Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot

Virtual Reality Treatment in a Methadone Maintenance Treatment Program for Chronic Pain and Opioid Use Disorder

This is a pilot feasibility study of a virtual reality device for patients with co-morbid chronic pain and opioid use disorder.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Use Disorder
• Intervention / Treatment: Device: RelieVRx; Device: Sham VR

Detailed Description

The investigators will conduct a study of patients with co-morbid chronic pain and opioid use disorder enrolled in a methadone maintenance treatment program (MMTP) to pilot device feasibility and measure changes in pain intensity and opioid craving. All patients will be randomized to one of each of the following arms: 1) RelieVRx (intervention group) or 2) Non-immersive sham VR (control group).

The intervention being piloted is the RelieVRx - AppliedVR, Los Angeles, CA - VR hardware and software. RelieVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.

RelieVRx is typically delivered in a 56-day program through daily virtual experiences, with each experience lasting between 2 and 16 minutes. In this pilot study, the investigators will conduct virtual experiences twice weekly at the MMTP. Over 6 weeks, participants in both groups will participate in 20-30 minute VR sessions twice per week. Each session will last about 20-30 minutes and go through 1-5 virtual experiences. The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx. Control participants will similarly experience 1-5 virtual experiences in each 20-30 session.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10451
      • Melrose Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥18 years old
2. English proficiency
3. receiving methadone treatment for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) confirmed Opioid Use Disorder (OUD) in the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability
4. chronic pain of at least moderate pain severity (score ≥4 on the Pain, Enjoyment of Life, and General Activity (PEG) scale)
5. willingness to participate in all study components
6. ability to provide informed consent, assessed using consent teach-back

Exclusion Criteria:

1. conditions that could make participation in VR hazardous or cause adverse effects (current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines, any medical condition predisposing to nausea or dizziness, hypersensitivity to flashing light or motion)
2. conditions that could prevent proper use of the VR headset (stereoscopic vision or severe hearing impairment, or injury to eyes, face, or neck that prevents use of the VR headset)
3. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RelieVRx; RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks.	Device: RelieVRx; The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.
Sham Comparator: Sham Virtual Reality; The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks.	Device: Sham VR; The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	The investigators will use the Pain, Enjoyment of Life and General Activity scale (scored 1-10) to measure change in pain intensity. Higher scores indicate greater pain intensity.	baseline, 6 weeks
Change in Opioid Craving	The investigators will use the Opioid Craving Visual Analog Scale (scored 0-100) to measure opioid craving. Higher scores indicate greater opioid craving.	baseline, 6 weeks
Percent of participants contacted that are enrolled	The investigators will determine feasibility by measuring the percentage of participants that are contacted who are enrolled.	baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Interference	The investigators will use the Patient-Reported Outcomes Measurement Information System Pain Intensity Subscale to measure change in pain intensity. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates greater pain interference.	baseline, 3 weeks, 6 weeks
Change in Sleep	The investigators will use the Patient-Reported Outcomes Measurement Information System Short Form 6a to assess changes in sleep. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates higher sleep quality.	baseline, 3 weeks, 6 weeks
Change in Opioid Prescription	The investigators will use Prescription Monitoring Program (PMP) records to assess changes in participants' opioid prescriptions.	baseline, 3 weeks, 6 weeks
Change in Cognitive Function	The investigators will use the Patient-Reported Outcomes Measurement Information Cognitive Function to assess changes in cognitive function. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates greater impairments in cognitive function.	baseline, 3 weeks, 6 weeks
Change in Social Function	The investigators will use the Patient-Reported Outcomes Measurement Information Ability to Participate Social 4a Heal to assess changes in social function. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater inhibition to social participation.	baseline, 3 weeks, 6 weeks
Change in Physical Function	The investigators will use the Patient-Reported Outcomes Measurement Information Ability to Participate Social 6b Heal to assess changes in social function. Every question for this measure has five answer options spanning from 'Without any difficulty' to 'Unable to do'. A higher score indicates greater inhibition in physical function.	baseline, 3 weeks, 6 weeks
Change in Depression	The investigators will use the Patient-Reported Outcomes Measurement Information Depression 4a Heal to assess changes in depression. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater depression symptoms.	baseline, 3 weeks, 6 weeks
Change in Anxiety	The investigators will use the Patient-Reported Outcomes Measurement Information Anxiety 4a Heal to assess changes in anxiety. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater anxiety symptoms.	baseline, 3 weeks, 6 weeks
Illicit Opioid Use	The investigators will use the Patient-Reported Outcomes Measurement Information Opioid Misuse to measure illicit opioid use. Every question for this measure has five answer options spanning from 'Never' to 'Almost Always'. A higher score indicates a greater level of illicit opioid use.	baseline, 3 weeks, 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress	The investigators will use the Perceived Stress Scale to measure changes in stress. Every question for this measure has five answer options spanning from 'Never' to 'Very Often'. A higher score indicates greater stress.	baseline, 3 weeks, 6 weeks
Change in Salivary Cortisol	The investigators will collect saliva the morning of each time frame and test for cortisol, which is a chronic pain inflammatory biomarker. Higher levels of salivary cortisol may indicate greater chronic pain symptoms.	baseline, 3 weeks, 6 weeks
Change in Serum Cortisol	The investigators will collect blood and urine samples at each time frame and test for serum cortisol, which is a chronic pain inflammatory biomarker. Higher levels of serum cortisol may indicate greater chronic pain symptoms.	baseline, 3 weeks, 6 weeks
Change in Serum C-reactive Protein	The investigators will collect blood samples at each time frame and test for serum c-reactive protein, which is a chronic pain inflammatory biomarker. Higher levels of serum c-reactive protein may indicate greater chronic pain symptoms.	baseline, 3 weeks, 6 weeks
Change in Serum Cytokines	The investigators will collect blood samples at each time frame and test for serum cytokines, which is a chronic pain inflammatory biomarker. Higher levels of serum c-reactive protein may indicate greater chronic pain symptoms.	baseline, 3 weeks, 6 weeks

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Hector Perez, MD, MS, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Substance-Related Disorders; Chronic Pain; Opioid-Related Disorders
• Other Study ID Numbers: 2022-14257

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: Yes
• product manufactured in and exported from the U.S.: Yes