Clinical trial NCT04179708: Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain
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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Therapeutic Patient Education
Chronic Low Back Pain
Chronic Pain
Pain Neuroscience Education
Pain Neurophysiology Education
Pain biology education
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Société Française de Physiothérapie (SFP).
First posted: 2019-11-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Functional disability level (Rolland Morris questionnaire).
timeFrame: At 3 months
Secondary outcomes:
measure: Pain rating (Numeric scale)
timeFrame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
measure: Functional disability level (Rolland Morris questionnaire)
timeFrame: at baseline (pre intervention), at 5 days (post intervention) and at 1 year
measure: Functional disability level (Dallas questionnaire)
timeFrame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
measure: Negatives believes level (Fear Avoidance and Belief Questionnaire)
timeFrame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
measure: Catastrophism level (Pain Catastrophizing Questionnaire)
timeFrame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
measure: Kinesiophobia level (Tampa Scale of Kinesiophobia)
timeFrame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
measure: Anxiety and Depression level (Hospital Anxiety and Depression scale)
timeFrame: at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
measure: Satisfaction level (18-item of Patient Satisfaction Questionnaire)
timeFrame: At one year
measure: semi-conductive interview
timeFrame: At 3 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Swynghedauw
Study officials:
affiliation: University Hospital, Lille
name: Valérie Wieczorek, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: