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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
82
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
Self and hetero assessments measuring pain, different determinants of chronic pain and physical activity
Hospital Center Paul Coste Floret
Lamalou-les-Bains, France
RECRUITINGNumber 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
Time frame: 3 months after rehabilitation program
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)
Time frame: between baseline and 3 months
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)
Time frame: between 3 months and 12 months
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
Time frame: 12 months after rehabilitation program
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)
Time frame: 3 months after rehabilitation program
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)
Time frame: 12 months after rehabilitation program
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)
Time frame: between baseline and 3 months
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)
Time frame: between 3 and 12 months
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
Time frame: 3 months after rehabilitation program
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
Time frame: 12 months after rehabilitation program
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
Time frame: between baseline and 3 months
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
Time frame: between 3 and 12 months
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.
Time frame: 3 months after rehabilitation program
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.
Time frame: 12 months after rehabilitation program
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.
Time frame: between baseline and 3 months
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.
Time frame: between 3 and 12 months
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
Time frame: 3 months after rehabilitation program
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
Time frame: 12 months after rehabilitation program
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
Time frame: between baseline and 3 months
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
Time frame: between 3 and 12 months
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
Time frame: 3 months after rehabilitation program
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
Time frame: 12 months after rehabilitation program
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.
Time frame: between baseline and 3 months
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.
Time frame: between 3 and 12 months
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
Time frame: 3 months after rehabilitation program
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
Time frame: 12 months after rehabilitation program
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
Time frame: between baseline and 3 months
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
Time frame: between 3 and 12 months
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.
Time frame: 3 months after rehabilitation program
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.
Time frame: 12 months after rehabilitation program
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.
Time frame: between baseline and 3 months
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.
Time frame: between baseline and 12 months
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
Time frame: 3 months after rehabilitation program
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
Time frame: 12 months after rehabilitation program
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
Time frame: between baseline and 3 months after rehabilitation
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
Time frame: between 3 and 12 months after rehabilitation program
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