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

Primary Purpose

Non Specific Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Education and rehabilitation associated with personalized follow-up
Reassuring messages and advices
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Specific Low Back Pain focused on measuring low back pain, activity limitations, disability, rehabilitation, physiotherapy, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Short multidisciplinary program including education and rehabilitation and a personalized follow-up program

Reassuring messages and advices in agreement with the current recommendations.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
days off work
Number of "days off work" reported by the patient
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)
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)
cost-utility ratio
Incremental cost-utility ratio

Full Information

First Posted
February 9, 2022
Last Updated
February 6, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05261828
Brief Title
Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP) (LOMBAFAST)
Acronym
LOMBAFAST
Official Title
Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Specific Low Back Pain
Keywords
low back pain, activity limitations, disability, rehabilitation, physiotherapy, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Short multidisciplinary program including education and rehabilitation and a personalized follow-up program
Arm Title
B
Arm Type
Active Comparator
Arm Description
Reassuring messages and advices in agreement with the current recommendations.
Intervention Type
Behavioral
Intervention Name(s)
Education and rehabilitation associated with personalized follow-up
Intervention Description
short multidisciplinary program including education and rehabilitation and a personalized follow-up for patients with subacute and chronic low back pain
Intervention Type
Behavioral
Intervention Name(s)
Reassuring messages and advices
Intervention Description
Reassuring messages and advices in agreement with current recommendations
Primary Outcome Measure Information:
Title
low back pain activity limitation
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
low back pain activity limitation
Description
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)
Time Frame
6 and 12 months.
Title
fears and beliefs about work
Description
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)
Time Frame
3 months
Title
fears and beliefs about physical activity
Description
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)
Time Frame
3 months
Title
days off work
Description
Number of "days off work" reported by the patient
Time Frame
3 and 12 months
Title
low back pain
Description
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)
Time Frame
3 months
Title
radicular pain
Description
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)
Time Frame
3 months
Title
cost-utility ratio
Description
Incremental cost-utility ratio
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle NGUYEN, MD, PhD
Phone
01 58 41 29 45
Email
christelle.nguyen2@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laetitia PEAUDECERF, PhD
Phone
01 58 41 12 13
Email
laetitia.peaudecerf@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra ROREN, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle NGUYEN, MD, PhD
Phone
01 58 41 29 45
Email
christelle.nguyen2@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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