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Low Back PainAPPROCHENCT07051772

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

An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
mobility skills testing session
How many people
333 participants
Where
6 sitesFrance
Study dates
19 Feb 2025to Aug 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

France6 sites, 6 recruiting
  • CHU de Clermont Ferrand

    Clermont-Ferrand, Auvergne, 63000

    Emmanuel COUDEYRE, Pr., +33 4.73.75.09.00, ecoudeyre@chu-clermontferrand.fr

    Not yet recruiting
  • CHU de Clermont-Ferrand

    Clermont-Ferrand

    Emmanuel Coudeyre, 04.73.75.09.00, ecoudeyre@chu-clermontferrand.fr

    Not yet recruiting
  • CHU de Montpellier

    Montpellier, Occitanie, 34000

    Isabelle TAVARES, Pr., +33 4.67.33.87.17, i-tavaresfigueiredo@chu-montpellier.fr

    Not yet recruiting
  • CHU de Montpellier

    Montpellier

    Isabelle Tavares, 04.67.33.87.17, i-tavaresfigueiredo@chu-montpellier.fr

    Not yet recruiting
  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, Gard, 30900

    Anissa Megzari, Prof., 04.66.68.42.62, drc@chu-nimes.fr

    Arnaud Dupeyron

    Not yet recruiting
  • CHU de Nîmes

    Nîmes, Occitanie, 30029

    Arnaud DUPEYRON, Pr., +33 4.66.68.34.59, arnaud.dupeyron@umontpellier.fr

    Recruiting

Other trials in France

About this study

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
Being tested
mobility skills testing session
Keywords
Biomarkers
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mobility skills testing sessionOther

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

Study groups in NCT07051772
Study groupRoleWhat they receive
Patients recruited from Nîmes centerNot described
Receives: Other: mobility skills testing session

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Month 6

  3. Patient age

    Years

    Measured: Baseline

  4. Patient sex

    Male/female

    Measured: Baseline

  5. Patient Body Mass Index

    Kg/m2

    Measured: Baseline

  6. Comorbidities

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

    Measured: Baseline

  7. Pain duration

    Months

    Measured: Baseline

  8. Professional situation

    Description of profession

    Measured: Baseline

  9. Work stoppage

    Yes/No

    Measured: Baseline

  10. Work accident

    Yes/No

    Measured: Baseline

  11. Disability

    Yes/No

    Measured: Baseline

  12. Professional Life Satisfaction Scale Socio-economic level

    Measured: Baseline

  13. Marital status

    Measured: Baseline

  14. Number of children

    Number

    Measured: Baseline

  15. Kinesiophobia

    Tampa scale

    Measured: Baseline

  16. Coping strategies

    Coping Strategies Questionnaire

    Measured: Baseline

  17. Avoidance Beliefs

    Fear-Avoidance Beliefs Questionnaire

    Measured: Baseline

  18. Self-efficacy

    Pain Self-Efficacy Questionnaire

    Measured: Baseline

  19. Catastrophism

    Pain Catastrophizing Scale

    Measured: Baseline

  20. Acceptance

    Acceptance and Action Questionnaire

    Measured: Baseline

  21. Anxiety and depression

    Hospital Anxiety and Depression Scale

    Measured: Baseline

  22. Mobility

    Schöber test Finger-to-ground distance

    Measured: Baseline

  23. Static endurance of the abdominal muscles

    Shirado test, seconds

    Measured: Baseline

  24. Isometric endurance of hip and back extensor muscles

    Sorensen test, seconds

    Measured: Baseline

  25. Central Sensitization

    Central Sensitization Inventory

    Measured: Baseline

  26. Location of pain

    Patient-described using a body diagram

    Measured: Baseline

  27. Number and severity of discopathies

    Pfirmann classification, measured on MRI

    Measured: Baseline

  28. Modic changes on MRI

    Present/Absent

    Measured: Baseline

  29. Narrow lumbar canal

    Yes/No, Measured on MRI

    Measured: Baseline

  30. Postural disorder

    Yes/No

    Measured: Baseline

  31. Scoliosis

    Cobb angle

    Measured: Baseline

  32. Sagittal balance

    Measured using weight-bearing x-rays

    Measured: Baseline

  33. Physical Activity

    International Physical Activity Questionnaire

    Measured: Baseline

  34. Exercise Adherence Rating Scale Sleep

    Pittsburgh Questionnaire

    Measured: Baseline

  35. Smoking

    Measured: Baseline

  36. Alcohol consumption

    Measured: Baseline

  37. Drug use

    Yes/No

    Measured: Baseline

  38. Knowledge about low back pain

    Back Beliefs Questionnaire

    Measured: Baseline

  39. Treatment pathway

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

    Measured: Baseline

Secondary outcomes (45)
  1. 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.

