Clinical Trials Directory

Trials / Completed

CompletedNCT03803501

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

Status
Completed
Phase
Study type
Observational
Enrollment
193 (actual)
Sponsor
Pitié-Salpêtrière Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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

Interventions

TypeNameDescription
OTHERcondensed functional restoration programThe 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.

Timeline

Start date
2014-04-01
Primary completion
2018-04-01
Completion
2019-01-01
First posted
2019-01-14
Last updated
2019-01-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03803501. Inclusion in this directory is not an endorsement.