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

Chronic Low-back Pain Clinical Trial

— FRELOMB  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04128098
• Other study ID #: ORNETTI PCA 2018-2
• Status: Terminated
• Start date: January 24, 2020
• Est. completion date: February 23, 2021

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Evaluation
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
• Questionnaires
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.
• Rehabilitation 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

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of good medium-term responders in a multimodal rehabilitation program		M13 (12 months after the end of the program)