Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain (EVAL-PNE)

December 16, 2025 updated by: University Hospital, Lille

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Hop Swynghedauw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pain neuroscience education
Other: Pain Neuroscience Education

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).

Other: Conventional education

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).
Active Comparator: Conventional education
patient receiving a "classical" education on spinal physiology and ergonomics
Other: Conventional education

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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Société Française de Physiothérapie (SFP).

Investigators

  • Principal Investigator: Valérie Wieczorek, MD,PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Actual)

February 10, 2024

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_79
  • 2019-A01260-57 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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