<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/NCT03803501</url>
  </required_header>
  <id_info>
    <org_study_id>HSalpetrierePRAMH</org_study_id>
    <nct_id>NCT03803501</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients</brief_title>
  <acronym>PRAMH</acronym>
  <official_title>Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pitié-Salpêtrière Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pitié-Salpêtrière Hospital</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 aim was to assess the effectiveness of a condensed functional restoration program (CFRP)&#xD;
      for patients with chronic low back pain and professional activity.&#xD;
&#xD;
      Methods: Longitudinal 1 to 3 months study of patients with non-specific chronic low back pain&#xD;
      in one tertiary care hospital, participating in a CFRP (complex interprofessional&#xD;
      intervention over 4 days). The primary outcome was the Oswestry Disability Index (ODI) (0-100&#xD;
      scale). Secondary outcomes included pain, quality of life (EQ5D), patient acceptable symptom&#xD;
      state, presenteeism, absenteeism and psychological distress (Hospital Anxiety and Depression&#xD;
      scale). Outcomes were compared using paired sample Student's t-test or Chi2 between baseline&#xD;
      and last follow-up. Logistic regression was used to identify factors associated with better&#xD;
      response (improvement of ODI higher than 12.8) and included baseline demographic,&#xD;
      psychological and physical assessment variables.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry disability index</measure>
    <time_frame>change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available</time_frame>
    <description>gives a subjective percentage score of level of function (disability) on a 0 to 100 scale, 100 being the highest disability state</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>lumbar pain</measure>
    <time_frame>change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available</time_frame>
    <description>visual analogue scale (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radicular pain</measure>
    <time_frame>change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available</time_frame>
    <description>visual analogue scale (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available</time_frame>
    <description>EQ5D scale, converted into a global index score with 1 indicating no restriction of quality of life and -1 the worse quality of life possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient acceptable symptom state</measure>
    <time_frame>change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available</time_frame>
    <description>where patients reported their satisfaction on state of symptoms by picking &quot;acceptable&quot; or &quot;non acceptable&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organisation Health and Work Performance Questionnaire for absolute presenteeism</measure>
    <time_frame>change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available</time_frame>
    <description>(reflecting the patient's overall job performance on the days worked during the past 4 weeks, 0-100, 100 being the highest amount of performance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>relative absenteeism</measure>
    <time_frame>change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available</time_frame>
    <description>(rapport between the hours lost and the hours expected to work per month, 0-100, 100 indicates the higher amount of absenteeism)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>psychological distress</measure>
    <time_frame>change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available</time_frame>
    <description>(Hospital Anxiety and Depression scale)</description>
  </secondary_outcome>
  <enrollment type="Actual">193</enrollment>
  <condition>Low Back Pain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>condensed functional restoration program</intervention_name>
    <description>The condensed functional restoration program (CFRP) is a complex multidisciplinary intervention proposed as usual care according to international guidelines. The program takes place in our department of rheumatology, 6 hours per day, 1 day a week, for 4 weeks. Patients are included during consultation or Hospitalisation and are in groups of 6 maximum per FRP. The CRFP was developed on the basis of therapeutic patient education programs and physical exercises (Van Wambeke 2017, Desthieux 2014). Three hours per day are devoted to physical exercises which were divided into three periods: warming, stretching, and muscular strengthening. Specific exercises adapted to work circumstances (like manutention) are taught. Muscular strengthening is based on isotonic contraction on fitness devices. Education is based on 1 hour long educative session adapted from back school programs once a week. Educative booklets are also given to the patients.</description>
    <other_name>multidisciplinary rehabilitation program</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic low back pain who participated in the condensed functional&#xD;
        restoration program between April 2012 and April 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-specific cLBP (&gt;3 months) with or without radicular pain, not currently in&#xD;
             prolonged sick leave, no current indication for surgery, fluent in French,&#xD;
             difficulties to maintain daily physical activity due to LBP with Oswestry Disability&#xD;
             Index and lumbar and radicular pain at baseline and at end of intervention or 3-month&#xD;
             follow-up available.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  specific LBP and organic contraindication to physical exercise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Davergne Thomas</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pitié-Salpêtrière Hospital</investigator_affiliation>
    <investigator_full_name>Thomas Davergne</investigator_full_name>
    <investigator_title>Physiotherapist, Master of Science and PhD candidate, principal investigator</investigator_title>
  </responsible_party>
  <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>
  </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/NCT03803501
org study id: HSalpetrierePRAMH
nct id: NCT03803501
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim was to assess the effectiveness of a condensed functional restoration program (CFRP)
      for patients with chronic low back pain and professional activity.

      Methods: Longitudinal 1 to 3 months study of patients with non-specific chronic low back pain
      in one tertiary care hospital, participating in a CFRP (complex interprofessional
      intervention over 4 days). The primary outcome was the Oswestry Disability Index (ODI) (0-100
      scale). Secondary outcomes included pain, quality of life (EQ5D), patient acceptable symptom
      state, presenteeism, absenteeism and psychological distress (Hospital Anxiety and Depression
      scale). Outcomes were compared using paired sample Student's t-test or Chi2 between baseline
      and last follow-up. Logistic regression was used to identify factors associated with better
      response (improvement of ODI higher than 12.8) and included baseline demographic,
      psychological and physical assessment variables.
observational model: Cohort
time perspective: Prospective
measure: Oswestry disability index
time frame: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
description: gives a subjective percentage score of level of function (disability) on a 0 to 100 scale, 100 being the highest disability state
measure: lumbar pain
time frame: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
description: visual analogue scale (0-100)
measure: Radicular pain
time frame: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
description: visual analogue scale (0-100)
measure: quality of life
time frame: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
description: EQ5D scale, converted into a global index score with 1 indicating no restriction of quality of life and -1 the worse quality of life possible
measure: patient acceptable symptom state
time frame: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
description: where patients reported their satisfaction on state of symptoms by picking "acceptable" or "non acceptable"
measure: World Health Organisation Health and Work Performance Questionnaire for absolute presenteeism
time frame: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
description: (reflecting the patient's overall job performance on the days worked during the past 4 weeks, 0-100, 100 being the highest amount of performance)
measure: relative absenteeism
time frame: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
description: (rapport between the hours lost and the hours expected to work per month, 0-100, 100 indicates the higher amount of absenteeism)
measure: psychological distress
time frame: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
description: (Hospital Anxiety and Depression scale)
intervention type: Other
intervention name: condensed functional restoration program
description: The condensed functional restoration program (CFRP) is a complex multidisciplinary intervention proposed as usual care according to international guidelines. The program takes place in our department of rheumatology, 6 hours per day, 1 day a week, for 4 weeks. Patients are included during consultation or Hospitalisation and are in groups of 6 maximum per FRP. The CRFP was developed on the basis of therapeutic patient education programs and physical exercises (Van Wambeke 2017, Desthieux 2014). Three hours per day are devoted to physical exercises which were divided into three periods: warming, stretching, and muscular strengthening. Specific exercises adapted to work circumstances (like manutention) are taught. Muscular strengthening is based on isotonic contraction on fitness devices. Education is based on 1 hour long educative session adapted from back school programs once a week. Educative booklets are also given to the patients.
other name: multidisciplinary rehabilitation program
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Pitié-Salpêtrière Hospital
investigator full name: Thomas Davergne
investigator title: Physiotherapist, Master of Science and PhD candidate, principal investigator
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No