Effectiveness of a Pain Neuroscience Education Programme on Physical Activity in Patients With Chronic Low Back Pain

NCT05840302 | Recruiting

• 2 other identifiers: RECHMPL21_0513ID-RCB
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Proposing ways to effectively counter chronic low back pain through non-drug intervention is a major public health issue due to the prevalence and health costs of this condition. The back school (BS) is based on spinal economics and a biomechanical model. A convergence of evidence indicates that this type of program does not bring any mid- or long-term benefit. Faced with this observation, a Pain Neuroscience Education (PNE) has been developed based on a biopsychosocial model. Chronic low back pain is the consequence of a complex dynamic of multifactorial origin where the body lesion is no longer the only cause of the pain. Studies have shown that PNE has a positive effect on pain perception. One of the limitations of these studies is that they do not allow objective measurement of physical activity performed at a distance from a therapeutic program for patients who have benefited from these educational programs. Yet, physical activity is an essential variable in health and more specifically in the fight against pain in patients with chronic low back pain. The investigators believe that physical activity is a key factor in improving the condition of patients with chronic low back pain. Consequently, physical activity is an indicator of success but also a guarantee for a lasting effect of educational treatment. In order to measure this physical activity, the use of activity monitor (connected watch) developed in recent years now makes it possible to collect data in an ecological manner that is more objective than the data collected via self-questionnaires. The main objective of the study is to measure the effectiveness of a PNE on physical activity three months after the intervention compared to BS in patients with chronic low back pain receiving a multidisciplinary rehabilitation program. The secondary aims are to compare effectiveness of PNE versus BS on pain, quality of life, kinesiophobia, pain catastrophizing, central sensitization at 3 months and at one year after the intervention. In addition, an exploratory analysis will be conducted to determine predictors of physical activity maintenance. The investigators expect to observe greater physical activity in patients who have received a PNE program compared to the physical activity of patients who have completed an BS program.

Conditions

Low Back Pain, Recurrent

Keywords

Low back pain; Pain Neurosciences Education; Physical activity

Outcome Measures

Primary Outcomes (1)

• Number of Steps 3 months after rehabilitation program

  Comparison between the two arms of the average number of daily steps calculated over 7 days by an activity monitor (connected watch) named Actigraph wGT3X-BT

  3 months after rehabilitation program

Secondary Outcomes (35)

• Changes in Number of Steps 3 months after rehabilitation program

  between baseline and 3 months

• Changes in Number of Steps 12 months after rehabilitation program

  between 3 months and 12 months

• Number of Steps 12 months after rehabilitation program

  12 months after rehabilitation program

• Pain intensity 3 months after rehabilitation program

  3 months after rehabilitation program

• Pain intensity 12 months after rehabilitation program

  12 months after rehabilitation program

Study Arms (2)

Pain Neuroscience Education

EXPERIMENTAL

The Pain Neuroscience Education program takes place over ten days consisting of providing knowledge about the neurophysiology and central processes of pain (nociceptive pathways, inhibitory circuits, peripheral and central sensitization, nervous system plasticity) as well as psychosocial factors and beliefs contributing to chronic pain. Workshops will use experimental data from neuroscience, but also analogies, brainstorming or games. Questions are proposed to the patient at the end of each theme.

Device: Activity monitor; Other: Questionnaire

Back School

ACTIVE COMPARATOR

The Back School program takes place over ten days. It begins with a presentation of spinal economy, which consists of promoting the protection of the back. Then, the anatomy and biomechanics of the spine as well as the most common spinal pathologies are presented. On this biomechanical basis, the other sessions consist in indicating the gestures and postures to adopt, always according to the protection policy, in different situations. These different sessions alternate between theory and practical exercises.

Device: Activity monitor; Other: Questionnaire

Interventions

Activity monitor DEVICE

Measure of number of steps and physical activity during one week using the activity monitor (connected watch) named the ActiGraph-wGT3X-BT medical device, Pre-test before intervention, post-test 3-months and 1-year after intervention

Back School; Pain Neuroscience Education

Questionnaire OTHER

Self and hetero assessments measuring pain, different determinants of chronic pain and physical activity

Back School; Pain Neuroscience Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age.
• Ordinary back pain according to the High Authority for Health criteria 2019
• Chronic back pain (\> 3months)
• Start Back Screening Tool \> 3
• Partial hospitalization at the Lamalou-les-Bains Hospital for a multidisciplinary rehabilitation program

You may not qualify if:

• Subject with a comorbidity that limits walking (e.g. central neurological disorder)
• Subject with current psychiatric or cognitive co-morbidity that does not allow educational programs to be completed
• Stay following a surgical procedure of less than three months
• Other specific low back pain treatment planned during the 3 months of follow-up (surgery, infiltration)
• Patient participating in another clinical trial related to low back pain
• Subject does not understand the French language.
• Pregnant woman, parturient or nursing
• Subject with a legal protection measure (guardianship, curators)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hospital Center Paul Coste Floret

Lamalou-les-Bains, 34240, France

RECRUITING

Related Publications (1)

• Thebault G, Duflos C, Le Perf G. Effectiveness of a pain neuroscience education programme on the physical activity of patients with chronic low back pain compared with a standard back school programme: protocol for a randomised controlled study (END-LC). BMJ Open. 2024 Jun 3;14(6):e080079. doi: 10.1136/bmjopen-2023-080079.

  PMID: 38830744 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Fitness Trackers; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Gaël LE PERF

CONTACT

0467235729; gael.leperf@hopital-lamalou.fr

Guillaume THEBAULT

CONTACT

0467235511; guillaume.thebault@hopital-lamalou.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

FR (1)