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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03803501
Acronym
PRAMH
Enrollment
193
Registered
2019-01-14
Start date
2014-04-01
Completion date
2019-01-01
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

OTHERcondensed 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.

Sponsors

Pitié-Salpêtrière Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Oswestry disability indexchange between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not availablegives a subjective percentage score of level of function (disability) on a 0 to 100 scale, 100 being the highest disability state

Secondary

MeasureTime frameDescription
Radicular painchange between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not availablevisual analogue scale (0-100)
quality of lifechange between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not availableEQ5D scale, converted into a global index score with 1 indicating no restriction of quality of life and -1 the worse quality of life possible
patient acceptable symptom statechange between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not availablewhere patients reported their satisfaction on state of symptoms by picking acceptable or non acceptable
lumbar painchange between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not availablevisual analogue scale (0-100)
relative absenteeismchange 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(rapport between the hours lost and the hours expected to work per month, 0-100, 100 indicates the higher amount of absenteeism)
psychological distresschange 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(Hospital Anxiety and Depression scale)
World Health Organisation Health and Work Performance Questionnaire for absolute presenteeismchange 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(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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026