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

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: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Pain Neuroscience Education; Other: Conventional education

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie Wieczorek, MD,PhD; Phone Number: +33 0320445962; Email: valerie.wieczorek@chru-lille.fr

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • Hop Swynghedauw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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).	At 3 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Société Française de Physiothérapie (SFP).
• Investigators: Principal Investigator: Valérie Wieczorek, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 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 (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Pain; Chronic Low Back Pain; Pain Neuroscience Education; Therapeutic Patient Education; Pain Neurophysiology Education; Pain biology education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• 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