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

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: condensed functional restoration program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lumbar pain | 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 | 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 | 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 | 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 | (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 | (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 | (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 |