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

Low Back Pain, Recurrent Clinical Trial

— END-LC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840302
• Other study ID #: 21_0513
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: September 2027

Study information

• Verified date: October 2023
• Source: University Hospital, Montpellier
• Contact: Gaël LE PERF
• Phone: 0467235729
• Email: gael.leperf[@]hopital-lamalou.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

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

Locations

Country	Name	City	State
France	Hospital Center Paul Coste Floret	Lamalou-Les-Bains

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Number of Steps 3 months after rehabilitation program	Changes in the average number of daily steps calculated over 7 days by an activity monitor (connected watch) named Actigraph wGT3X-BT at two different times (before and 3 months after rehabilitation program)	between baseline and 3 months
Secondary	Changes in Number of Steps 12 months after rehabilitation program	Changes in the average number of daily steps calculated over 7 days by an activity monitor (connected watch) named Actigraph wGT3X-BT at two different times (3 and 12 months after rehabilitation program)	between 3 months and 12 months
Secondary	Number of Steps 12 months after rehabilitation program	Comparison between the two arms of the average number of daily steps calculated over 7 days by an an activity monitor (connected watch) named Actigraph wGT3X-BT	12 months after rehabilitation program
Secondary	Pain intensity 3 months after rehabilitation program	Comparison between the two arms of the pain intensity. Pain intensity score will evaluated using a Pain Numerical Rating Scale (NRS) A high score indicates severe pain (0 = absence of pain, 10 = severe pain)	3 months after rehabilitation program
Secondary	Pain intensity 12 months after rehabilitation program	Comparison between the two arms of the pain intensity. Pain intensity score will evaluated using a Pain Numerical Rating Scale (NRS) A high score indicates severe pain (0 = absence of pain, 10 = severe pain)	12 months after rehabilitation program
Secondary	Changes in pain intensity 3 months after rehabilitation program	Changes in pain intensity at two different times (before and 3 months after rehabilitation program) Pain intensity score will evaluated using a Pain Numerical Rating Scale (NRS) A high score indicates severe pain (0 = absence of pain, 10 = severe pain)	between baseline and 3 months
Secondary	Changes in pain intensity 12 months after rehabilitation program	Changes in pain intensity at two different times (before and 3 months after rehabilitation program) Pain intensity score will evaluated using a Pain Numerical Rating Scale (NRS) A high score indicates severe pain (0 = absence of pain, 10 = severe pain)	between 3 and 12 months
Secondary	Central Sensitivity score 3 months after rehabilitation program	Comparison between the two arms of the Central Sensitivity score Central Sensitivity score will evaluate with The Central Sensitization Inventory that is a valid screening tool to identify and quantify central sensitization to pain	3 months after rehabilitation program
Secondary	Central Sensitivity score 12 months after rehabilitation program	Comparison between the two arms of the Central Sensitivity score Central Sensitivity score will evaluate with The Central Sensitization Inventory that is a valid screening tool to identify and quantify central sensitization to pain	12 months after rehabilitation program
Secondary	Changes in Central Sensitivity score 3 months after rehabilitation program	Changes in Central Sensitivity score at two different times (before and 3 months after rehabilitation program). Central Sensitivity score will evaluate with The Central Sensitization Inventory that is a valid screening tool to identify and quantify central sensitization to pain	between baseline and 3 months
Secondary	Changes in Central Sensitivity score 12 months after rehabilitation program	Changes in pain intensity at two different times (3 and 12 months after rehabilitation program). Central Sensitivity score will evaluate with The Central Sensitization Inventory that is a valid screening tool to identify and quantify central sensitization to pain	between 3 and 12 months
Secondary	Pain Catastrophizing score 3 months after rehabilitation program	Comparison between the two arms of the Pain Catastrophizing score. The Pain Catastrophizing Scale is a questionnaire of 13 statements rated by a five-point ordinal scale, measuring a subject's level of pain catastrophizing.	3 months after rehabilitation program
