Clinical trial NCT05840302: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Recurrent
Keywords: Low back pain
Pain Neurosciences Education
Physical activity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Number of Steps 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
Secondary outcomes:
measure: Changes in Number of Steps 3 months after rehabilitation program
timeFrame: between baseline and 3 months
measure: Changes in Number of Steps 12 months after rehabilitation program
timeFrame: between 3 months and 12 months
measure: Number of Steps 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Pain intensity 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
measure: Pain intensity 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Changes in pain intensity 3 months after rehabilitation program
timeFrame: between baseline and 3 months
measure: Changes in pain intensity 12 months after rehabilitation program
timeFrame: between 3 and 12 months
measure: Central Sensitivity score 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
measure: Central Sensitivity score 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Changes in Central Sensitivity score 3 months after rehabilitation program
timeFrame: between baseline and 3 months
measure: Changes in Central Sensitivity score 12 months after rehabilitation program
timeFrame: between 3 and 12 months
measure: Pain Catastrophizing score 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
measure: Pain Catastrophizing score 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Changes in Pain Catastrophizing score 3 months after rehabilitation program
timeFrame: between baseline and 3 months
measure: Changes in Pain Catastrophizing score 12 months after rehabilitation program
timeFrame: between 3 and 12 months
measure: Kinesiophobia scale score 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
measure: Kinesiophobia scale score 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Changes in Kinesiophobia scale score 3 months after rehabilitation program
timeFrame: between baseline and 3 months
measure: Changes in Kinesiophobia scale score 12 months after rehabilitation program
timeFrame: between 3 and 12 months
measure: Canadian Occupational Performance Measure 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
measure: Canadian Occupational Performance Measure 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Changes in Canadian Occupational Performance Measure 3 months after rehabilitation program
timeFrame: between baseline and 3 months
measure: Changes in Canadian Occupational Performance Measure 12 months after rehabilitation program
timeFrame: between 3 and 12 months
measure: Global Physical Activity score 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
measure: Global Physical Activity score 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Changes in the global Physical Activity score 3 months after rehabilitation program
timeFrame: between baseline and 3 months
measure: Changes in the global Physical Activity score 12 months after rehabilitation program
timeFrame: between 3 and 12 months
measure: Hospital Anxiety and Depression score 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
measure: Hospital Anxiety and Depression score 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Changes in Hospital Anxiety and Depression score 3 months after rehabilitation program
timeFrame: between baseline and 3 months
measure: Changes in Hospital Anxiety and Depression score 12 months after rehabilitation program
timeFrame: between baseline and 12 months
measure: Quality of Life Score 3 months after rehabilitation program
timeFrame: 3 months after rehabilitation program
measure: Quality of Life Score 12 months after rehabilitation program
timeFrame: 12 months after rehabilitation program
measure: Changes in the Quality of Life Score 3 months after rehabilitation program
timeFrame: between baseline and 3 months after rehabilitation
measure: Changes in the Quality of Life Score 12 months after rehabilitation program
timeFrame: between 3 and 12 months after rehabilitation program
Other outcomes:
Locations:
city: Lamalou-Les-Bains
country: France
facility: Hospital Center Paul Coste Floret
Study officials:
References: