NCT07472374

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

Medico-economic Impact of Functional Restoration for Chronic Low Back Pain: a Multicenter, Prospective, Controlled, Randomized Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Scientific justification Low back pain is a major public health problem. It is the leading cause of functional limitation in adults and one of the primary areas of expenditure for national health systems. Indirect costs account for the majority of related expenses. Chronic low back pain accounts for 80% of compensation for occupational disability due to low back pain. It generates most of the costs attributable to all common low back pain. Mainland and Caribbean France are no exception to this reality. A national study conducted by the French health insurance system in 2014 shows that low back pain accounts for 30% of work stoppages lasting more than six months and 20% of all workplace accidents. A survey conducted under the auspices of the Martinique Regional Health Agency in five hospitals indicates that 75% of healthcare workers had experienced an episode of low back pain in the previous three years, and that half had taken time off work for this reason. The prevalence of chronic low back pain in this population of workers was 25%. Therapeutic recommendations converge on the benefits of coordinated multidisciplinary physical medicine and rehabilitation programs for chronic low back pain. Functional restoration is a coordinated multidisciplinary approach to the management of chronic low back pain. Its effect on functional limitation in chronic low back pain has now been demonstrated, but the efficiency of this treatment remains to be characterized. Thus, the efficiency of functional restoration for chronic low back pain has not yet been evaluated. Functional restoration reduces functional limitation in the short term and at one year. In France, a randomized trial indicates the possibility of a reduction in occupational disability. Investigators experience based on a prospective analysis also supports this. The efficiency of functional restoration for chronic low back pain has not been evaluated. The management of chronic low back pain in the French West Indies has been little studied. Demonstrating the efficiency of functional restoration through a cost-utility approach now appears to be a necessary next step in the continued development of this type of care. It could contribute to the spread of a treatment modality that is useful for patients, economically viable, and even profitable due to its effect on the overall costs generated by the disease. The hypothesis is that functional restoration is not only effective in terms of functional limitation, but also efficient in terms of its impact on this criterion, on the use of healthcare, return to work, and job retention in cases of chronic low back pain with occupational disability. Primary objective. Medical-economic evaluation of a functional restoration program for chronic low back pain to determine its efficiency using a differential cost-utility approach from an insurance perspective at 24 months after inclusion. Secondary objectives. 1. Medical-economic evaluation of a functional restoration program for chronic low back pain to determine its efficiency using a cost-utility approach from an insurance, healthcare system, and individual perspective at 12 and 24 months; through a 5-year budget impact analysis; 2. Evaluation of the impact of a functional restoration program on overall pain, lumbar or radiating pain, functional limitation, anxiety and depression, maladaptive fears and beliefs, coping strategies, physical activity, and adherence to self-rehabilitation at 4 months, 12 months, and 24 months; on quality of life, resource use, return to work, absenteeism, and presenteeism every 4 months. Experimental design Interventional, multicenter, prospective, comparative, randomized, two-arm, controlled study, using the PROBE (Prospective Randomized Open Blinded End-point) methodology, with blinded assessment. The report will follow the CONSORT recommendations for non-pharmacological trials. Target population Adult patients of working age, residing in mainland or Caribbean France, suffering from chronic low back pain resulting in sick leave. Acts or Products subject to investigation The functional restoration program is the treatment being investigated. It 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 begin with a multidisciplinary assessment. This program will involve physicians specializing in physical medicine and rehabilitation or rheumatologists, as well as 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: education; aerobic activities; gymnastics; muscle strengthening; handling; and socio-professional reinsertion. Some will be carried out in groups: gymnastics, aerobic activities, muscle strengthening, and handling. Education will be provided in individual and/or group sessions, in the form of scenario-based exercises and/or therapeutic education. The scenario-based exercises will aim to improve comfort in carrying out daily activities. It will include time to express difficulties and needs, followed by practical sessions in simulation or real-life situations. Therapeutic education will aim to reduce the impact of low back pain on patients' daily lives. It will include a period of identifying difficulties and needs, followed by group sessions in the form of roundtable discussions. The social and professional reinsertion module will take the form of individual interviews. 