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Completed

NCT Number: NCT04179708

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

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

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Key information

Conditions

Chronic Low-back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Swynghedauw

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain neuroscience education

Other

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).

Conventional education

Other

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 outcomes

  1. Functional disability level (Rolland Morris questionnaire).

    Time frame: At 3 months

Secondary outcomes

  1. Pain rating (Numeric scale)

    Time frame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year

  2. Functional disability level (Rolland Morris questionnaire)

    Time frame: at baseline (pre intervention), at 5 days (post intervention) and at 1 year

  3. Functional disability level (Dallas questionnaire)

    Time frame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year

  4. 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

  5. Catastrophism level (Pain Catastrophizing Questionnaire)

    Time frame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year

  6. Kinesiophobia level (Tampa Scale of Kinesiophobia)

    Time frame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year

  7. 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

  8. Satisfaction level (18-item of Patient Satisfaction Questionnaire)

    Time frame: At one year

  9. semi-conductive interview

    Time frame: At 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Société Française de Physiothérapie (SFP).

Registry information

Official study title

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

Acronym: EVAL-PNE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2019
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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