Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago (NGUYEN)

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy); Other: completion of questionnaires; Other: completion of questionnaires for pain

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30129
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient must have given free and informed consent and signed the consent
• The patient must be a member or beneficiary of a health insurance plan
• The patient is available for a 3-day follow-up
• The patient is between 18 and 75 years old
• Disabling lumbar pain beyond three months

Exclusion Criteria:

• Subject participates in another intervention study
• Subject is in an exclusion period determined by a previous study
• The subject is under the protection of justice, guardianship or curatorship
• Subject refuses to sign consent
• It is impossible to provide informed information about the subject
• The subject is unable to complete the study questionnaires
• The patient is pregnant, parturient, or breastfeeding
• The subject has a contraindication (or incompatible drug combination) for a treatment required for this study
• Recent involuntary weight loss
• Inflammatory schedule pain (predominantly nocturnal, requiring early morning rusting, improved by physical activity)
• Associated fever,
• Saddle anaesthesia
• Vesico-sphincterial disorders
• Typical root symptoms
• Systemic corticosteroid therapy
• History of cancer
• History of spinal trauma
• History of intravenous drug use
• Systemic corticosteroid therapy
• Surgical intervention of the spine or lower limbs
• Painful pathology of the lower limbs (coxarthrosis, gonarthrosis, vascular claudication or neurogenic when walking).

Exclusion criteria:

● Taking prescribed analgesic treatment after the inclusion procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: walking with distraction; the patient walks in front of a screen with virtual reality simulation	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
Active Comparator: Walking without distraction; the patient walks on a treadmill without virtual reality simulation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2018
• Primary Completion (Actual): November 3, 2018
• Study Completion (Actual): November 3, 2018

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LOCAL 2017/DMNG-01; 2017-A02958-45 (Other Identifier: ANSM, France)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No