NCT04007302

Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago

Modification de l'activité du Cortex préfrontal Induite Par Distraction en réalité Virtuelle Chez le Sujet Lombalgique Chronique.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)	measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method
OTHER	completion of questionnaires	igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale
OTHER	completion of questionnaires for pain	analogical visual and numerical scale and Borg scale

Timeline

• Start date: 2018-09-09
• Primary completion: 2018-11-03
• Completion: 2018-11-03
• First posted: 2019-07-05
• Last updated: 2019-07-08

Locations

1 site across 1 country: France