Predictive Factors for the Success of Rehabilitation Programs in Chronic Low Back Pain

NCT07051772 | Recruiting

• 1 other identifier: NIMAO/2023-1/AD-01
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 6

Brief Summary

Chronic low back pain is the leading cause of years lived with disability in the world among 19-49 year olds. The usual progression leads to 15% of acute episodes of persistent pain and more than 50% of persistent activity limitations. Persistent pain lasting between 5 and 7 years causes relatively stable patterns, probably linked to well-known predictive factors of activity limitations such as psychosocial factors (catastrophizing, fears and maladaptive beliefs), physical (deconditioning), professional (fear of returning to work, stress, burden) or personal (financial, insecurity). The effectiveness of treatments is often difficult to predict. Current evidence does not support the use of pharmacological treatments given their low effectiveness and the risks associated with the prescription of non-steroidal anti-inflammatories or opioids, particularly in the chronic phase where the risk of dependence is highest. Thus, international recommendations strongly suggest the use of non-pharmacological therapies, including, physical exercises, rehabilitation, physical and sports activities and spinal manipulations. Most meta-analyses conclude that there is a cumulative effect of the different strategies, without the specific effect of each one being able to be isolated, justifying multidisciplinary protocols. A cornerstone of the management of chronic disabling low back pain therefore relies programs combining physical, cognitive-behavioral, psychological and professional care, most often in dedicated centers. The objective is to empower the patient and promote a change in behavior with regard to the consequences of their pain in the long-term. However, there are very few predictive criteria for the success or failure of these programs, probably because many multiple biological, psychological, and social factors interact over time. Certain models resulting from expert consensus seek to conceptualize these interactions and propose a categorization of these different factors. It is now crucial to validate these categorizations and their relative weight in the progression of patients to best guide their recovery. The aim of this work is to identify the biomarkers predictive of the success of multidisciplinary programs in the short-, medium- and long-term.

Conditions

Low Back Pain

Keywords

Biomarkers

Outcome Measures

Primary Outcomes (39)

• Level of disability

  Oswestry Disability Index questionnaire. Scoring: 0% to 20%: minimal disability, 20% to 40%: moderate disability, 40% to 60%: severe disability, 60% to 80%: major disability, and 80% to 100 %: bedridden or exaggerated.

  Baseline

• Level of disability

  Oswestry Disability Index questionnaire. Scoring: 0% to 20%: minimal disability, 20% to 40%: moderate disability, 40% to 60%: severe disability, 60% to 80%: major disability, and 80% to 100 %: bedridden or exaggerated.

  Month 6

• Patient age

  Years

  Baseline

• Patient sex

  Male/female

  Baseline

• Patient Body Mass Index

  Kg/m2

  Baseline

• Comorbidities

  List of medical pathologies and history of other pathologies of the musculoskeletal system (peripheral osteoarthritis, trauma to the musculoskeletal system, other musculoskeletal disorders).

  Baseline

• Pain duration

  Months

  Baseline

• Professional situation

  Description of profession

  Baseline

• Work stoppage

  Yes/No

  Baseline

• Work accident

  Yes/No

  Baseline

• Disability

  Yes/No

  Baseline

• Professional Life Satisfaction Scale Socio-economic level

  Baseline

• Marital status

  Baseline

• Number of children

  Number

  Baseline

• Kinesiophobia

  Tampa scale

  Baseline

• Coping strategies

  Coping Strategies Questionnaire

  Baseline

• Avoidance Beliefs

  Fear-Avoidance Beliefs Questionnaire

  Baseline

• Self-efficacy

  Pain Self-Efficacy Questionnaire

  Baseline

• Catastrophism

  Pain Catastrophizing Scale

  Baseline

• Acceptance

  Acceptance and Action Questionnaire

  Baseline

• Anxiety and depression

  Hospital Anxiety and Depression Scale

  Baseline

• Mobility

  Schöber test Finger-to-ground distance

  Baseline

• Static endurance of the abdominal muscles

  Shirado test, seconds

  Baseline

• Isometric endurance of hip and back extensor muscles

  Sorensen test, seconds

  Baseline

• Central Sensitization

  Central Sensitization Inventory

  Baseline

• Location of pain

  Patient-described using a body diagram

  Baseline

• Number and severity of discopathies

  Pfirmann classification, measured on MRI

  Baseline

• Modic changes on MRI

  Present/Absent

  Baseline

• Narrow lumbar canal

  Yes/No, Measured on MRI

  Baseline

• Postural disorder

  Yes/No

  Baseline

• Scoliosis

  Cobb angle

  Baseline

• Sagittal balance

  Measured using weight-bearing x-rays

  Baseline

• Physical Activity

  International Physical Activity Questionnaire

  Baseline

• Exercise Adherence Rating Scale Sleep

  Pittsburgh Questionnaire

  Baseline

• Smoking

  Baseline

• Alcohol consumption

  Baseline

• Drug use

  Yes/No

  Baseline

• Knowledge about low back pain

  Back Beliefs Questionnaire

  Baseline

• Treatment pathway

  Description of previous physiotherapy treatments, infiltrations, osteopathy/manual therapy, medicinal treatments

  Baseline

Secondary Outcomes (45)

• Level of disability

  Month 1

• Level of disability

  Month 3

• Level of disability

  Month 12

• Level of pain

  Month 1

• Level of pain

  Month 3

Study Arms (1)

Patients recruited from Nîmes center

Other: mobility skills testing session

Interventions

mobility skills testing session OTHER

A mobility skills testing session using the Qualisys system (Trinoma), when carrying out specific tasks plus 7-day recording of activity using an accelerometer.

Patients recruited from Nîmes center

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients from the active consultation line in the Physical Medicine and Rehabilitation departments of the University Hospitals of Nîmes, Montpellier and Clermont-Ferrand for chronic low back pain.

You may qualify if:

• Patient with chronic low back pain ≥ three months
• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan

You may not qualify if:

• The patient is participating in a category 1 interventional study, or a study on a medication or medical device without prior approval of the primary investigator
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• Patient followed or treated for a psychiatric, cancerous or orthopedic pathology that risks modifying their course of care
• Pregnant, parturient or breastfeeding patient.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

CHU de Clermont Ferrand

Clermont-Ferrand, Auvergne, 63000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30900, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, Occitanie, 34000, France

NOT YET RECRUITING

CHU de Nîmes

Nîmes, Occitanie, 30029, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, France

NOT YET RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Dupeyron

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnaud Dupeyron

CONTACT

04.66.68.34.59; arnaud.dupeyron@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: July 4, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

FR (6)