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

Chronic Low-back Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179708
• Other study ID #: 2018_79
• Secondary ID: 2019-A01260-57
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: June 2024

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Valérie Wieczorek, MD,PhD
• Phone: 0320445962
• Email: valerie.wieczorek[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Pain Neuroscience Education
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
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).

Locations

Country	Name	City	State
France	Hop Swynghedauw	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Société Française de Physiothérapie (SFP).

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional disability level (Rolland Morris questionnaire).		At 3 months
Secondary	Pain rating (Numeric scale)		at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Secondary	Functional disability level (Rolland Morris questionnaire)		at baseline (pre intervention), at 5 days (post intervention) and at 1 year
Secondary	Functional disability level (Dallas questionnaire)		at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Secondary	Negatives believes level (Fear Avoidance and Belief Questionnaire)		at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Secondary	Catastrophism level (Pain Catastrophizing Questionnaire)		at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Secondary	Kinesiophobia level (Tampa Scale of Kinesiophobia)		at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Secondary	Anxiety and Depression level (Hospital Anxiety and Depression scale)		at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year
Secondary	Satisfaction level (18-item of Patient Satisfaction Questionnaire)		At one year
Secondary	semi-conductive interview		At 3 months