Clinical trial NCT03936725: Evaluation of Return to Work One Year After a Rehabilitation Program for Chronic Back Pain
Official title: Evaluation of Return to Work One Year After a Short Rehabilitation Program for Chronic Non Specific Low Back Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Specific Chronic Low Back Pain
Keywords: Rehabilitation program
Non specific chronic low back pain
Return to work
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who participated in the functional spine rehabilitation program proposed by the department of Physical Medicine and Rehabilitation of the University Hospital of Lapeyronie in Montpellier

Brief summary: Return to work is one of the essential objectives of functional spinal restoration programs. When the duration of the work stoppage increases, the chances of returning to work become worse. No studies have yet evaluated the value of a short 2-week restoration program.

The purpose of this study is to determine whether a 2-week functional restoration program regains a return-to-work rate similar to longer-term restoration programs at one year post-program.

This retrospective study with prospective referral included 200 patients with non specific chronic low-back pain who participated in a self-care rehabilitation program between May 2018 and May 2019. The program included both physical and educational approaches to dealing with the condition. The duration was two weeks with follow-up at three months.

The main evaluation criterion was to evaluate the return to work rate by telephone at one year post-program. Secondary objectives were to observe return-to-work conditions, absenteeism, recovery time, pain and physical activity at one year post-program and also to observe if there was a possible association between intrinsic/extrinsic factors and return to work

Detailed description: Patients were included in the study from May 2019 to May 2020 if they had chronic nonspecific low back pain of more than 12 weeks according to the French health authority (High Authority of Health).

The data for this study were collected after validation by the ethics committee (Institutional Review Board). Initial data were collected from generation of a list of computerized medical records of low back pain patients who participated in the program between May 2018 and May 2019 and were hospitalized in the day or week area of follow-up and rehabilitative care : age, sex, BMI, marital status, clinical elements related to the low-back pain (total duration of low back pain, history of spine surgery, last spinal imaging, pain measured on a visual analog scale, analgesic consumption, tobacco consumption, physical activity, self-exercise, physiotherapy, Schober index, finger-ground distance, poplitates angles, heel-buttock distance) and professional situation (professional status, carrying heavy loads, sick leave accumulated prior hospitalization for back pain, professional status, occupational disease, occupational accident, disability, half-time therapy).

One-year post-program data were collected by telephone after consent was received. The investigators collected the date of return to work, elements concerning the conditions of return to work (modification of the previous position, working time, type of contract, work stoppages related to back pain, evolution of global job satisfaction before/after program ) and clinical elements (change in pain after the program, physical activity, self-stretching exercises, spine operation after the program,satisfaction of the rehabilitation program, benefit provided by the program).

Reference Methodology MR-004 was applied to the study after approval by the Data Protection Officer (CNIL). An information letter was sent to the selected patients to comply with the applicable regulations (RGPD). The patient was not included if he returned the non-consent form.

Program : The duration of hospitalization was 2 weeks and the care program was delivered, for each patient, by the same medical and paramedical team including doctors, physiotherapists, occupational therapists, a nurse. There was no change in the program during the 2018-2019 year, so the hospitalized patients received the same program. The functional restoration program included stretching and muscle strengthening of the spine and sub-pelvic planes, abdominal sheathing, gymnastics, exercise re-training sessions, self-exercise training, balneotherapy, relaxation sessions, sessions of body awareness and ergonomics.

Eligibility criteria: Inclusion criteria

* age between 18 and 65 years
* lumbalgia for more than 12 weeks labeled nonspecific (= common mechanics)
* have benefited fully from the 2-week day hospital rehabilitation program.

Exclusion criteria

* secondary low back pain
* immediate postoperative hospitalization (\<3 months)
* patient who died at the time of the study
* non-updated telephone numbers
* housewife, students subject subject to protection (curatorship, safeguard of justice, guardianship)
* Serious co-morbidities

Primary outcomes:
measure: Return to work at one year post-program
timeFrame: 1 year
Secondary outcomes:
measure: Absenteeism rate during the 12-month post-program
timeFrame: 1 year
measure: The delay of return to work post-program
timeFrame: 1 year
measure: Conditions of return to work
timeFrame: 1 year
measure: Pain at 1 year post-program
timeFrame: 1 year
measure: Physical activity at 1 year post-program
timeFrame: 1 year
measure: Evaluating intrinsic or extrinsic factors are associated with a professional recovery
timeFrame: 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: CHU de Montpellier
name: Marie HILLION, medical intern
role: PRINCIPAL_INVESTIGATOR
References: