Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT04007302
Brief 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.
Study:
NCT04007302
Study Brief:
Protocol Section:
NCT04007302