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.
Study Type
OBSERVATIONAL
Enrollment
333
A mobility skills testing session using the Qualisys system (Trinoma), when carrying out specific tasks plus 7-day recording of activity using an accelerometer.
CHU de Clermont Ferrand
Clermont-Ferrand, Auvergne, France
NOT_YET_RECRUITINGCentre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France
NOT_YET_RECRUITINGCHU de Montpellier
Montpellier, Occitanie, France
NOT_YET_RECRUITINGCHU de Nîmes
Nîmes, Occitanie, France
RECRUITINGCHU de Clermont-Ferrand
Clermont-Ferrand, France
NOT_YET_RECRUITINGCHU de Montpellier
Montpellier, France
NOT_YET_RECRUITINGLevel 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.
Time frame: 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.
Time frame: Month 6
Patient age
Years
Time frame: Baseline
Patient sex
Male/female
Time frame: Baseline
Patient Body Mass Index
Kg/m2
Time frame: 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).
Time frame: Baseline
Pain duration
Months
Time frame: Baseline
Professional situation
Description of profession
Time frame: Baseline
Work stoppage
Yes/No
Time frame: Baseline
Work accident
Yes/No
Time frame: Baseline
Disability
Yes/No
Time frame: Baseline
Professional Life Satisfaction Scale Socio-economic level
Time frame: Baseline
Marital status
Time frame: Baseline
Number of children
Number
Time frame: Baseline
Kinesiophobia
Tampa scale
Time frame: Baseline
Coping strategies
Coping Strategies Questionnaire
Time frame: Baseline
Avoidance Beliefs
Fear-Avoidance Beliefs Questionnaire
Time frame: Baseline
Self-efficacy
Pain Self-Efficacy Questionnaire
Time frame: Baseline
Catastrophism
Pain Catastrophizing Scale
Time frame: Baseline
Acceptance
Acceptance and Action Questionnaire
Time frame: Baseline
Anxiety and depression
Hospital Anxiety and Depression Scale
Time frame: Baseline
Mobility
Schöber test Finger-to-ground distance
Time frame: Baseline
Static endurance of the abdominal muscles
Shirado test, seconds
Time frame: Baseline
Isometric endurance of hip and back extensor muscles
Sorensen test, seconds
Time frame: Baseline
Central Sensitization
Central Sensitization Inventory
Time frame: Baseline
Location of pain
Patient-described using a body diagram
Time frame: Baseline
Number and severity of discopathies
Pfirmann classification, measured on MRI
Time frame: Baseline
Modic changes on MRI
Present/Absent
Time frame: Baseline
Narrow lumbar canal
Yes/No, Measured on MRI
Time frame: Baseline
Postural disorder
Yes/No
Time frame: Baseline
Scoliosis
Cobb angle
Time frame: Baseline
Sagittal balance
Measured using weight-bearing x-rays
Time frame: Baseline
Physical Activity
International Physical Activity Questionnaire
Time frame: Baseline
Exercise Adherence Rating Scale Sleep
Pittsburgh Questionnaire
Time frame: Baseline
Smoking
Time frame: Baseline
Alcohol consumption
Time frame: Baseline
Drug use
Yes/No
Time frame: Baseline
Knowledge about low back pain
Back Beliefs Questionnaire
Time frame: Baseline
Treatment pathway
Description of previous physiotherapy treatments, infiltrations, osteopathy/manual therapy, medicinal treatments
Time frame: 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.
Time frame: Month 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.
Time frame: 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.
