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

NCT03803501 | Completed

• 1 other identifier: HSalpetrierePRAMH
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry disability index

  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 Outcomes (7)

• lumbar pain

  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

  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

  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

  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

  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

Interventions

condensed functional restoration program OTHER

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.

Also known as: multidisciplinary rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• specific LBP and organic contraindication to physical exercise.

Sponsors & Collaborators

• Pitié-Salpêtrière Hospital: lead

Study Sites (1)

Davergne Thomas

Paris, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Master of Science and PhD candidate, principal investigator

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 14, 2019
• Study Start: April 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: January 1, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)