CClinicalTrials.gg
TerminatedNCT04128098FRELOMBUpdated Oct 16, 2023

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

An observational study in Chronic Low-back Pain, sponsored by Centre Hospitalier Universitaire Dijon. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-16.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Why this study was terminated
The Covid pandemic made it impossible to monitor and rehabilitate patients at the Dijon Bourgogne CHU's CCR. A new home rehabilitation programme was set up. This new rehabilitation programme rendered the study obsolete and the project was abandoned.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Low-back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 2 is below the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2 participants (actual)
Patient registry
No

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

06

What researchers measure

Primary outcomes

  1. Proportion of good medium-term responders in a multimodal rehabilitation program

    Time frame: M13 (12 months after the end of the program)

07

Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04128098
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Oct 16, 2019
Start date
Jan 24, 2020
Primary completion
Feb 23, 2021
Completion
Feb 23, 2021
Last update
Oct 16, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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