Functional Restoration for Chronic Low Back Pain: Medico-economic Impact

Condition(s) studied

Investigational drug(s) / intervention(s)

functional restoration: The functional restoration program will be carried out in investigation centers, in day hospitals, five days a week for four to five weeks, for a total of 110 hours ± 10. It will involve physicians specializing in physical medicine and rehabilitation or rheumatologists, and various medical rehabilitation assistants for physical therapy, occupational therapy, therapeutic education, and social assistance. Occupational physician and, where applicable, medical advisor, for each patient will also be involved. The program is organized into modules provided in group or individual sessions. Patients will receive daily medical follow-up, which will contribute to psychological support, allow for the adjustment of pain medication, and, if necessary, the adaptation of the program. Patients will be referred, as needed, to a psychologist or psychiatrist for joint care. A predetermined step-by-step progression will be proposed and established based on initial abilities for physical interventions.

non-intensive rehabilitation: Treatment for the comparator group will involve: a doctor specializing in physical medicine and rehabilitation or rheumatology (two consultations), physical therapists (12 half-hour sessions), social workers (one visit), occupational physicians (one consultation), and, as needed, psychiatrists and psychologists. Patients will also attend two educational sessions. The educational sessions will take place at the investigation centers. They will be conducted by non-medical staff. The topics covered will include inappropriate fears and beliefs, physical activity, neurophysiology and pain management, and coping strategies. The physical therapy sessions will be conducted in outpatient setting. The prescription for physical therapy will specify 12 sessions over 5 weeks, devoted to supervised practice of mobilization, stretching, and muscle strengthening techniques, as well as learning self-rehabilitation.

Study summary

The hypothesis is that functional restoration is not only effective in term of activity limitation, but also efficient, in regard to its impact on this criterion, the use of healthcare services, return to work and job retention, in the context of chronic low back pain with occupational disability.

The main objective is the medico-economic evaluation of a functional restoration program for chronic low back pain, in order to determine its efficiency using a differential cost-utility approach from an insurance perspective at 24 months after inclusion.

Eligibility

Primary outcome measure(s)

• Incremental cost per quality-adjusted life year (QALY) — At 24 months after randomization
  Incremental cost per quality-adjusted life year (QALY) at 24 months after inclusion, established using the EuroQol 5 Dimensions (EQ-5D) questionnaire and resource utilization costs. Resource utilization costs correspond to healthcare costs and compensation for occupational disability.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France