Frequency of Correct Response and Factors Associated in the Medium Term With a Multimodal Rehabilitation Program for Chronic Low Back Pain (FRELOMB)

Non-specific chronic low back pain is defined as pain that originates in the lumbar spine, is persistent, lasts more than 3 months, and is unrelated to an inflammatory, traumatic, tumour, malformation, or infectious cause. Chronic low back pain is one of the most frequent reasons for consulting a physician, and one of the most common sources of disability, particularly as a result of socio-professional withdrawl. It is a major consumer of health resources (diagnostic investigations, multiple treatments) and involves heavy expenses for the investigator's health insurance system. In view of this major public health issue, in November 2017, the Health Insurance and several specialized health organizations launched a "general public" campaign to raise awareness of low back pain. This campaign, entitled "Back pain? The right treatment is movement" was designed to encourage appropriate physical activity in patients with low back pain.

Among the available therapies, multimodal programs are recommended as a first line treatment. In order to incorporate physical activity into patients' daily lives, these rehabilitation programs are based on a comprehensive multidisciplinary approach (therapeutic education, muscle strengthening, reconditioning, ergonomics, psychological, social, professional and nutritional management and cardiovascular risk factors). Although such programmes have already shown short term effectiveness, few data are available on their continued effectiveness in the medium term (1 year). This project aims to identify good and bad responders to a multimodal program in the medium term, based on common clinical parameters (Quebec City questionnaire score and spontaneous walking speed), and to identify the mechanisms underlying this response.

In addition, in clinical practice, heterogeneity in maintaining the effectiveness of the program is observed but little documented. The limited data available show a heterogeneity of these programs and one of the objectives of this project will be to identify the existing barriers and levers available to improve this situation.

Study Overview

• Status: Terminated
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Evaluation; Other: Questionnaires; Other: Rehabilitation care program

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

• Study Contact: Name: Paul ORNETTI; Phone Number: +33 03.80.29.35.71; Email: paul.ornetti@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21079
    • CHU dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patient presenting for consultation in the re-education and rehabilitation department of the CHU Dijon Bourgogne

Description

Inclusion Criteria:

• Adult patient
• Having provided oral consent
• Chronic non-specific low back pain (HAS2015 criteria)
• Eligible for a rehabilitation program
• Patient affiliated or benefiting from a social security scheme

Exclusion Criteria:

• Adult unable to provide consent
• Lumbar spine surgery scheduled in the coming year
• Associated pathologies other than spinal (orthopedic, neurological, vascular, cardiac...) that can affect locomotion
• Root damage with motor deficit <3
• Altered comprehension skills making self-assessment impossible
• Patient subject to a protective measure (guardianship, curatorship)
• Patient subject to a judicial protection
• Pregnant, parturient or breastfeeding woman
• Not fluent in French
• Patient who has already completed a multimodal rehabilitation program

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of good medium-term responders in a multimodal rehabilitation program	M13 (12 months after the end of the program)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): February 23, 2021
• Study Completion (Actual): February 23, 2021

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ORNETTI PCA 2018-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No