Clinical trial NCT04345575: Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain
Official title: Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: virtual reality
chronic pain
behavioral health
behavioral medicine
Lead sponsor: AppliedVR Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-14
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group design where enrolled participants are randomly assigned to one of two treatment groups: Virtual reality behavioral medicine for chronic pain or Audio behavioral medicine for chronic pain
Primary purpose: TREATMENT

Brief summary: Chronic pain management is optimized with a multidisciplinary biopsychosocial treatment approach. However, patients have limited access to comprehensive care that includes behavioral medicine for chronic pain. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapeutic with analgesic efficacy for acute pain. No scientific literature was found for skills-based VR behavioral programs for chronic pain populations.

The primary goal of this study was to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based cognitive behavioral treatment for chronic pain. The secondary goal was to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary goal was to conduct a randomized controlled trial to compare the VR treatment to an audio-only treatment; this comparison isolated the immersive effects of the skills-based VR program, thereby informing potential mechanisms of effect.

Detailed description: This randomized controlled clinical trial was conducted between March and May of 2019. Participants were recruited through online advertisements on Facebook and The Mighty, a digital health community. Screening included a 2-item measure to assess for anhedonia and depressive symptoms experienced over the past two weeks. Potential participants were excluded from the study if they endorsed experiencing either depression or anhedonia nearly every day, and the other more than half the days. Eligible study participants were English-fluent adults 18-65 years of age, with either self-reported chronic low back pain without radicular symptoms and/or fibromyalgia pain of \> 6 months duration,\[29\] and with average pain intensity \> 4 (using the 11-point Numerical Rating Scale; 0=no pain, 10=worst pain imaginable) over the past month at screening. Exclusionary criteria included cognitive impairment, medical condition predisposing one to nausea or dizziness, hypersensitivity to flashing light or motion, absence of stereoscopic vision, severe hearing impairment, facial/head injury that would cause discomfort with VR use, cancer-related pain, severe depression, active suicidality, and previous use of Pain Care VR.

After informed consent was obtained study participants were randomized one-to-one using a REDCAP Cloud random number generator and allocated to treatment group. All study procedures were completed remotely and no in-person visits were required. Study participants were not blinded to treatment group assignment due to the obvious nature of the mode of delivery of their assigned treatment. Participant compensation was prorated based on the number of surveys completed; participants received up to $30 in the form of an Amazon.com e-gift card following completion of the final study survey. The study was approved by the Western Institutional Review Board (Puyallup, WA).

Data collection consisted of electronically collected patient-reported measures and objective use data collected from the VR devices and audio access logs.

In accordance with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations, multiple methods evaluated the importance of change in outcome measures across four recommended domains: pain intensity, health-related quality of life as defined by physical functioning, and ratings of overall Improvement.

Both treatment groups received the same didactic content delivered in distinct formats (VR vs. Audio). Treatment content consisted of a variety of sessions to support participants in learning cognitive and behavioral self-management skills based on evidence-based CBT principles and skills, biofeedback and mindfulness strategies used in pain management.

The 21-day program consisted of 4-8 treatment sessions from each content category with the duration of session length ranging from 1-15 minutes. Each treatment session was indexed as complete if participants initiated the experience. Participants were allowed to replay completed sessions.

Eligibility criteria: Inclusion Criteria:

* English-fluent
* adults 18-65 years old
* have either self-reported chronic low back pain without radicular symptoms and/or fibromyalgia pain of \> 6 months duration
* average pain intensity \> 4 (using the 11-point Numerical Rating Scale; 0=no pain, 10=worst pain imaginable) over the past month at screening.

Exclusion Criteria:

* Cognitive impairment
* Current or prior diagnosis of epilepsy, dementia, migraines or other neurological disease that may prevent the use of VR
* Hypersensitivity to flashing light or motion
* No stereoscopic vision or severe hearing impairment
* Injury to eyes, face or neck that prevents comfortable use of VR
* Pain related to cancer
* Active suicidal ideation or severe depression
* Previous use of Pain Care VR for pain

Primary outcomes:
measure: VR use
timeFrame: Day 1 through Day 21
measure: VR satisfaction
timeFrame: Day 22
measure: VR Nausea and motion sickness
timeFrame: Day 22
Secondary outcomes:
measure: Average Pain Intensity
timeFrame: Baseline and Day 21
measure: Pain Interference
timeFrame: Baseline and Day 21
measure: Pain-related Activity Interference
timeFrame: Baseline and Day 21
measure: Pain-related Mood Interference
timeFrame: Baseline and Day 21
measure: Pain-related Sleep Interference
timeFrame: Baseline and Day 21
measure: Pain-related Stress Interference
timeFrame: Baseline and Day 21
measure: Pain Catastrophizing
timeFrame: Baseline and Day 22
measure: Pain Self-Efficacy
timeFrame: Baseline and Day 22
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AppliedVR, Inc.
state: California
Study officials:
affiliation: Stanford University
name: Beth Darnall, PhD
role: PRINCIPAL_INVESTIGATOR
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