Chronic Low-back PainEVAL-PNENCT04179708
Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain
A study testing Pain Neuroscience Education and Conventional education in people with Chronic Low-back Pain, run by University Hospital, Lille at 1 site in France.
Trial summary
The hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Pain Neuroscience Education and Conventional education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2020to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low Back Pain since more than 1 year
- Affiliated to Social Security Scheme
- Rolland Moris ≥ 8
- Start Back ≥ 4
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Pain Neuroscience Education, Conventional education
- Keywords
- Therapeutic Patient Education, Chronic Low Back Pain, Chronic Pain, Pain Neuroscience Education, Pain Neurophysiology Education, Pain biology education
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
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 educationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| pain neuroscience education | Experimental | Not described Receives: Other: Pain Neuroscience Education; Other: Conventional education |
| Conventional education | Active comparator | patient receiving a "classical" education on spinal physiology and ergonomics Receives: Other: Conventional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional disability level (Rolland Morris questionnaire).
Measured: At 3 months
Secondary outcomes (9)
Pain rating (Numeric scale)
Measured: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Functional disability level (Rolland Morris questionnaire)
Measured: at baseline (pre intervention), at 5 days (post intervention) and at 1 year
Functional disability level (Dallas questionnaire)
Measured: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Negatives believes level (Fear Avoidance and Belief Questionnaire)
Measured: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Catastrophism level (Pain Catastrophizing Questionnaire)
Measured: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Kinesiophobia level (Tampa Scale of Kinesiophobia)
Measured: 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)
Measured: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Satisfaction level (18-item of Patient Satisfaction Questionnaire)
Measured: At one year
semi-conductive interview
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start6 Jan 2020
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française de Physiothérapie (SFP).
- Responsible party
- Sponsor
- Investigators
- Valérie Wieczorek, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179708
- Sponsor's protocol ID
- 2018_79
- Other IDs
- 2019-A01260-57
- Acronym
- EVAL-PNE
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2019
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39260006Adenis N, Wieczorek V, Corbinau S, Mortain L, Tiffreau V, Thevenon A. Pain neuroscience education versus spinal physiology and ergonomics education in multidisciplinary rehabilitation for chronic low back pain: 12-month follow-up of a randomized controlled trial. Physiother Theory Pract. 2026 Jul 22:1-12. doi: 10.1080/09593985.2026.2706161. Online ahead of print.
PubMed 42482622
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain : A Randomized Monocentric Trial.
- ClinicalTrials.gov ID
- NCT04179708
- Acronym / sponsor ID
- EVAL-PNE / 2018_79
- Conditions
- Chronic Low-back Pain
- Keywords
- Therapeutic Patient Education, Chronic Low Back Pain, Chronic Pain, Pain Neuroscience Education, Pain Neurophysiology Education, Pain biology education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Société Française de Physiothérapie (SFP).
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pain neuroscience education | Experimental | Other: Pain Neuroscience Education, Other: Conventional education |
| Conventional education | Active comparator | Other: Conventional educationpatient receiving a "classical" education on spinal physiology and ergonomics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low Back Pain since more than 1 year
- Affiliated to Social Security Scheme
- Rolland Moris ≥ 8
- Start Back ≥ 4
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience EducationIntervention 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 | pain neuroscience education |
| Conventional educationassessment, 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). | Other | Conventional education, pain neuroscience education |
Primary outcome
Functional disability level (Rolland Morris questionnaire).
Time frame: At 3 months
9 secondary outcomes
Pain rating (Numeric scale)
Time frame: 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
Functional disability level (Dallas questionnaire)
Time frame: 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
Catastrophism level (Pain Catastrophizing Questionnaire)
Time frame: 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
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
Satisfaction level (18-item of Patient Satisfaction Questionnaire)
Time frame: At one year
semi-conductive interview
Time frame: At 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 39260006Adenis 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.
- Derived from this study: PubMed 42482622Adenis N, Wieczorek V, Corbinau S, Mortain L, Tiffreau V, Thevenon A. Pain neuroscience education versus spinal physiology and ergonomics education in multidisciplinary rehabilitation for chronic low back pain: 12-month follow-up of a randomized controlled trial. Physiother Theory Pract. 2026 Jul 22:1-12. doi: 10.1080/09593985.2026.2706161. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Wieczorek, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education and Conventional education in people with Chronic Low-back Pain, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability level (Rolland Morris questionnaire). (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179708, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.