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Effectiveness of a Pain Neuroscience Education Programme on Physical Activity in Patients With Chronic Low Back Pain (END-LC)

Primary Purpose

Low Back Pain, Recurrent

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Activity monitor
Questionnaire
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain, Recurrent focused on measuring Low back pain, Pain Neurosciences Education, Physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital Center Paul Coste FloretRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain Neuroscience Education

Back School

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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
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)
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)
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)
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)
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
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
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
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
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.
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.
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.
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.
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
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
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
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
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
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
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.
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.
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
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
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
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
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.
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.
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.
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.
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
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
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
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

Full Information

First Posted
April 21, 2023
Last Updated
October 13, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05840302
Brief Title
Effectiveness of a Pain Neuroscience Education Programme on Physical Activity in Patients With Chronic Low Back Pain
Acronym
END-LC
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent
Keywords
Low back pain, Pain Neurosciences Education, Physical activity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Neuroscience Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Back School
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Activity monitor
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Self and hetero assessments measuring pain, different determinants of chronic pain and physical activity
Primary Outcome Measure Information:
Title
Number of Steps 3 months after rehabilitation program
Description
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
Secondary Outcome Measure Information:
Title
Changes in Number of Steps 3 months after rehabilitation program
Description
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
Title
Changes in Number of Steps 12 months after rehabilitation program
Description
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
Title
Number of Steps 12 months after rehabilitation program
Description
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
Title
Pain intensity 3 months after rehabilitation program
Description
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
Title
Pain intensity 12 months after rehabilitation program
Description
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
Title
Changes in pain intensity 3 months after rehabilitation program
Description
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
Title
Changes in pain intensity 12 months after rehabilitation program
Description
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
Title
Central Sensitivity score 3 months after rehabilitation program
Description
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
Title
Central Sensitivity score 12 months after rehabilitation program
Description
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
Title
Changes in Central Sensitivity score 3 months after rehabilitation program
Description
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
Title
Changes in Central Sensitivity score 12 months after rehabilitation program
Description
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
Title
Pain Catastrophizing score 3 months after rehabilitation program
Description
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
Title
Pain Catastrophizing score 12 months after rehabilitation program
Description
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
Title
Changes in Pain Catastrophizing score 3 months after rehabilitation program
Description
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
Title
Changes in Pain Catastrophizing score 12 months after rehabilitation program
Description
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
Title
Kinesiophobia scale score 3 months after rehabilitation program
Description
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
Title
Kinesiophobia scale score 12 months after rehabilitation program
Description
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
Title
Changes in Kinesiophobia scale score 3 months after rehabilitation program
Description
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
Title
Changes in Kinesiophobia scale score 12 months after rehabilitation program
Description
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
Title
Canadian Occupational Performance Measure 3 months after rehabilitation program
Description
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
Title
Canadian Occupational Performance Measure 12 months after rehabilitation program
Description
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
Title
Changes in Canadian Occupational Performance Measure 3 months after rehabilitation program
Description
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
Title
Changes in Canadian Occupational Performance Measure 12 months after rehabilitation program
Description
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
Title
Global Physical Activity score 3 months after rehabilitation program
Description
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
Title
Global Physical Activity score 12 months after rehabilitation program
Description
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
Title
Changes in the global Physical Activity score 3 months after rehabilitation program
Description
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
Title
Changes in the global Physical Activity score 12 months after rehabilitation program
Description
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
Title
Hospital Anxiety and Depression score 3 months after rehabilitation program
Description
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
Title
Hospital Anxiety and Depression score 12 months after rehabilitation program
Description
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
Title
Changes in Hospital Anxiety and Depression score 3 months after rehabilitation program
Description
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
Title
Changes in Hospital Anxiety and Depression score 12 months after rehabilitation program
Description
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
Title
Quality of Life Score 3 months after rehabilitation program
Description
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
Title
Quality of Life Score 12 months after rehabilitation program
Description
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
Title
Changes in the Quality of Life Score 3 months after rehabilitation program
Description
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
Title
Changes in the Quality of Life Score 12 months after rehabilitation program
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaël LE PERF
Phone
0467235729
Ext
+33
Email
gael.leperf@hopital-lamalou.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume THEBAULT
Phone
0467235511
Ext
+33
Email
guillaume.thebault@hopital-lamalou.fr
Facility Information:
Facility Name
Hospital Center Paul Coste Floret
City
Lamalou-Les-Bains
ZIP/Postal Code
34240
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaël LE PERF
Phone
0467235729
Email
gael.leperf@hopital-lamalou.fr
First Name & Middle Initial & Last Name & Degree
Guillaume THEBAULT
Phone
0467235511
Email
guillaume.thebault@hopital-lamalou.fr

12. IPD Sharing Statement

Learn more about this trial

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

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