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Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients (PRAMH)

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ClinicalTrials.gov Identifier: NCT03803501
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Davergne, Pitié-Salpêtrière Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Low Back Pain Other: condensed functional restoration program

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Study Type : Observational
Actual Enrollment : 193 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain


Intervention Details:
  • Other: condensed functional restoration program
    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


Primary Outcome Measures :
  1. 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 ]
    gives a subjective percentage score of level of function (disability) on a 0 to 100 scale, 100 being the highest disability state


Secondary Outcome Measures :
  1. 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 ]
    visual analogue scale (0-100)

  2. 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 ]
    visual analogue scale (0-100)

  3. 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 ]
    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

  4. 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 ]
    where patients reported their satisfaction on state of symptoms by picking "acceptable" or "non acceptable"

  5. 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 ]
    (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)

  6. 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 ]
    (rapport between the hours lost and the hours expected to work per month, 0-100, 100 indicates the higher amount of absenteeism)

  7. 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 ]
    (Hospital Anxiety and Depression scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic low back pain who participated in the condensed functional restoration program between April 2012 and April 2018
Criteria

Inclusion Criteria:

  • non-specific cLBP (>3 months) with or without radicular pain, not currently in prolonged sick leave, no current indication for surgery, fluent in French, difficulties to maintain daily physical activity due to LBP with Oswestry Disability Index and lumbar and radicular pain at baseline and at end of intervention or 3-month follow-up available.

Exclusion Criteria:

  • specific LBP and organic contraindication to physical exercise.

Information from the National Library of Medicine

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): NCT03803501


Locations
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France
Davergne Thomas
Paris, France
Sponsors and Collaborators
Pitié-Salpêtrière Hospital
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Responsible Party: Thomas Davergne, Physiotherapist, Master of Science and PhD candidate, principal investigator, Pitié-Salpêtrière Hospital
ClinicalTrials.gov Identifier: NCT03803501    
Other Study ID Numbers: HSalpetrierePRAMH
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations