Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain

Virtual reality systems have been applied in recent years to reduce pain intensity and fear of movement in individuals with acute and chronic pain. The main mechanism of virtual reality methods in pain control is to provide the effect of distraction from pain. Virtual reality systems allow the individuals to feel themselves in a different environment and shift their attention to the game they are playing or the virtual world created rather than the pain they feel. This is thought to be the main mechanism of pain control. However, the cortical mechanism of the reduction in pain caused by virtual reality methods, especially in individuals with chronic pain, has not been fully elucidated.

It is predicted that the integration of virtual reality methods into treatment protocols will gradually increase by time, especially as a result of the reflection of technological developments in clinical practice. At this point, fNIRS, which enables the assessment of the functionality of brain areas during movement, has the potential to reveal the response of the effect provided by virtual reality technology in the prefrontal cortex.

The aims of our study were to examine brain hemodynamic activity during the experience of non-immersive and immersive virtual reality environments and the change in pain intensity after virtual reality applications in individuals with rheumatic diseases with chronic pain.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Chronic Pain; Virtual Reality
• Intervention / Treatment: Other: Immersive virtual reality; Other: Non-immersive virtual reality

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

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Acıbadem Mehmet Ali Aydınlar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with rheumatoid arthritis,
• Right hand dominant,

Exclusion criteria:

• A history of acute pain up to 3 days prior to the date of evaluation,
• Any psychiatric and neurological diagnosis,
• Have a cognitive problem that prevents them from adapting to the working procedure,
• Using centrally acting medications and anti-depressants.
• Presence of neuropathic pain,
• Presence of vision or hearing problems,
• Any psychiatric and neurological diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immersive Virtual Reality; Individuals will wear the headset for 10 minutes while playing NatureTrek application	Other: Immersive virtual reality; Oculus Quest 2 will be used with NatureTrek application for 10 minutes.
Active Comparator: Non-immersive Virtual Reality; Individuals will watch a video including scenes from NatureTrek application for 10 minutes.	Other: Non-immersive virtual reality; Patients will watch a video including scenes from NatureTrek application on a screen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional near infrared spectrosopy	Real-time measurement and monitoring of brain hemodynamics will be performed with a 24-channel fNIRS device (Brite 24, Artinis, The Netherlands). Recordings will be obtained with sensors placed in the prefrontal cortex. In the study design, after the sensors are placed on the scalp, a 1-minute recording will first be taken in the resting position. Afterwards, painful and painless mechanical stimuli will be given to the subjects during the viewing of fully immersive and non-immersive virtual reality environments.	During the intervention
Numeric Pain Rating Scale	Numeric Pain Rating Scale will be used to quantify pain severity after both virtual reality applications. Patients will be asked to report their pain numerically as 0: no pain; 10: unbearable pain.	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Level of Fun	The level of entertainment perceived by the participants after each virtual reality application will be evaluated on a scale of 0 to 10 (0 = not entertained at all, 10 = very entertained).	Immediately after the intervention
Heart rate variability	Heart rate variability will be assessed using a wearable belt (Polar OH1 heart rate monitor).	During the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale	Pain Catastrophizing Scale assesses catastrophic feelings associated with pain, is a Likert-type self-assessment scale consisting of 13 items rated between 0 and 4 points. The total score ranges from 0 to 52 and includes rumination, magnification and helplessness subscales. Higher scores on the scale indicate higher levels of pain catastrophizing.	Pre-intervention
Tampa Kinesiophobia Scale	Tampa Kinesiophobia Scale consists of 17 questions and is used to assess fear and avoidance behaviors in diseases related to musculoskeletal injuries. The scale uses a 4-point Likert scoring system (1=strongly disagree and 4=strongly agree). The total score is calculated after reversing questions 4, 8, 12 and 16 and ranges from 17 to 68. Higher scores indicate higher levels of kinesiophobia.	Pre-intervention
Adverse effects	VR related events included dizziness, nausea, eye strain, and seizure.	Immediately after the intervention
Pain Detect Questionnaire	PainDETECT is a validated self-report tool to identify neuropathic pain features in a range of conditions. Pain Detect Questionnaire consists of 17 questions, and the maximum score is 30. Scores equal or above 19 indicate the presense of likely neuropathic pain.	Pre-intervention

Collaborators and Investigators

• Sponsor: Acibadem University
• Collaborators: Kartal Dr. Lütfi Kirdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Actual): March 10, 2024
• Study Completion (Actual): March 19, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ATADEK 2022-14/06

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