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

January 13, 2019 updated by: Thomas Davergne, Pitié-Salpêtrière Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Davergne Thomas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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
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
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"
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
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)
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
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)
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
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pitié-Salpêtrière Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 13, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSalpetrierePRAMH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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