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NCT Number: NCT07051772

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont Ferrand, Clermont-Ferrand, Auvergne, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • The patient is in a period of exclusion determined by a previous study
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Level of disability

    Time frame: Baseline

    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.

  2. Level of disability

    Time frame: Month 6

    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.

  3. Patient age

    Time frame: Baseline

    Years

  4. Patient sex

    Time frame: Baseline

    Male/female

  5. Patient Body Mass Index

    Time frame: Baseline

    Kg/m2

  6. Comorbidities

    Time frame: Baseline

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

  7. Pain duration

    Time frame: Baseline

    Months

  8. Professional situation

    Time frame: Baseline

    Description of profession

  9. Work stoppage

    Time frame: Baseline

    Yes/No

  10. Work accident

    Time frame: Baseline

    Yes/No

  11. Disability

    Time frame: Baseline

    Yes/No

  12. Professional Life Satisfaction Scale Socio-economic level

    Time frame: Baseline

  13. Marital status

    Time frame: Baseline

  14. Number of children

    Time frame: Baseline

    Number

  15. Kinesiophobia

    Time frame: Baseline

    Tampa scale

  16. Coping strategies

    Time frame: Baseline

    Coping Strategies Questionnaire

  17. Avoidance Beliefs

    Time frame: Baseline

    Fear-Avoidance Beliefs Questionnaire

  18. Self-efficacy

    Time frame: Baseline

    Pain Self-Efficacy Questionnaire

  19. Catastrophism

    Time frame: Baseline

    Pain Catastrophizing Scale

  20. Acceptance

    Time frame: Baseline

    Acceptance and Action Questionnaire

  21. Anxiety and depression

    Time frame: Baseline

    Hospital Anxiety and Depression Scale

  22. Mobility

    Time frame: Baseline

    Schöber test Finger-to-ground distance

  23. Static endurance of the abdominal muscles

    Time frame: Baseline

    Shirado test, seconds

  24. Isometric endurance of hip and back extensor muscles

    Time frame: Baseline

    Sorensen test, seconds

  25. Central Sensitization

    Time frame: Baseline

    Central Sensitization Inventory

  26. Location of pain

    Time frame: Baseline

    Patient-described using a body diagram

  27. Number and severity of discopathies

    Time frame: Baseline

    Pfirmann classification, measured on MRI

  28. Modic changes on MRI

    Time frame: Baseline

    Present/Absent

  29. Narrow lumbar canal

    Time frame: Baseline

    Yes/No, Measured on MRI

  30. Postural disorder

    Time frame: Baseline

    Yes/No

  31. Scoliosis

    Time frame: Baseline

    Cobb angle

  32. Sagittal balance

    Time frame: Baseline

    Measured using weight-bearing x-rays

  33. Physical Activity

    Time frame: Baseline

    International Physical Activity Questionnaire

  34. Exercise Adherence Rating Scale Sleep

    Time frame: Baseline

    Pittsburgh Questionnaire

  35. Smoking

    Time frame: Baseline

  36. Alcohol consumption

    Time frame: Baseline

  37. Drug use

    Time frame: Baseline

    Yes/No

  38. Knowledge about low back pain

    Time frame: Baseline

    Back Beliefs Questionnaire

  39. Treatment pathway

    Time frame: Baseline

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

Secondary outcomes

  1. Level of disability

    Time frame: Month 1

    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.

  2. Level of disability

    Time frame: Month 3

    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.

  3. Level of disability

    Time frame: Month 12

    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.