    Measured: Month 1

  2. 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.

    Measured: Month 3

  3. 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.

    Measured: Month 12

  4. Level of pain

    Visual Analog Scale, 0-100

    Measured: Month 1

  5. Level of pain

    Visual Analog Scale, 0-100

    Measured: Month 3

  6. Level of pain

    Visual Analog Scale, 0-100

    Measured: Month 6

  7. Level of pain

    Visual Analog Scale, 0-100

    Measured: Month 12

  8. Patient-reported health-related quality of life

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

    Measured: Baseline

  9. Patient-reported health-related quality of life

    EQ-5D questionnaire, score 0-100

    Measured: Month 1

  10. Patient-reported health-related quality of life

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

    Measured: Month 3

  11. Patient-reported health-related quality of life

    EQ-5D questionnaire, score 0-100

    Measured: Month 6

  12. Patient-reported health-related quality of life

    EQ-5D questionnaire, score 0-100

    Measured: Month 12

  13. Return to work

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

    Measured: Month 12

  14. Patients' feelings about symptoms

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

    Measured: Month 1

  15. Patients' feelings about symptoms

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

    Measured: Month 3

  16. Patients' feelings about symptoms

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

    Measured: Month 6

  17. Patients' feelings about symptoms

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

    Measured: Month 12

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

    Three-dimensional optokinetic analysis using Qualisys system

    Measured: Baseline

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

    Three-dimensional optokinetic analysis using Qualisys system

    Measured: Baseline

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

    Three-dimensional optokinetic analysis using Qualisys system

    Measured: Baseline

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

    Three-dimensional optokinetic analysis using Qualisys system

    Measured: Baseline

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

    Three-dimensional optokinetic analysis using Qualisys system

    Measured: Month 3

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

    Three-dimensional optokinetic analysis using Qualisys system

    Measured: Month 3

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

    Three-dimensional optokinetic analysis using Qualisys system

    Measured: Month 3

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

    Three-dimensional optokinetic analysis using Qualisys system

    Measured: Month 3

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

    Measured using an accelerometer (ActiGraph, GTX3), minutes

    Measured: Baseline

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

    Measured using an accelerometer (ActiGraph, GTX3), minutes

    Measured: Month 3

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

    Periods of walking >10 seconds

    Measured: Baseline

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

    Periods of walking >10 seconds

    Measured: Month 3

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

    Number, measured using an accelerometer (ActiGraph, GTX3)

    Measured: Baseline

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

    Number, measured using an accelerometer (ActiGraph, GTX3)

    Measured: Month 3

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

    Minutes, measured using an accelerometer (ActiGraph, GTX3)

    Measured: Baseline

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

    Minutes, measured using an accelerometer (ActiGraph, GTX3)

    Measured: Month 3

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

    Km/hour

    Measured: Baseline

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

    Km/hour

    Measured: Month 3

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

    Measured using an accelerometer (ActiGraph, GTX3)

    Measured: Baseline

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

    Measured using an accelerometer (ActiGraph, GTX3)

    Measured: Month 3

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

    Measured using an accelerometer (ActiGraph, GTX3)

    Measured: Baseline

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

    Measured using an accelerometer (ActiGraph, GTX3)

    Measured: Month 3

  40. Frequency of strides

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

    Measured: Baseline

  41. Frequency of strides

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

    Measured: Month 3

  42. Acceleration of willing patients recruited in the Nîmes center

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

    Measured: Baseline

  43. Acceleration of willing patients recruited in the Nîmes center

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

    Measured: Month 3

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

    measured using an accelerometer (ActiGraph, GTX3)

    Measured: Baseline

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

    measured using an accelerometer (ActiGraph, GTX3)

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start19 Feb 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
333 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07051772
Sponsor's protocol ID
NIMAO/2023-1/AD-01
Acronym
APPROCHE
Status last verified
Jan 2026
First submitted
6 Mar 2025
Last updated
16 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arnaud Dupeyron (04.66.68.34.59, arnaud.dupeyron@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of disability (time frame: Baseline). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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