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

Low Back Pain Clinical Trial

— NGUYEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007302
• Other study ID #: LOCAL 2017/DMNG-01
• Secondary ID: 2017-A02958-45
• Status: Completed
• Phase: N/A
• Start date: September 9, 2018
• Est. completion date: November 3, 2018

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 3, 2018
• Est. primary completion date: November 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
• completion of questionnaires
igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale
• completion of questionnaires for pain
analogical visual and numerical scale and Borg scale

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	assessment of average pain	analogical visual and numerical scale (0, no pain - 10 max pain)	Inclusion
Secondary	assessment of average pain	analogical visual and numerical scale (0, no pain - 10 max pain)	Day 1
Secondary	assessment of average pain	analogical visual and numerical scale (0, no pain - 10 max pain)	Day 2
Secondary	measurement of the distance travelled	meters	Inclusion
Secondary	measurement of the distance travelled	meters	Day 1
Secondary	measurement of the distance travelleddistraction.	meters	Day 2
Secondary	Observe a decrease in perceived effort with virtual reality distraction.	Borg's scale (0-10)	Inclusion
Secondary	measurement of perceived effort	Borg's scale (0-10)	Day 1
Secondary	measurement of perceived effort	Borg's scale (0-10)	Day 2
Secondary	measurement of perceived effort	IPQ questionary (-3 ; +3)	Day 1
Secondary	Quantify patients' adherence (presence) to the virtual environment	IPQ questionary (-3 ; +3)	Day 2