Secondary	Pain Catastrophizing score 12 months after rehabilitation program	Comparison between the two arms of the Pain Catastrophizing score. The Pain Catastrophizing Scale is a questionnaire of 13 statements rated by a five-point ordinal scale, measuring a subject's level of pain catastrophizing.	12 months after rehabilitation program
Secondary	Changes in Pain Catastrophizing score 3 months after rehabilitation program	Changes in the Pain Catastrophizing score at two different times (baseline and 3 months after rehabilitation program) The Pain Catastrophizing Scale is a questionnaire of 13 statements rated by a five-point ordinal scale, measuring a subject's level of pain catastrophizing.	between baseline and 3 months
Secondary	Changes in Pain Catastrophizing score 12 months after rehabilitation program	Changes in the Pain Catastrophizing score at two different times (3 and 12 months after rehabilitation program) The Pain Catastrophizing Scale is a questionnaire of 13 statements rated by a five-point ordinal scale, measuring a subject's level of pain catastrophizing.	between 3 and 12 months
Secondary	Kinesiophobia scale score 3 months after rehabilitation program	Comparison between the two arms of the Kinesiophobia scale score Kinesiophobia scale score will evaluate using the Tampa Scale of Kinesiophobia. The Tampa Scale of Kinesiophobia is a questionnaire of 17 questions rated by a four-point ordinal scale, measuring the fear that pain may occur as a result of movement. These fears can lead to avoidance behaviors and reduced activity	3 months after rehabilitation program
Secondary	Kinesiophobia scale score 12 months after rehabilitation program	Comparison between the two arms of the Kinesiophobia scale score Kinesiophobia scale score will evaluate using the Tampa Scale of Kinesiophobia. The Tampa Scale of Kinesiophobia is a questionnaire of 17 questions rated by a four-point ordinal scale, measuring the fear that pain may occur as a result of movement. These fears can lead to avoidance behaviors and reduced activity	12 months after rehabilitation program
Secondary	Changes in Kinesiophobia scale score 3 months after rehabilitation program	Changes in the Pain Catastrophizing score at two different times (baseline and 3 months after rehabilitation program) Kinesiophobia scale score will evaluate using the Tampa Scale of Kinesiophobia. The Tampa Scale of Kinesiophobia is a questionnaire of 17 questions rated by a four-point ordinal scale, measuring the fear that pain may occur as a result of movement. These fears can lead to avoidance behaviors and reduced activity	between baseline and 3 months
Secondary	Changes in Kinesiophobia scale score 12 months after rehabilitation program	Changes in the Pain Catastrophizing score at two different times (3 and 12 months after rehabilitation program) Kinesiophobia scale score will evaluate using the Tampa Scale of Kinesiophobia. The Tampa Scale of Kinesiophobia is a questionnaire of 17 questions rated by a four-point ordinal scale, measuring the fear that pain may occur as a result of movement. These fears can lead to avoidance behaviors and reduced activity	between 3 and 12 months
Secondary	Canadian Occupational Performance Measure 3 months after rehabilitation program	Comparison between the two arms of Canadian Occupational Performance Measure The Canadian Occupational Performance Measure assess changes in occupational during a semi-structured interview performance	3 months after rehabilitation program
Secondary	Canadian Occupational Performance Measure 12 months after rehabilitation program	Comparison between the two arms of Canadian Occupational Performance Measure The Canadian Occupational Performance Measure assess changes in occupational during a semi-structured interview performance	12 months after rehabilitation program
Secondary	Changes in Canadian Occupational Performance Measure 3 months after rehabilitation program	Changes in the Pain Catastrophizing score at two different times (baseline and 3 months after rehabilitation program). The Canadian Occupational Performance Measure assess changes in occupational during a semi-structured interview performance.	between baseline and 3 months
Secondary	Changes in Canadian Occupational Performance Measure 12 months after rehabilitation program	Changes in the Pain Catastrophizing score at two different times (3 and 12 months after rehabilitation program). The Canadian Occupational Performance Measure assess changes in occupational during a semi-structured interview performance.	between 3 and 12 months
Secondary	Global Physical Activity score 3 months after rehabilitation program	Comparison between the two arms of the Global Physical Activity score. Global Physical Activity score will evaluate using the Global Physical Activity Questionnaire.; The Global Physical Activity Questionnaire consists of 16 questions designed to estimate an individual's level of physical activity in 3 domains (work, transport and leisure time) and time spent in sedentary behavior	3 months after rehabilitation program
