Clinical trial NCT05261828: Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP)
Official title: Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non Specific Low Back Pain
Keywords: low back pain
activity limitations
disability
rehabilitation
physiotherapy
exercise
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are:

* to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability,
* to estimate the cost-utility ratio of the intervention.

Detailed description: Non-specific low back pain (LBP) is the leading cause of years lived with disability worldwide. Subacute LBP is commonly defined as back pain lasting between 6 weeks and 3 months, chronic LBP as pain that persists for 3 or more months. In its most severe forms, subacute and chronic LBP can lead to severe disability that combines physical and psychological deconditioning, limitations in basic and complex activities of daily living, professional exclusion and social marginalization.

The direct and indirect medical and economic cost of chronic LBP is major for society.

Since the eighties, the bio-psycho-social approach has emerged for the treatment of people with chronic LBP and has led to multidisciplinary functional restoration (FR) programs that include physical activity, exercises, education, occupational therapy and psychological and social rehabilitation. However, the efficiency of these programs is inconsistent and their cost-effectiveness is criticized.

As FR programs are by definition standardized, the treatment of chronic LBP remains poorly stratified. However, interest in stratified therapeutic strategies has recently emerged and shown promising results. To date, in France, only semi-intensive (\<100h) or intensive (\>100h) FR programs dedicated to severely disabled patients with chronic LBP have been assessed The investigators' main hypothesis is that an intervention consisting in a short multidisciplinary program including education and rehabilitation and a personalized follow-up could reduce the activity limitations of not severely disabled patients with subacute and chronic LBP.

The investigators' secondary hypothesis is that such an intervention could also reduce the main risk factors for evolution of patients with LBP towards a severe disability.

Eligibility criteria: Inclusion Criteria:

* Patients with subacute or chronic nonspecific low back pain (current episode duration ≥ 6 weeks), resistant to outpatient management, and including patients with radiculopathy as long as low back pain is predominant over pain in the lower extremity.
* Patients with less than 30 days off work (declarative) for low back pain in the previous year and involved in a professional activity at the time of inclusion.
* Patients manifesting fears and false beliefs and/or dramatization: to be included, the patient will have to answer yes to one of the following two questions:

  * Are you afraid to move?
  * Are you afraid you will never get out of it?
* Patients eligible for a rehabilitation exercise program
* informed and written consent to participate

Exclusion Criteria

* Age \< 18 years,
* Insufficient French language proficiency.
* Patients having followed a multidisciplinary rehabilitation program for their low back pain in the 3 months preceding inclusion.
* Patients who have had lumbar spine surgery within the last 12 months.
* Pregnancy in progress.
* No affiliation with a health insurance program.

Primary outcomes:
measure: low back pain activity limitation
timeFrame: 3 months
Secondary outcomes:
measure: low back pain activity limitation
timeFrame: 6 and 12 months.
measure: fears and beliefs about work
timeFrame: 3 months
measure: fears and beliefs about physical activity
timeFrame: 3 months
measure: days off work
timeFrame: 3 and 12 months
measure: low back pain
timeFrame: 3 months
measure: radicular pain
timeFrame: 3 months
measure: cost-utility ratio
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: APHP
name: Alexandra ROREN, PhD
role: PRINCIPAL_INVESTIGATOR
References: