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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)
completion of questionnaires
completion of questionnaires for pain
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

walking with distraction

Walking without distraction

Arm Description

the patient walks in front of a screen with virtual reality simulation

the patient walks on a treadmill without virtual reality simulation

Outcomes

Primary Outcome Measures

measurement of prefrontal cortex activity
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
measurement of prefrontal cortex activity
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)

Secondary Outcome Measures

assessment of average pain
analogical visual and numerical scale (0, no pain - 10 max pain)
assessment of average pain
analogical visual and numerical scale (0, no pain - 10 max pain)
assessment of average pain
analogical visual and numerical scale (0, no pain - 10 max pain)
measurement of the distance travelled
meters
measurement of the distance travelled
meters
measurement of the distance travelleddistraction.
meters
Observe a decrease in perceived effort with virtual reality distraction.
Borg's scale (0-10)
measurement of perceived effort
Borg's scale (0-10)
measurement of perceived effort
Borg's scale (0-10)
measurement of perceived effort
IPQ questionary (-3 ; +3)
Quantify patients' adherence (presence) to the virtual environment
IPQ questionary (-3 ; +3)

Full Information

First Posted
July 1, 2019
Last Updated
July 3, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT04007302
Brief Title
Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago
Acronym
NGUYEN
Official Title
Modification de l'activité du Cortex préfrontal Induite Par Distraction en réalité Virtuelle Chez le Sujet Lombalgique Chronique.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 9, 2018 (Actual)
Primary Completion Date
November 3, 2018 (Actual)
Study Completion Date
November 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
walking with distraction
Arm Type
Experimental
Arm Description
the patient walks in front of a screen with virtual reality simulation
Arm Title
Walking without distraction
Arm Type
Active Comparator
Arm Description
the patient walks on a treadmill without virtual reality simulation
Intervention Type
Other
Intervention Name(s)
measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)
Intervention Description
measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method
Intervention Type
Other
Intervention Name(s)
completion of questionnaires
Intervention Description
igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale
Intervention Type
Other
Intervention Name(s)
completion of questionnaires for pain
Intervention Description
analogical visual and numerical scale and Borg scale
Primary Outcome Measure Information:
Title
measurement of prefrontal cortex activity
Description
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
Time Frame
Day 1
Title
measurement of prefrontal cortex activity
Description
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
assessment of average pain
Description
analogical visual and numerical scale (0, no pain - 10 max pain)
Time Frame
Inclusion
Title
assessment of average pain
Description
analogical visual and numerical scale (0, no pain - 10 max pain)
Time Frame
Day 1
Title
assessment of average pain
Description
analogical visual and numerical scale (0, no pain - 10 max pain)
Time Frame
Day 2
Title
measurement of the distance travelled
Description
meters
Time Frame
Inclusion
Title
measurement of the distance travelled
Description
meters
Time Frame
Day 1
Title
measurement of the distance travelleddistraction.
Description
meters
Time Frame
Day 2
Title
Observe a decrease in perceived effort with virtual reality distraction.
Description
Borg's scale (0-10)
Time Frame
Inclusion
Title
measurement of perceived effort
Description
Borg's scale (0-10)
Time Frame
Day 1
Title
measurement of perceived effort
Description
Borg's scale (0-10)
Time Frame
Day 2
Title
measurement of perceived effort
Description
IPQ questionary (-3 ; +3)
Time Frame
Day 1
Title
Quantify patients' adherence (presence) to the virtual environment
Description
IPQ questionary (-3 ; +3)
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anissa MEGZARI
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30129
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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