Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP) (LOMBAFAST)

Non Specific Low Back Pain Clinical Trial

— LOMBAFAST  

Official title:

Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05261828
• Other study ID #: APHP200142
• Secondary ID: 2020-A02601-38
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: February 2026

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Christelle NGUYEN, MD, PhD
• Phone: 01 58 41 29 45
• Email: christelle.nguyen2[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non Specific Low Back Pain

Intervention

Behavioral:
• Education and rehabilitation associated with personalized follow-up
short multidisciplinary program including education and rehabilitation and a personalized follow-up for patients with subacute and chronic low back pain
• Reassuring messages and advices
Reassuring messages and advices in agreement with current recommendations

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	low back pain activity limitation	Variation in the level of low back pain- activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation)	3 months
Secondary	low back pain activity limitation	Variation in the level of low back pain activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation)	6 and 12 months.
Secondary	fears and beliefs about work	Variation in the level of fears and beliefs about work assessed by the work sub score of the self-administered Fear-Avoidance Beliefs Questionnaire (FABQ) (0, no fears and beliefs and 24, maximum fears and beliefs)	3 months
Secondary	fears and beliefs about physical activity	Variation in the level of fears and beliefs about physical activity assessed by the physical activity sub score of the self-administered Fear-Avoidance Beliefs Questionnaire (FABQ) (FABQ), (0, no fears and beliefs and 42, maximum fears and beliefs)	3 months
Secondary	days off work	Number of "days off work" reported by the patient	3 and 12 months
Secondary	low back pain	Variation in the mean intensity of low back pain over the last 48 hours assessed on a self-administered numerical scale (0, no pain and 100,maximum pain)	3 months
Secondary	radicular pain	Change in mean intensity of radicular pain over the last 48 hours assessed on a self-administered numerical scale (0, no pain and 100,maximum pain)	3 months
Secondary	cost-utility ratio	Incremental cost-utility ratio	12 months