Secondary	Global Physical Activity score 12 months after rehabilitation program	Comparison between the two arms of the Global Physical Activity score. Global Physical Activity score will evaluate using the Global Physical Activity Questionnaire.; The Global Physical Activity Questionnaire consists of 16 questions designed to estimate an individual's level of physical activity in 3 domains (work, transport and leisure time) and time spent in sedentary behavior	12 months after rehabilitation program
Secondary	Changes in the global Physical Activity score 3 months after rehabilitation program	Changes in the global Physical Activity score at two different times (baseline and 3 months after rehabilitation program). Global Physical Activity score will evaluate using the Global Physical Activity Questionnaire.; The Global Physical Activity Questionnaire consists of 16 questions designed to estimate an individual's level of physical activity in 3 domains (work, transport and leisure time) and time spent in sedentary behavior	between baseline and 3 months
Secondary	Changes in the global Physical Activity score 12 months after rehabilitation program	Changes in the global Physical Activity score at two different times (3 and 12 months after rehabilitation program). Global Physical Activity score will evaluate using the Global Physical Activity Questionnaire.; The Global Physical Activity Questionnaire consists of 16 questions designed to estimate an individual's level of physical activity in 3 domains (work, transport and leisure time) and time spent in sedentary behavior	between 3 and 12 months
Secondary	Hospital Anxiety and Depression score 3 months after rehabilitation program	Comparison between the two arms of the Hospital Anxiety and Depression score Hospital Anxiety and Depression score will evaluate using Hospital Anxiety and Depression scale.; The Hospital Anxiety and Depression Scale consists of 7 items designed to evaluate depression and 7 for the anxiety.	3 months after rehabilitation program
Secondary	Hospital Anxiety and Depression score 12 months after rehabilitation program	Comparison between the two arms of the Hospital Anxiety and Depression score Hospital Anxiety and Depression score will evaluate using Hospital Anxiety and Depression scale.; The Hospital Anxiety and Depression Scale consists of 7 items designed to evaluate depression and 7 for the anxiety.	12 months after rehabilitation program
Secondary	Changes in Hospital Anxiety and Depression score 3 months after rehabilitation program	Changes in Hospital Anxiety and Depression score at two different times (baseline and 3 months after rehabilitation program).; Hospital Anxiety and Depression score will evaluate using Hospital Anxiety and Depression scale.; The Hospital Anxiety and Depression Scale consists of 7 items designed to evaluate depression and 7 for the anxiety.	between baseline and 3 months
Secondary	Changes in Hospital Anxiety and Depression score 12 months after rehabilitation program	Changes in Hospital Anxiety and Depression score at two different times (3 and 12 months after rehabilitation program).; Hospital Anxiety and Depression score will evaluate using Hospital Anxiety and Depression scale.; The Hospital Anxiety and Depression Scale consists of 7 items designed to evaluate depression and 7 for the anxiety.	between baseline and 12 months
Secondary	Quality of Life Score 3 months after rehabilitation program	Comparison between the two arms of the Quality of Life Score The Quality of Life Score will evaluate with the Short Form (36) Health Survey questionnaire that is multidimensional assessment of quality of life	3 months after rehabilitation program
Secondary	Quality of Life Score 12 months after rehabilitation program	Comparison between the two arms of the Quality of Life Score The Quality of Life Score will evaluate with the Short Form (36) Health Survey questionnaire that is multidimensional assessment of quality of life	12 months after rehabilitation program
Secondary	Changes in the Quality of Life Score 3 months after rehabilitation program	Changes in Quality of Life Score at two different times (baseline and 3 months after rehabilitation program).; The Quality of Life Score will evaluate with the Short Form (36) Health Survey questionnaire that is multidimensional assessment of quality of life	between baseline and 3 months after rehabilitation
Secondary	Changes in the Quality of Life Score 12 months after rehabilitation program	Changes in Quality of Life Score at two different times (3 and 12 months after rehabilitation program). The Quality of Life Score will evaluate with the Short Form (36) Health Survey questionnaire that is multidimensional assessment of quality of life	between 3 and 12 months after rehabilitation program