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
| Type | Name | Description |
|---|---|---|
| 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. |
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.