CHU de Nîmes
Nîmes, 30129, France
NCT Number: NCT04007302
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:
* Show a significant decrease in the average pain assessed with EVA during physical exercise with virtual reality distraction. * Show an increase in the distance travelled with virtual reality distraction. * Observe a decrease in perceived effort with virtual reality distraction. * Quantify the adherence (presence) of subjects to the virtual environment
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Nîmes, 30129, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
● Taking prescribed analgesic treatment after the inclusion procedure.
measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method
igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale
analogical visual and numerical scale and Borg scale
Time frame: Day 1
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
Time frame: Day 2
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
Time frame: Inclusion
analogical visual and numerical scale (0, no pain - 10 max pain)
Time frame: Day 1
analogical visual and numerical scale (0, no pain - 10 max pain)
Time frame: Day 2
analogical visual and numerical scale (0, no pain - 10 max pain)
Time frame: Inclusion
meters
Time frame: Day 1
meters
Time frame: Day 2
meters
Time frame: Inclusion
Borg's scale (0-10)
Time frame: Day 1
Borg's scale (0-10)
Time frame: Day 2
Borg's scale (0-10)
Time frame: Day 1
IPQ questionary (-3 ; +3)
Time frame: Day 2
IPQ questionary (-3 ; +3)
Centre Hospitalier Universitaire de Nīmes
Other
Modification de l'activité du Cortex préfrontal Induite Par Distraction en réalité Virtuelle Chez le Sujet Lombalgique Chronique.
Acronym: NGUYEN
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