Time frame: Month 12
Level of pain
Visual Analog Scale, 0-100
Time frame: Month 1
Level of pain
Visual Analog Scale, 0-100
Time frame: Month 3
Level of pain
Visual Analog Scale, 0-100
Time frame: Month 6
Level of pain
Visual Analog Scale, 0-100
Time frame: Month 12
Patient-reported health-related quality of life
Quality of life questionnaire EQ-5D questionnaire, score 0-100
Time frame: Baseline
Patient-reported health-related quality of life
EQ-5D questionnaire, score 0-100
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Month 1
Patient-reported health-related quality of life
Quality of life questionnaire EQ-5D questionnaire, score 0-100
Time frame: Month 3
Patient-reported health-related quality of life
EQ-5D questionnaire, score 0-100
Time frame: Month 6
Patient-reported health-related quality of life
EQ-5D questionnaire, score 0-100
Time frame: Month 12
Return to work
Number of days until return to work after end of physiotherapy program
Time frame: Month 12
Patients' feelings about symptoms
PGI-C (Patient Global Impression of Change) questionnaire, score 1-7
Time frame: Month 1
Patients' feelings about symptoms
PGI-C (Patient Global Impression of Change) questionnaire, score 1-7
Time frame: Month 3
Patients' feelings about symptoms
PGI-C (Patient Global Impression of Change) questionnaire, score 1-7
Time frame: Month 6
Patients' feelings about symptoms
PGI-C (Patient Global Impression of Change) questionnaire, score 1-7
Time frame: Month 12
Mobility abilities of willing patients recruited in the Nîmes center during walking
Three-dimensional optokinetic analysis using Qualisys system
Time frame: Baseline
Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations
Three-dimensional optokinetic analysis using Qualisys system
Time frame: Baseline
Mobility abilities of willing patients recruited in the Nîmes center during drop jumps
Three-dimensional optokinetic analysis using Qualisys system
Time frame: Baseline
Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test
Three-dimensional optokinetic analysis using Qualisys system
Time frame: Baseline
Mobility abilities of willing patients recruited in the Nîmes center during walking
Three-dimensional optokinetic analysis using Qualisys system
Time frame: Month 3
Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations
Three-dimensional optokinetic analysis using Qualisys system
Time frame: Month 3
Mobility abilities of willing patients recruited in the Nîmes center during drop jumps
Three-dimensional optokinetic analysis using Qualisys system
Time frame: Month 3
Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test
Three-dimensional optokinetic analysis using Qualisys system
Time frame: 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
Time frame: 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
Time frame: Month 3
Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days
Periods of walking \>10 seconds
Time frame: Baseline
Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days
Periods of walking \>10 seconds
Time frame: Month 3
Number of steps of willing patients recruited in the Nîmes center over 7 days
Number, measured using an accelerometer (ActiGraph, GTX3)
Time frame: Baseline
Number of steps of willing patients recruited in the Nîmes center over 7 days
Number, measured using an accelerometer (ActiGraph, GTX3)
Time frame: 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)
Time frame: Baseline
Duration of a walking period of willing patients recruited in the Nîmes center over 7 days
Minutes, measured using an accelerometer (ActiGraph, GTX3)
Time frame: Month 3
Walking speed of willing patients recruited in the Nîmes center
Km/hour
Time frame: Baseline
Walking speed of willing patients recruited in the Nîmes center
Km/hour
Time frame: Month 3
Length of strides of willing patients recruited in the Nîmes center
Measured using an accelerometer (ActiGraph, GTX3)
Time frame: Baseline
Length of strides of willing patients recruited in the Nîmes center
Measured using an accelerometer (ActiGraph, GTX3)
Time frame: Month 3
Duration of strides of willing patients recruited in the Nîmes center
Measured using an accelerometer (ActiGraph, GTX3)
Time frame: Baseline
Duration of strides of willing patients recruited in the Nîmes center
Measured using an accelerometer (ActiGraph, GTX3)
Time frame: Month 3
Frequency of strides
Medio-lateral and antero-posterior, measured using an accelerometer (ActiGraph, GTX3)
Time frame: Baseline
Frequency of strides
Medio-lateral and antero-posterior, measured using an accelerometer (ActiGraph, GTX3)
Time frame: 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)
Time frame: 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)
Time frame: Month 3
Gait regularity of willing patients recruited in the Nîmes center
measured using an accelerometer (ActiGraph, GTX3)
Time frame: Baseline
Gait regularity of willing patients recruited in the Nîmes center
measured using an accelerometer (ActiGraph, GTX3)
Time frame: Month 3