  4. Level of pain

    Time frame: Month 1

    Visual Analog Scale, 0-100

  5. Level of pain

    Time frame: Month 3

    Visual Analog Scale, 0-100

  6. Level of pain

    Time frame: Month 6

    Visual Analog Scale, 0-100

  7. Level of pain

    Time frame: Month 12

    Visual Analog Scale, 0-100

  8. Patient-reported health-related quality of life

    Time frame: Baseline

    Quality of life questionnaire EQ-5D questionnaire, score 0-100

  9. Patient-reported health-related quality of life

    Time frame: Month 1

    EQ-5D questionnaire, score 0-100

  10. Patient-reported health-related quality of life

    Time frame: Month 3

    Quality of life questionnaire EQ-5D questionnaire, score 0-100

  11. Patient-reported health-related quality of life

    Time frame: Month 6

    EQ-5D questionnaire, score 0-100

  12. Patient-reported health-related quality of life

    Time frame: Month 12

    EQ-5D questionnaire, score 0-100

  13. Return to work

    Time frame: Month 12

    Number of days until return to work after end of physiotherapy program

  14. Patients' feelings about symptoms

    Time frame: Month 1

    PGI-C (Patient Global Impression of Change) questionnaire, score 1-7

  15. Patients' feelings about symptoms

    Time frame: Month 3

    PGI-C (Patient Global Impression of Change) questionnaire, score 1-7

  16. Patients' feelings about symptoms

    Time frame: Month 6

    PGI-C (Patient Global Impression of Change) questionnaire, score 1-7

  17. Patients' feelings about symptoms

    Time frame: Month 12

    PGI-C (Patient Global Impression of Change) questionnaire, score 1-7

  18. Mobility abilities of willing patients recruited in the Nîmes center during walking

    Time frame: Baseline

    Three-dimensional optokinetic analysis using Qualisys system

  19. Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations

    Time frame: Baseline

    Three-dimensional optokinetic analysis using Qualisys system

  20. Mobility abilities of willing patients recruited in the Nîmes center during drop jumps

    Time frame: Baseline

    Three-dimensional optokinetic analysis using Qualisys system

  21. Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test

    Time frame: Baseline

    Three-dimensional optokinetic analysis using Qualisys system

  22. Mobility abilities of willing patients recruited in the Nîmes center during walking

    Time frame: Month 3

    Three-dimensional optokinetic analysis using Qualisys system

  23. Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations

    Time frame: Month 3

    Three-dimensional optokinetic analysis using Qualisys system

  24. Mobility abilities of willing patients recruited in the Nîmes center during drop jumps

    Time frame: Month 3

    Three-dimensional optokinetic analysis using Qualisys system

  25. Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test

    Time frame: Month 3

    Three-dimensional optokinetic analysis using Qualisys system

  26. Moderate-to-vigorous physical activity level of willing patients recruited in the Nîmes center over 7 days

    Time frame: Baseline

    Measured using an accelerometer (ActiGraph, GTX3), minutes

  27. Moderate-to-vigorous physical activity level of willing patients recruited in the Nîmes center over 7 days

    Time frame: Month 3

    Measured using an accelerometer (ActiGraph, GTX3), minutes

  28. Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days

    Time frame: Baseline

    Periods of walking >10 seconds

  29. Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days

    Time frame: Month 3

    Periods of walking >10 seconds

  30. Number of steps of willing patients recruited in the Nîmes center over 7 days

    Time frame: Baseline

    Number, measured using an accelerometer (ActiGraph, GTX3)

  31. Number of steps of willing patients recruited in the Nîmes center over 7 days

    Time frame: Month 3

    Number, measured using an accelerometer (ActiGraph, GTX3)

  32. Duration of a walking period of willing patients recruited in the Nîmes center over 7 days

    Time frame: Baseline

    Minutes, measured using an accelerometer (ActiGraph, GTX3)

  33. Duration of a walking period of willing patients recruited in the Nîmes center over 7 days

    Time frame: Month 3

    Minutes, measured using an accelerometer (ActiGraph, GTX3)

  34. Walking speed of willing patients recruited in the Nîmes center

    Time frame: Baseline

    Km/hour

  35. Walking speed of willing patients recruited in the Nîmes center

    Time frame: Month 3

    Km/hour

  36. Length of strides of willing patients recruited in the Nîmes center

    Time frame: Baseline

    Measured using an accelerometer (ActiGraph, GTX3)

  37. Length of strides of willing patients recruited in the Nîmes center

    Time frame: Month 3

    Measured using an accelerometer (ActiGraph, GTX3)

  38. Duration of strides of willing patients recruited in the Nîmes center

    Time frame: Baseline

    Measured using an accelerometer (ActiGraph, GTX3)

  39. Duration of strides of willing patients recruited in the Nîmes center

    Time frame: Month 3

    Measured using an accelerometer (ActiGraph, GTX3)

  40. Frequency of strides

    Time frame: Baseline

    Medio-lateral and antero-posterior, measured using an accelerometer (ActiGraph, GTX3)

  41. Frequency of strides

    Time frame: Month 3

    Medio-lateral and antero-posterior, measured using an accelerometer (ActiGraph, GTX3)

  42. Acceleration of willing patients recruited in the Nîmes center

    Time frame: Baseline

    Root mean square of the variability of the amplitude of acceleration, measured using an accelerometer (ActiGraph, GTX3)

  43. Acceleration of willing patients recruited in the Nîmes center

    Time frame: Month 3

    Root mean square of the variability of the amplitude of acceleration, measured using an accelerometer (ActiGraph, GTX3)

  44. Gait regularity of willing patients recruited in the Nîmes center

    Time frame: Baseline

    measured using an accelerometer (ActiGraph, GTX3)

  45. Gait regularity of willing patients recruited in the Nîmes center

    Time frame: Month 3

    measured using an accelerometer (ActiGraph, GTX3)

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud Dupeyron

CONTACT

[email protected]

04.66.68.34.59

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: APPROCHE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 4, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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