Clinical trial NCT03803501: Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients
Official title: Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Pitié-Salpêtrière Hospital
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: Oswestry disability index
timeFrame: 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 outcomes:
measure: lumbar pain
timeFrame: 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
measure: Radicular pain
timeFrame: 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
measure: quality of life
timeFrame: 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
measure: patient acceptable symptom state
timeFrame: 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
measure: World Health Organisation Health and Work Performance Questionnaire for absolute presenteeism
timeFrame: 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
measure: relative absenteeism
timeFrame: 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
measure: psychological distress
timeFrame: 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
Other outcomes:
Locations:
city: Paris
country: France
facility: Davergne Thomas
Study officials:
References: