Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain
EVAL-PNE
2 other identifiers
interventional
88
1 country
1
Brief Summary
The hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 27, 2019
CompletedStudy Start
First participant enrolled
January 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2024
CompletedDecember 23, 2025
December 1, 2025
4.1 years
November 25, 2019
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional disability level (Rolland Morris questionnaire).
At 3 months
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
pain neuroscience education
EXPERIMENTALConventional education
ACTIVE COMPARATORpatient receiving a "classical" education on spinal physiology and ergonomics
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Low Back Pain since more than 1 year
- Affiliated to Social Security Scheme
- Rolland Moris ≥ 8
- Start Back ≥ 4
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hop Swynghedauw
Lille, 59000, France
Related Publications (1)
Adenis N, Wieczorek V, Corbinau S, Mortain L, Thevenon A. Pain neuroscience education is not superior to spinal physiology and ergonomics education within a short multidisciplinary rehabilitation program: A randomized controlled trial. Musculoskelet Sci Pract. 2024 Nov;74:103176. doi: 10.1016/j.msksp.2024.103176. Epub 2024 Sep 5.
PMID: 39260006RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valérie Wieczorek, MD,PhD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2019
First Posted
November 27, 2019
Study Start
January 6, 2020
Primary Completion
February 10, 2024
Study Completion
February 10, 2024
Last Updated
December 23, 2025
Record last verified: 2025-12