NCT04179708

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

November 25, 2019

Last Update Submit

December 16, 2025

Conditions

Keywords

Therapeutic Patient EducationChronic Low Back PainChronic PainPain Neuroscience EducationPain Neurophysiology EducationPain biology education

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

EXPERIMENTAL
Other: Pain Neuroscience EducationOther: Conventional education

Conventional education

ACTIVE COMPARATOR

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

Other: Conventional education

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).

pain neuroscience 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).

Conventional educationpain neuroscience education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valérie Wieczorek, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

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

Locations