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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02958-45 | Other Identifier | ANSM, France |
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The hypothesis of this work is that distraction is an effective way to modify the feeling and experience of chronic lumbar pain by modifying the functioning of the prefrontal cortex.
The main objective of this study is to show that during chronic low back pain generated during physical exercise, virtual reality distraction leads to the modification of the activity of the prefrontal cortex.
The secondary objectives are:
A pre-test phase at D0 will be carried out with the objective of individually determining the exercise conditions (speed and slope) of walking that will generate lumbar pain. Patients who have not experienced lumbar pain during this phase will be excluded from the study. The patients included are then randomized according to the order of physical exercise situations.
For the tests, patients will be equipped with a miniaturized wireless (Octamon, Artinis) and multi-channel (8 optodes) NIRS device placed on the patient's frontal lobe according to EEG 10-20 positioning (fig. 2). They will then be placed on an inclined treadmill according to the angle that caused the pain during the pre-test.
During the test, subjects will walk to the voluntary stop and the different reasons for the stop (feeling of fatigue, pain, etc.) will be recorded by visual analogue scales and questionnaires. The duration of the exercise will be measured by a digital stopwatch connected to the treadmill. During physical exercise, the bilateral activity of the prefrontal cortex will be recorded continuously at a sampling frequency of 10 Hz.
For each test, subjects will be confronted with 2 situations, on D1 and D2. In a situation, walking will be done without distraction. In the other situation, the patient will be placed in front of a screen with virtual reality simulation while performing the walking exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| walking with distraction | Experimental | the patient walks in front of a screen with virtual reality simulation |
|
| Walking without distraction | Active Comparator | the patient walks on a treadmill without virtual reality simulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy) | Other | measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method |
| Measure | Description | Time Frame |
|---|---|---|
| measurement of prefrontal cortex activity | Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm) | Day 1 |
| measurement of prefrontal cortex activity | Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm) | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of average pain | analogical visual and numerical scale (0, no pain - 10 max pain) | Inclusion |
| assessment of average pain | analogical visual and numerical scale (0, no pain - 10 max pain) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria:
● Taking prescribed analgesic treatment after the inclusion procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Anissa MEGZARI | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes | Nîmes | 30129 | France |
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| completion of questionnaires | Other | igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale |
|
| completion of questionnaires for pain | Other | analogical visual and numerical scale and Borg scale |
|
| Day 1 |
| assessment of average pain | analogical visual and numerical scale (0, no pain - 10 max pain) | Day 2 |
| measurement of the distance travelled | meters | Inclusion |
| measurement of the distance travelled | meters | Day 1 |
| measurement of the distance travelleddistraction. | meters | Day 2 |
| Observe a decrease in perceived effort with virtual reality distraction. | Borg's scale (0-10) | Inclusion |
| measurement of perceived effort | Borg's scale (0-10) | Day 1 |
| measurement of perceived effort | Borg's scale (0-10) | Day 2 |
| measurement of perceived effort | IPQ questionary (-3 ; +3) | Day 1 |
| Quantify patients' adherence (presence) to the virtual environment | IPQ questionary (-3 ; +3) | Day 2 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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