Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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The hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education.

Official Title
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Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain : A Randomized Monocentric Trial.

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Pain Neuroscience Education
* Other: Conventional education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low Back Pain since more than 1 year Affiliated to Social Security Scheme Rolland Moris ≥ 8 Start Back ≥ 4 Exclusion Criteria: Suspicion or proven case of serious pathology such as recent vertebral fracture (less than 6 months), infection, malignant tumors and / or radiculopathy. Have a history of rheumatic inflammatory disease Have a true radiculalgia (with or without radiculopathy) Have a scoliosis > 30° (if it is considered as a predominant contributor of pain's persistence). Rating of pain > 8/10 Have had lumbar surgery in the past 12 months Have had an injection in the past 3 months Patients under legal protection (guardianship, curatorship) Pregnant patients Patients who are not able to understand, read or speak french Inability to receive informed information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pain neuroscience education<br> | Other: Pain Neuroscience Education<br>* Intervention description Patients participate in a back school program including initial and final assessment, educational activities and therapeutic activities (eg. Physiotherapy, balneotherapy, physical activity, spine ergonomics, and so on) spread over 5 days. The therapeutic activities are the same in experimental and control group, only the educational activities differ. The educational activities represent 4 hours of intervention, ½ hours of educative initial assessment and ½ hour of educative final assessment. The content of Pain Neuroscience Education (experimental group) focuses on deconstruction of patho-anatomical and biomechanical believes, and the explanation of pain from the biology. This framework allows the introduction of coping strategies (eg gradual exposure to exercise, activity and physical activity) and regulation strategy (eg fragmentation of activity, stress management, and so on).<br>Other: Conventional education<br>* assessment, educational activities and therapeutic activities (eg. Physiotherapy, balneotherapy, physical activity, spine ergonomics, and so on) spread over 5 days. The therapeutic activities are the same in experimental and control group, only the educational activities differ. The educational activities represent 4 hours of intervention, ½ hour of educative initial assessment and ½ hour of educative final assessment. The content of conventional education (control grou) focuses on patho-anatomical and biomechanical notions. This framework allows the introduction of protection strategies (eg education on good posture, good handling techniques, physical activity and therapeutic exercise in stretch and strenghten the spine in order to protect it).<br>|
| Active Comparator: Conventional education<br>patient receiving a classical education on spinal physiology and ergonomics | Other: Conventional education<br>* assessment, educational activities and therapeutic activities (eg. Physiotherapy, balneotherapy, physical activity, spine ergonomics, and so on) spread over 5 days. The therapeutic activities are the same in experimental and control group, only the educational activities differ. The educational activities represent 4 hours of intervention, ½ hour of educative initial assessment and ½ hour of educative final assessment. The content of conventional education (control grou) focuses on patho-anatomical and biomechanical notions. This framework allows the introduction of protection strategies (eg education on good posture, good handling techniques, physical activity and therapeutic exercise in stretch and strenghten the spine in order to protect it).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional disability level (Rolland Morris questionnaire). |  | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rating (Numeric scale) |  | at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year | 
| Functional disability level (Rolland Morris questionnaire) |  | at baseline (pre intervention), at 5 days (post intervention) and at 1 year | 
| Functional disability level (Dallas questionnaire) |  | at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year | 
| Negatives believes level (Fear Avoidance and Belief Questionnaire) |  | at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year | 
| Catastrophism level (Pain Catastrophizing Questionnaire) |  | at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year | 
| Kinesiophobia level (Tampa Scale of Kinesiophobia) |  | at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year | 
| Anxiety and Depression level (Hospital Anxiety and Depression scale) |  | at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year | 
| Satisfaction level (18-item of Patient Satisfaction Questionnaire) |  | At one year | 
| semi-conductive interview |  | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Patient Education, Chronic Low Back Pain, Chronic Pain, Pain Neuroscience Education, Pain Neurophysiology Education, Pain biology education