Predictive Factors for the Success of Rehabilitation Programs in Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 333
- 试验地点
- 6
- 主要终点
- Patient age
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Patients recruited from Nîmes center
干预措施: mobility skills testing session (Other)
结局指标
主要结局
Patient age
时间窗: Baseline
Years
Professional Life Satisfaction Scale Socio-economic level
时间窗: Baseline
Scoliosis
时间窗: Baseline
Cobb angle
Knowledge about low back pain
时间窗: Baseline
Back Beliefs Questionnaire
Number and severity of discopathies
时间窗: Baseline
Pfirmann classification, measured on MRI
Modic changes on MRI
时间窗: Baseline
Present/Absent
Level of disability
时间窗: 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
时间窗: Baseline
Hospital Anxiety and Depression Scale
Mobility
时间窗: Baseline
Schöber test Finger-to-ground distance
Static endurance of the abdominal muscles
时间窗: Baseline
Shirado test, seconds
Isometric endurance of hip and back extensor muscles
时间窗: Baseline
Sorensen test, seconds
Central Sensitization
时间窗: Baseline
Central Sensitization Inventory
Location of pain
时间窗: Baseline
Patient-described using a body diagram
Patient Body Mass Index
时间窗: Baseline
Kg/m2
Pain duration
时间窗: Baseline
Months
Narrow lumbar canal
时间窗: Baseline
Yes/No, Measured on MRI
Level of disability
时间窗: 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
时间窗: Baseline
Yes/No
Work accident
时间窗: Baseline
Yes/No
Patient sex
时间窗: Baseline
Male/female
Comorbidities
时间窗: 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
时间窗: Baseline
Description of profession
Marital status
时间窗: Baseline
Number of children
时间窗: Baseline
Number
Disability
时间窗: Baseline
Yes/No
Postural disorder
时间窗: Baseline
Yes/No
Kinesiophobia
时间窗: Baseline
Tampa scale
Coping strategies
时间窗: Baseline
Coping Strategies Questionnaire
Avoidance Beliefs
时间窗: Baseline
Fear-Avoidance Beliefs Questionnaire
Self-efficacy
时间窗: Baseline
Pain Self-Efficacy Questionnaire
Catastrophism
时间窗: Baseline
Pain Catastrophizing Scale
Acceptance
时间窗: Baseline
Acceptance and Action Questionnaire
Sagittal balance
时间窗: Baseline
Measured using weight-bearing x-rays
Physical Activity
时间窗: Baseline
International Physical Activity Questionnaire
Exercise Adherence Rating Scale Sleep
时间窗: Baseline
Pittsburgh Questionnaire
Smoking
时间窗: Baseline
Alcohol consumption
时间窗: Baseline
Drug use
时间窗: Baseline
Yes/No
Treatment pathway
时间窗: Baseline
Description of previous physiotherapy treatments, infiltrations, osteopathy/manual therapy, medicinal treatments
次要结局
- 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)