Predictive Factors for the Success of Rehabilitation Programs in Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 333
- Locations
- 6
- Primary Endpoint
- Patient age
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Patients recruited from Nîmes center
Intervention: mobility skills testing session (Other)
Outcomes
Primary Outcomes
Patient age
Time Frame: Baseline
Years
Professional Life Satisfaction Scale Socio-economic level
Time Frame: Baseline
Scoliosis
Time Frame: Baseline
Cobb angle
Knowledge about low back pain
Time Frame: Baseline
Back Beliefs Questionnaire
Number and severity of discopathies
Time Frame: Baseline
Pfirmann classification, measured on MRI
Modic changes on MRI
Time Frame: Baseline
Present/Absent
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.
Anxiety and depression
Time Frame: Baseline
Hospital Anxiety and Depression Scale
Mobility
Time Frame: Baseline
Schöber test Finger-to-ground distance
Static endurance of the abdominal muscles
Time Frame: Baseline
Shirado test, seconds
Isometric endurance of hip and back extensor muscles
Time Frame: Baseline
Sorensen test, seconds
Central Sensitization
Time Frame: Baseline
Central Sensitization Inventory
Location of pain
Time Frame: Baseline
Patient-described using a body diagram
Patient Body Mass Index
Time Frame: Baseline
Kg/m2
Pain duration
Time Frame: Baseline
Months
Narrow lumbar canal
Time Frame: Baseline
Yes/No, Measured on MRI
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.
Work stoppage
Time Frame: Baseline
Yes/No
Work accident
Time Frame: Baseline
Yes/No
Patient sex
Time Frame: Baseline
Male/female
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).
Professional situation
Time Frame: Baseline
Description of profession
Marital status
Time Frame: Baseline
Number of children
Time Frame: Baseline
Number
Disability
Time Frame: Baseline
Yes/No
Postural disorder
Time Frame: Baseline
Yes/No
Kinesiophobia
Time Frame: Baseline
Tampa scale
Coping strategies
Time Frame: Baseline
Coping Strategies Questionnaire
Avoidance Beliefs
Time Frame: Baseline
Fear-Avoidance Beliefs Questionnaire
Self-efficacy
Time Frame: Baseline
Pain Self-Efficacy Questionnaire
Catastrophism
Time Frame: Baseline
Pain Catastrophizing Scale
Acceptance
Time Frame: Baseline
Acceptance and Action Questionnaire
Sagittal balance
Time Frame: Baseline
Measured using weight-bearing x-rays
Physical Activity
Time Frame: Baseline
International Physical Activity Questionnaire
Exercise Adherence Rating Scale Sleep
Time Frame: Baseline
Pittsburgh Questionnaire
Smoking
Time Frame: Baseline
Alcohol consumption
Time Frame: Baseline
Drug use
Time Frame: Baseline
Yes/No
Treatment pathway
Time Frame: Baseline
Description of previous physiotherapy treatments, infiltrations, osteopathy/manual therapy, medicinal treatments
Secondary Outcomes
- Duration of strides of willing patients recruited in the Nîmes center(Month 3)
- Frequency of strides(Month 3)
- Level of disability(Month 1)
- Level of disability(Month 3)
- Level of pain(Month 1)
- Level of pain(Month 3)
- Level of pain(Month 6)
- Patient-reported health-related quality of life(Baseline)
- Patient-reported health-related quality of life(Month 1)
- Patient-reported health-related quality of life(Month 3)
- Patient-reported health-related quality of life(Month 6)
- Patients' feelings about symptoms(Month 1)
- Patients' feelings about symptoms(Month 3)
- Patients' feelings about symptoms(Month 6)
- Mobility abilities of willing patients recruited in the Nîmes center during walking(Baseline)
- Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations(Baseline)
- Mobility abilities of willing patients recruited in the Nîmes center during drop jumps(Baseline)
- Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test(Baseline)
- Moderate-to-vigorous physical activity level of willing patients recruited in the Nîmes center over 7 days(Baseline)
- Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days(Baseline)
- Number of steps of willing patients recruited in the Nîmes center over 7 days(Baseline)
- Duration of a walking period of willing patients recruited in the Nîmes center over 7 days(Baseline)
- Walking speed of willing patients recruited in the Nîmes center(Baseline)
- Length of strides of willing patients recruited in the Nîmes center(Baseline)
- Duration of strides of willing patients recruited in the Nîmes center(Baseline)
- Frequency of strides(Baseline)
- Acceleration of willing patients recruited in the Nîmes center(Baseline)
- Gait regularity of willing patients recruited in the Nîmes center(Baseline)
- Moderate-to-vigorous physical activity level of willing patients recruited in the Nîmes center over 7 days(Month 3)
- Accelerometric parameters of willing patients recruited in the Nîmes center of walking over 7 days(Month 3)
- Length of strides of willing patients recruited in the Nîmes center(Month 3)
- Level of disability(Month 12)
- Level of pain(Month 12)
- Patient-reported health-related quality of life(Month 12)
- Return to work(Month 12)
- Patients' feelings about symptoms(Month 12)
- Mobility abilities of willing patients recruited in the Nîmes center during walking(Month 3)
- Mobility abilities of willing patients recruited in the Nîmes center during trunk lateral rotations(Month 3)
- Mobility abilities of willing patients recruited in the Nîmes center during drop jumps(Month 3)
- Mobility abilities of willing patients recruited in the Nîmes center during Star Excursion Balance Test(Month 3)
- Number of steps of willing patients recruited in the Nîmes center over 7 days(Month 3)
- Duration of a walking period of willing patients recruited in the Nîmes center over 7 days(Month 3)
- Walking speed of willing patients recruited in the Nîmes center(Month 3)
- Acceleration of willing patients recruited in the Nîmes center(Month 3)
- Gait regularity of willing patients recruited in the Nîmes center(Month 3)