Predictive Factors for the Success of Rehabilitation Programs in Chronic Low Back Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

mobility 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• Level of disability — 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.
• 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
• Kinesiophobia — Baseline
  Tampa scale
• 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
• 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

Trial sites (6)

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