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

NCT04007302 | Completed

• 2 other identifiers: LOCAL 2017/DMNG-012017-A02958-45
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• assessment of average pain

  Inclusion

• assessment of average pain

  Day 1

• assessment of average pain

  Day 2

• measurement of the distance travelled

  Inclusion

• measurement of the distance travelled

  Day 1

Study Arms (2)

walking with distraction

EXPERIMENTAL

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); Other: completion of questionnaires; Other: completion of questionnaires for pain

Walking without distraction

ACTIVE COMPARATOR

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); Other: completion of questionnaires; Other: completion of questionnaires for pain

Interventions

measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy) OTHER

measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method

Walking without distraction; walking with distraction

completion of questionnaires OTHER

igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale

Walking without distraction; walking with distraction

completion of questionnaires for pain OTHER

analogical visual and numerical scale and Borg scale

Walking without distraction; walking with distraction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject participates in another intervention 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30129, France

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Anissa MEGZARI

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: September 9, 2018
• Primary Completion: November 3, 2018
• Study Completion: November 3, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)