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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04128098
Acronym
FRELOMB
Enrollment
2
Registered
2019-10-16
Start date
2020-01-24
Completion date
2021-02-23
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain

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.

Interventions

OTHEREvaluation

* Functional tests: 400-meter walking test, 200-meter brisk walking test, Sorensen test, Shirado test, measurement of maximum isometric force of extensors/back flexors. * 3D analysis of locomotion and posture * Test of the flexion-relaxation phenomenon of the lumbar erector muscles

OTHERQuestionnaires

Self-questionnaires: Oswestry, Québec, SF-12, VAS pain, HAD, pain dramatization questionnaire, physical activity questionnaires, VAS and GPE satisfaction, FABQ, GPE functional status and EPICES score.

OTHERRehabilitation care program

* Personalized global exercises (aerobics) on ergometers * Muscle strengthening with resistance * Balneotherapy * Learning health skills related to their condition (therapeutic education) * Personal and group motivational interviews * Nutritional advice * Relaxation session

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of good medium-term responders in a multimodal rehabilitation programM13 (12 months after the end of the program)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026