Clinical trial NCT04128098: Frequency of Correct Response and Factors Associated in the Medium Term With a Multimodal Rehabilitation Program for Chronic Low Back Pain
Official title: Frequency of Correct Response and Factors Associated in the Medium Term With a Multimodal Rehabilitation Program for Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Low-back Pain
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient presenting for consultation in the re-education and rehabilitation department of the CHU Dijon Bourgogne

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of good medium-term responders in a multimodal rehabilitation program
timeFrame: M13 (12 months after the end of the program)
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: