD;
&#xD;
        4. the association between the confinement conditions and the quality of life as well as&#xD;
           the state of psychological health;&#xD;
&#xD;
        5. the impact of confinement on the use of care and the consumption of medication and&#xD;
           psychoactive substances for low back pain;&#xD;
&#xD;
        6. the association between working conditions and / or teleworking and the low back pain&#xD;
           intensity;&#xD;
&#xD;
        7. the association between socio-economic factors and modalities as well as the experience&#xD;
           of confinement.&#xD;
&#xD;
      Given the exploratory nature of this study, the required number of subjects is empirically&#xD;
      estimated at 350 subjects in total.&#xD;
&#xD;
      Qualitative and quantitative data will be described (averages or percentages). A chi² test&#xD;
      will be performed to compare the percentages between the different subgroups studied. A&#xD;
      Student test will be carried out to compare the means between the different subgroups&#xD;
      studied. An alpha risk of less than 5% will be considered significant.&#xD;
&#xD;
      For each of the parameters of interest studied, the bivariate analysis may be supplemented by&#xD;
      a multivariate analysis adapted to the criterion to be explained if the conditions of&#xD;
      validity of this multivariate analysis are met.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2, 2020</start_date>
  <completion_date type="Anticipated">June 21, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of confinement on the low back pain intensity</measure>
    <time_frame>at inclusion</time_frame>
    <description>Proportion of subjects having a significant change in their low back pain intensity during confinement, defined by the items &quot;much worse&quot; and &quot;moderately worse&quot;, or &quot;much improved&quot; and &quot;moderately improved&quot; respectively.The meaning of this significant change (worsening or improvement) will also be described.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between confinement conditions and low back pain intensity</measure>
    <time_frame>at inclusion</time_frame>
    <description>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.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between confinement conditions and disability related to low back pain</measure>
    <time_frame>at inclusion</time_frame>
    <description>Disability measured by the &quot;incapacity&quot; sub-score of the &quot;Core Outcome Measures Index&quot; (COMI) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between infection with the new SARS-CoV-2 coronavirus and change in low back pain intensity</measure>
    <time_frame>at inclusion</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between confinement conditions and quality of life as well as psychological health</measure>
    <time_frame>at inclusion</time_frame>
    <description>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);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of confinement on the use of care and the consumption of medication and psychoactive substances for low back pain</measure>
    <time_frame>at inclusion</time_frame>
    <description>Use of care, drug consumption and psychoactive substances (tobacco, cannabis, alcohol, anxiolytics) for low back pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between working conditions and / or teleworking and low back pain intensity</measure>
    <time_frame>at inclusion</time_frame>
    <description>Modalities of the the ocupational activity continuation (continuation of the activity, evolution of the working time, telework and modalities of establishment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between socio-economic factors and modalities as well as the experience of confinement</measure>
    <time_frame>at inclusion</time_frame>
    <description>Experience of confinement. Socio-economic characteristics of the participants (age, sex, department, job and socio-professional category).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Chronic Low-back Pain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non interventional</intervention_name>
    <description>non interventional</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who consulted one of the study inestigators (rheumatologist or algologist) for the&#xD;
        management of common chronic low back pain between January 1, 2020 and March 17, 2020&#xD;
        inclusive and who meet the inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients (men and women) with common chronic low back pain (i.e. without&#xD;
             identified underlying cause)&#xD;
&#xD;
          -  Patients who benefited from a consultation with a specialist doctor (rheumatologist or&#xD;
             algologist) from the recruitment centers for common chronic low back pain between&#xD;
             January 1, 2020 and March 17, 2020 (begining of the French confinement) included&#xD;
&#xD;
          -  Patients who received information with non-opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pain other than spinal pain not allowing to discriminate low back pain (fibromyalgia,&#xD;
             chronic pain syndrome, etc.)&#xD;
&#xD;
          -  Low back pain of secondary origin (infectious, tumor, fracture, inflammatory, etc.)&#xD;
&#xD;
          -  Comorbidities limiting the practice of physical and sporting activities (severe heart&#xD;
             or respiratory failure, arteriopathy of the lower limbs with lameness, etc.)&#xD;
&#xD;
          -  Poor understanding of the French language&#xD;
&#xD;
          -  Pregnant, lactating or parturient women&#xD;
&#xD;
          -  Vulnerable adults within the meaning of the law&#xD;
&#xD;
          -  Person deprived of their liberty by judicial or administrative decision&#xD;
&#xD;
          -  Person under psychiatric care under duress&#xD;
&#xD;
          -  Person admitted to a health or social establishment for purposes other than that of&#xD;
             research&#xD;
&#xD;
          -  Person subject to a legal protection measure&#xD;
&#xD;
          -  Person out of state to express consent&#xD;
&#xD;
          -  Person opposed to participating in the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Petit</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Audrey Petit, PhD</last_name>
      <phone>00 33 2 41 35 49 81</phone>
      <email>aupetit@chu-angers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>confinement</keyword>
  <keyword>chronic low back pain</keyword>
  <keyword>changes in pain intensity</keyword>
  <keyword>bio-psycho-social and occupational factors</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04406363
org study id: CONFI-LOMB
nct id: NCT04406363
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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:

        1. the association between the conditions of confinement and low back pain intensity;

        2. the association between the confinement conditions and disability related to low back
           pain;

        3. the association between infection with the new SARS-CoV-2 coronavirus and change in low
           back pain intensity;

        4. the association between the confinement conditions and the quality of life as well as
           the state of psychological health;

        5. the impact of confinement on the use of care and the consumption of medication and
           psychoactive substances for low back pain;

        6. the association between working conditions and / or teleworking and the low back pain
           intensity;

        7. 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.
observational model: Other
time perspective: Cross-Sectional
measure: Impact of confinement on the low back pain intensity
time frame: at inclusion
description: 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.
measure: Correlation between confinement conditions and low back pain intensity
time frame: at inclusion
description: 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.)
measure: Correlation between confinement conditions and disability related to low back pain
time frame: at inclusion
description: Disability measured by the "incapacity" sub-score of the "Core Outcome Measures Index" (COMI) questionnaire
measure: Correlation between infection with the new SARS-CoV-2 coronavirus and change in low back pain intensity
time frame: at inclusion
description: 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)
measure: Correlation between confinement conditions and quality of life as well as psychological health
time frame: at inclusion
description: 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);
measure: Impact of confinement on the use of care and the consumption of medication and psychoactive substances for low back pain
time frame: at inclusion
description: Use of care, drug consumption and psychoactive substances (tobacco, cannabis, alcohol, anxiolytics) for low back pain
measure: Correlation between working conditions and / or teleworking and low back pain intensity
time frame: at inclusion
description: Modalities of the the ocupational activity continuation (continuation of the activity, evolution of the working time, telework and modalities of establishment)
measure: Correlation between socio-economic factors and modalities as well as the experience of confinement
time frame: at inclusion
description: Experience of confinement. Socio-economic characteristics of the participants (age, sex, department, job and socio-professional category).
intervention type: Other
intervention name: non interventional
description: non interventional
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Pain
sharing ipd: No