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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients recruited from Nîmes center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 1 |
| Level of disability |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnaud Dupeyron | Contact | 04.66.68.34.59 | arnaud.dupeyron@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Arnaud Dupeyron | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont Ferrand | Not yet recruiting | Clermont-Ferrand | Auvergne | 63000 | France |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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 |
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 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. | Month 12 |
| Level of pain | Visual Analog Scale, 0-100 | Month 1 |
| Level of pain | Visual Analog Scale, 0-100 | Month 3 |
| Level of pain | Visual Analog Scale, 0-100 | Month 6 |
| Level of pain | Visual Analog Scale, 0-100 | Month 12 |
| Patient-reported health-related quality of life | Quality of life questionnaire EQ-5D questionnaire, score 0-100 | Baseline |
| Patient-reported health-related quality of life | EQ-5D questionnaire, score 0-100 | Month 1 |
| Patient-reported health-related quality of life | Quality of life questionnaire EQ-5D questionnaire, score 0-100 | Month 3 |
| Patient-reported health-related quality of life | EQ-5D questionnaire, score 0-100 | Month 6 |
| Patient-reported health-related quality of life | EQ-5D questionnaire, score 0-100 | Month 12 |
| Return to work | Number of days until return to work after end of physiotherapy program | Month 12 |
| Patients' feelings about symptoms | PGI-C (Patient Global Impression of Change) questionnaire, score 1-7 | Month 1 |
| Patients' feelings about symptoms | PGI-C (Patient Global Impression of Change) questionnaire, score 1-7 | Month 3 |
| Patients' feelings about symptoms | PGI-C (Patient Global Impression of Change) questionnaire, score 1-7 | Month 6 |
| Patients' feelings about symptoms | PGI-C (Patient Global Impression of Change) questionnaire, score 1-7 | Month 12 |
| Mobility abilities of willing patients recruited in the Nîmes center during walking | Three-dimensional optokinetic analysis using Qualisys system | Baseline |
| Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations | Three-dimensional optokinetic analysis using Qualisys system | Baseline |
| Mobility abilities of willing patients recruited in the Nîmes center during drop jumps | Three-dimensional optokinetic analysis using Qualisys system | Baseline |
| Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test | Three-dimensional optokinetic analysis using Qualisys system | Baseline |
| Mobility abilities of willing patients recruited in the Nîmes center during walking | Three-dimensional optokinetic analysis using Qualisys system | Month 3 |
| Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations | Three-dimensional optokinetic analysis using Qualisys system | Month 3 |
| Mobility abilities of willing patients recruited in the Nîmes center during drop jumps | Three-dimensional optokinetic analysis using Qualisys system | Month 3 |
| Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test | Three-dimensional optokinetic analysis using Qualisys system | Month 3 |
| Moderate-to-vigorous physical activity level of willing patients recruited in the Nîmes center over 7 days | Measured using an accelerometer (ActiGraph, GTX3), minutes | Baseline |
| Moderate-to-vigorous physical activity level of willing patients recruited in the Nîmes center over 7 days | Measured using an accelerometer (ActiGraph, GTX3), minutes | Month 3 |
| Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days | Periods of walking >10 seconds | Baseline |
| Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days | Periods of walking >10 seconds | Month 3 |
| Number of steps of willing patients recruited in the Nîmes center over 7 days | Number, measured using an accelerometer (ActiGraph, GTX3) | Baseline |
| Number of steps of willing patients recruited in the Nîmes center over 7 days | Number, measured using an accelerometer (ActiGraph, GTX3) | Month 3 |
| Duration of a walking period of willing patients recruited in the Nîmes center over 7 days | Minutes, measured using an accelerometer (ActiGraph, GTX3) | Baseline |
| Duration of a walking period of willing patients recruited in the Nîmes center over 7 days | Minutes, measured using an accelerometer (ActiGraph, GTX3) | Month 3 |
| Walking speed of willing patients recruited in the Nîmes center | Km/hour | Baseline |
| Walking speed of willing patients recruited in the Nîmes center | Km/hour | Month 3 |
| Length of strides of willing patients recruited in the Nîmes center | Measured using an accelerometer (ActiGraph, GTX3) | Baseline |
| Length of strides of willing patients recruited in the Nîmes center | Measured using an accelerometer (ActiGraph, GTX3) | Month 3 |
| Duration of strides of willing patients recruited in the Nîmes center | Measured using an accelerometer (ActiGraph, GTX3) | Baseline |
| Duration of strides of willing patients recruited in the Nîmes center | Measured using an accelerometer (ActiGraph, GTX3) | Month 3 |
| Frequency of strides | Medio-lateral and antero-posterior, measured using an accelerometer (ActiGraph, GTX3) | Baseline |
| Frequency of strides | Medio-lateral and antero-posterior, measured using an accelerometer (ActiGraph, GTX3) | Month 3 |
| 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) | Baseline |
| 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) | Month 3 |
| Gait regularity of willing patients recruited in the Nîmes center | measured using an accelerometer (ActiGraph, GTX3) | Baseline |
| Gait regularity of willing patients recruited in the Nîmes center | measured using an accelerometer (ActiGraph, GTX3) | Month 3 |
| Centre Hospitalier Universitaire de Nîmes | Not yet recruiting | Nîmes | Gard | 30900 | France |
|
| CHU de Montpellier | Not yet recruiting | Montpellier | Occitanie | 34000 | France |
|
| CHU de Nîmes | Recruiting | Nîmes | Occitanie | 30029 | France |
|
| CHU de Clermont-Ferrand | Not yet recruiting | Clermont-Ferrand | France |
|
| CHU de Montpellier | Not yet recruiting | Montpellier | France |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |