Low Back Pain
Conditions
Keywords
Biomarkers
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.
Interventions
OTHERmobility skills testing session
A mobility skills testing session using the Qualisys system (Trinoma), when carrying out specific tasks plus 7-day recording of activity using an accelerometer.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinesiophobia | Baseline | Tampa scale |
| Level of disability | 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. |
| Patient age | Baseline | Years |
| Patient sex | Baseline | Male/female |
| Patient Body Mass Index | Baseline | Kg/m2 |
| Comorbidities | Baseline | List of medical pathologies and history of other pathologies of the musculoskeletal system (peripheral osteoarthritis, trauma to the musculoskeletal system, other musculoskeletal disorders). |
| Pain duration | Baseline | Months |
| Professional situation | Baseline | Description of profession |
| Work stoppage | Baseline | Yes/No |
| Work accident | Baseline | Yes/No |
| Disability | Baseline | Yes/No |
| Professional Life Satisfaction Scale Socio-economic level | Baseline | — |
| Marital status | Baseline | — |
| Number of children | Baseline | Number |
| Anxiety and depression | Baseline | Hospital Anxiety and Depression Scale |
| Mobility | Baseline | Schöber test Finger-to-ground distance |
| Static endurance of the abdominal muscles | Baseline | Shirado test, seconds |
| Isometric endurance of hip and back extensor muscles | Baseline | Sorensen test, seconds |
| Central Sensitization | Baseline | Central Sensitization Inventory |
| Location of pain | Baseline | Patient-described using a body diagram |
| Number and severity of discopathies | Baseline | Pfirmann classification, measured on MRI |
| Modic changes on MRI | Baseline | Present/Absent |
| Narrow lumbar canal | Baseline | Yes/No, Measured on MRI |
| Postural disorder | Baseline | Yes/No |
| Scoliosis | Baseline | Cobb angle |
| Sagittal balance | Baseline | Measured using weight-bearing x-rays |
| Physical Activity | Baseline | International Physical Activity Questionnaire |
| Exercise Adherence Rating Scale Sleep | Baseline | Pittsburgh Questionnaire |
| Smoking | Baseline | — |
| Alcohol consumption | Baseline | — |
| Drug use | Baseline | Yes/No |
| Knowledge about low back pain | Baseline | Back Beliefs Questionnaire |
| Treatment pathway | Baseline | Description of previous physiotherapy treatments, infiltrations, osteopathy/manual therapy, medicinal treatments |
| Coping strategies | Baseline | Coping Strategies Questionnaire |
| Avoidance Beliefs | Baseline | Fear-Avoidance Beliefs Questionnaire |
| Self-efficacy | Baseline | Pain Self-Efficacy Questionnaire |
| Catastrophism | Baseline | Pain Catastrophizing Scale |
| Acceptance | Baseline | Acceptance and Action Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait regularity of willing patients recruited in the Nîmes center | Baseline | measured using an accelerometer (ActiGraph, GTX3) |
| Duration of a walking period of willing patients recruited in the Nîmes center over 7 days | Baseline | Minutes, measured using an accelerometer (ActiGraph, GTX3) |
| Walking speed of willing patients recruited in the Nîmes center | Baseline | Km/hour |
| Length of strides of willing patients recruited in the Nîmes center | Baseline | Measured using an accelerometer (ActiGraph, GTX3) |
| Duration of strides of willing patients recruited in the Nîmes center | Baseline | Measured using an accelerometer (ActiGraph, GTX3) |
| Frequency of strides | Baseline | Medio-lateral and antero-posterior, measured using an accelerometer (ActiGraph, GTX3) |
| Acceleration of willing patients recruited in the Nîmes center | Baseline | Root mean square of the variability of the amplitude of acceleration, measured using an accelerometer (ActiGraph, GTX3) |
| Level of disability | 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. |
| Level of pain | Month 1 | Visual Analog Scale, 0-100 |
| Patient-reported health-related quality of life | Baseline | Quality of life questionnaire EQ-5D questionnaire, score 0-100 |
| Return to work | Month 12 | Number of days until return to work after end of physiotherapy program |
| Patients' feelings about symptoms | Month 1 | PGI-C (Patient Global Impression of Change) questionnaire, score 1-7 |
| Mobility abilities of willing patients recruited in the Nîmes center during walking | Baseline | Three-dimensional optokinetic analysis using Qualisys system |
| Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations | Baseline | Three-dimensional optokinetic analysis using Qualisys system |
| Mobility abilities of willing patients recruited in the Nîmes center during drop jumps | Baseline | Three-dimensional optokinetic analysis using Qualisys system |
| Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test | Baseline | Three-dimensional optokinetic analysis using Qualisys system |
| Moderate-to-vigorous physical activity level of willing patients recruited in the Nîmes center over 7 days | Baseline | Measured using an accelerometer (ActiGraph, GTX3), minutes |
| Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days | Baseline | Periods of walking \>10 seconds |
| Number of steps of willing patients recruited in the Nîmes center over 7 days | Baseline | Number, measured using an accelerometer (ActiGraph, GTX3) |
Countries
France
Contacts
CONTACTArnaud Dupeyron
PRINCIPAL_INVESTIGATORArnaud Dupeyron
CHU de Nimes
Outcome results
None listed