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

Official title

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

Overview

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.

Interventions

• Device Activity monitor
  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
• Other Questionnaire
  Self and hetero assessments measuring pain, different determinants of chronic pain and physical activity

Primary outcome measures

• Number of Steps 3 months after rehabilitation program [Time frame: 3 months after rehabilitation program]

Secondary outcome measures (12)

• Changes in Number of Steps 3 months after rehabilitation program [Time frame: between baseline and 3 months]
• Changes in Number of Steps 12 months after rehabilitation program [Time frame: between 3 months and 12 months]
• Number of Steps 12 months after rehabilitation program [Time frame: 12 months after rehabilitation program]
• Pain intensity 3 months after rehabilitation program [Time frame: 3 months after rehabilitation program]
• Pain intensity 12 months after rehabilitation program [Time frame: 12 months after rehabilitation program]
• Changes in pain intensity 3 months after rehabilitation program [Time frame: between baseline and 3 months]
• Changes in pain intensity 12 months after rehabilitation program [Time frame: between 3 and 12 months]
• Central Sensitivity score 3 months after rehabilitation program [Time frame: 3 months after rehabilitation program]
• Central Sensitivity score 12 months after rehabilitation program [Time frame: 12 months after rehabilitation program]
• Changes in Central Sensitivity score 3 months after rehabilitation program [Time frame: between baseline and 3 months]
• Changes in Central Sensitivity score 12 months after rehabilitation program [Time frame: between 3 and 12 months]
• Pain Catastrophizing score 3 months after rehabilitation program [Time frame: 3 months after rehabilitation program]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Hospital Center Paul Coste Floret — Lamalou-les-Bains

Publications

• 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

Identifiers

NCT: NCT05840302 · RECHMPL21_0513 · ID-RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