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. Depending on the modules, it will take into account the intensity, volume, and duration of physical effort. With their consent, patients will be referred to their occupational physician for a pre-return consultation during the program. A meeting with the medical advisor will be considered on a case-by-case basis depending on the need to adapt social protection measures. Comparator group 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. Other acts or proceedings added by the search Inclusion visits and assessment visits at 4 months, 12 months, and 24 months after inclusion. Remote assessment at 8 months, 16 months, and 20 months. Expected benefits for participants and society The expected benefits for participants are active treatment for chronic low back pain and care provided by specialized teams. Functional restoration is expected to be an effective therapeutic option for chronic low back pain that causes disability and prevents people from working. Its impact on limiting activity and work disability could help reduce the overall costs associated with the condition. The results obtained could thus establish the clinical and economic benefits of functional restoration. They could enable the dissemination of a therapeutic modality that is both useful for patients and economically valuable from a collective perspective, in the context of a major public health problem. Minimal risks and constraints added by the research Participation in the research does not pose any foreseeable or known risks to patients. The minimal constraints associated with the research relate to participation in routine assessment visits before treatment, at 4 months, 12 months, and 24 months, as well as remote assessments (by mail, email, or telephone) at 8 months, 16 months, and 20 months. Practical details Patients seen during the inclusion visit will be given information about the study. They will also undergo a clinical examination and assessment. Their standard X-ray or MRI of the lumbar spine, performed beforehand as part of routine practice, will be examined. If no such examination has been performed, it will be prescribed, carried out locally, then retrieved and examined by the investigator responsible for inclusion. After informing the patient and obtaining their written consent, verifying the inclusion criteria, and ensuring that there are no exclusion criteria, the patient will be included in the study. Randomization will take place after inclusion, immediately following the inclusion visit. The randomly assigned treatments will be started within 5 weeks of inclusion and randomization. Patients included in the study will be seen for evaluation visits at 4 months, 12 months, and 24 months after inclusion. The evaluation visits will not include additional tests or functional explorations. They will also have a remote evaluation (by mail, email, or telephone) at 8 months, 16 months, and 20 months. Number of selected subjects \- 242 subjects selected in mainland and caribbean France Research schedule * Inclusion period: 24 months * Participation period (treatment + follow-up): 24 months * Total duration: 48 months +/- 2 months * Duration of prohibition from participating in other research and justification: duration of participation in this study, i.e., 24 months, for interventional research and research involving minimal risks and constraints, so as not to influence the results of the current study; no prohibition for non-interventional research. Mean number of planned inclusions per center per month 1.12 inclusion per center and per month Medico-economic analysis The economic evaluation will be conducted in accordance with the (updated) recommendations of the HAS (French National Authority for Health) and the CHEERS collaboration, measuring the costs and outcomes at 24 months after inclusion in the same population. The proposed analysis will be a cost-utility analysis, which is justified by the importance of quality of life in this disease, which has no impact on mortality. Investigators have selected three perspectives for the economic evaluation: the perspective of the French national health insurance system as the main analysis, the perspective of the healthcare system, and the individual perspective as a secondary analysis Statistical analysis The descriptive statistical analysis will include for each quantitative parameter: mean, standard deviation, associated 95% two-sided confidence intervals, minimum, maximum, median and quartiles, number of missing values. Qualitative parameters will be expressed by distribution frequency and associated 95% two-sided confidence intervals. In addition, the differences between the two groups and their associated 95% two-sided confidence intervals will be calculated at different times during the study. Depending on the type of variable, differences in mean, median, or percentage will be considered. Similarly, depending on the statistical distribution of the variables considered, asymptotic, exact, or bootstrap confidence intervals will be used.

Conditions

• Nonspecific Chronic Low Back Pain With Work Disability

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-03-10
• Primary completion: 2028-07-31
• Completion: 2030-05-31
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: France