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

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pain Neuroscience Education
Conventional education
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Therapeutic Patient Education, Chronic Low Back Pain, Chronic Pain, Pain Neuroscience Education, Pain Neurophysiology Education, Pain biology education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hop SwynghedauwRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pain neuroscience education

Conventional education

Arm Description

patient receiving a "classical" education on spinal physiology and ergonomics

Outcomes

Primary Outcome Measures

Functional disability level (Rolland Morris questionnaire).

Secondary Outcome Measures

Pain rating (Numeric scale)
Functional disability level (Rolland Morris questionnaire)
Functional disability level (Dallas questionnaire)
Negatives believes level (Fear Avoidance and Belief Questionnaire)
Catastrophism level (Pain Catastrophizing Questionnaire)
Kinesiophobia level (Tampa Scale of Kinesiophobia)
Anxiety and Depression level (Hospital Anxiety and Depression scale)
Satisfaction level (18-item of Patient Satisfaction Questionnaire)
semi-conductive interview

Full Information

First Posted
November 25, 2019
Last Updated
January 25, 2023
Sponsor
University Hospital, Lille
Collaborators
Société Française de Physiothérapie (SFP).
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1. Study Identification

Unique Protocol Identification Number
NCT04179708
Brief Title
Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain
Acronym
EVAL-PNE
Official Title
Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain : A Randomized Monocentric Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Société Française de Physiothérapie (SFP).

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Therapeutic Patient Education, Chronic Low Back Pain, Chronic Pain, Pain Neuroscience Education, Pain Neurophysiology Education, Pain biology education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pain neuroscience education
Arm Type
Experimental
Arm Title
Conventional education
Arm Type
Active Comparator
Arm Description
patient receiving a "classical" education on spinal physiology and ergonomics
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Conventional education
Intervention Description
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).
Primary Outcome Measure Information:
Title
Functional disability level (Rolland Morris questionnaire).
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Pain rating (Numeric scale)
Time Frame
at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Title
Functional disability level (Rolland Morris questionnaire)
Time Frame
at baseline (pre intervention), at 5 days (post intervention) and at 1 year
Title
Functional disability level (Dallas questionnaire)
Time Frame
at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Title
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
Title
Catastrophism level (Pain Catastrophizing Questionnaire)
Time Frame
at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Title
Kinesiophobia level (Tampa Scale of Kinesiophobia)
Time Frame
at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Title
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
Title
Satisfaction level (18-item of Patient Satisfaction Questionnaire)
Time Frame
At one year
Title
semi-conductive interview
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie Wieczorek, MD,PhD
Phone
0320445962
Ext
+33
Email
valerie.wieczorek@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Wieczorek, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Swynghedauw
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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