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Chronic PainNCT04345575

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain

A study testing PainCare VR and Audio content in people with Chronic Pain, run by AppliedVR Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Pain
What is being tested?
PainCare VR and Audio content
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteUnited States
Study dates
1 Mar 2019to 30 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AppliedVR, Inc.

    Los Angeles, California, 90067

Other trials in United States

About this study

Official title: Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: A Randomized Controlled Pilot Study

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.

Read the 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.

Conditions
Chronic Pain
Being tested
PainCare VR, Audio content
Keywords
virtual reality, chronic pain, behavioral health, behavioral medicine
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PainCare VRDevice

    Didactic content delivered in virtual reality to support participants in learning cognitive and behavioral self-management skills based on cognitive-based therapy, biofeedback, and mindfulness strategies for pain management.

  • Audio contentOther

    The audio program consisted of the majority of the same narrative content contained in the VR program. Owing to VR having a visual and auditory media form, about one-third of the VR program could not be included in the audio. Participants accessed 21 audio recordings on SoundCloud and asked to complete one session each day.

Study groups in NCT04345575
Study groupRoleWhat they receive
VR GroupExperimentalVR group participants were mailed an Oculus Go Virtual Reality headset preloaded with VR software developed by AppliedVR. Treatment content consisted of a variety of 21 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 program was designed to improve self-regulation of cognitive, emotion, and physiological response to stress and pain.
Receives: Device: PainCare VR
Audio GroupActive comparatorThe audio program consisted of the majority of the same narrative content contained in the VR program. Owing to VR having a visual and auditory media form, about one-third of the Audio program included didactic and experiential content that was not identifical but was closely matched to the VR content (sans references to visual imagery that would be confusing in the absence of visual content). Participants accessed 21 audio recordings on SoundCloud and asked to complete one session each day.
Receives: Other: Audio content

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VR use

    VR use will be calculated as the total number of sessions launched for the VR group.

    Measured: Day 1 through Day 21

  2. VR satisfaction

    Participant satisfaction ratings will be assessed using the question, "How satisfied or dissatisfied are you with the ability of this VR (Audio) program to relieve your symptoms" on a 5-point scale (1=Extremely Dissatisfied to 5=Extremely Satisfied). Satisfaction with treatment will be reported as percentages for the satisfaction categories 1-5 (on day 22).

    Measured: Day 22

  3. VR Nausea and motion sickness

    Nausea and motion sickness will be assessed on day 22 (post-treatment survey) using the question, "Did you experience any motion sickness or nausea while using VR?" on 4-point with 0=Never, 1=Sometimes, 2=Often, and 3=Always. The proportion of participants who did not experience any nausea/motion sickness will be reported.

    Measured: Day 22

Secondary outcomes (8)

  1. Average Pain Intensity

    Compare between group (VR vs Audio) pre-post treatment pain intensity (0-10 numeric rating scale) end of treatment on Day 21.

    Measured: Baseline and Day 21

  2. Pain Interference

    Department of Defense/Veterans Administration (DoD/VA) Scale assesses pain interference over the previous 24 hours at two time points: Baseline and end of treatment on Day 21 (0=does not interfere; 10=completely interferes). Between group (VR vs Audio) pre-post treatment for pain interference will be compared.

    Measured: Baseline and Day 21

  3. Pain-related Activity Interference

    Department of Defense/Veterans Administration (DoD/VA) Scale assesses activity interference over the previous 24 hours at two time points: Baseline and end of treatment on Day 21 (0=does not interfere; 10=completely interferes). Between group (VR vs Audio) pre-post treatment for activity interference will be compared.

    Measured: Baseline and Day 21

  4. Pain-related Mood Interference

    Department of Defense/Veterans Administration (DoD/VA) Scale assesses mood interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21(0=does not interfere; 10=completely interferes). The investigators will compare mood interference between group (VR vs Audio) pre-post treatment.

    Measured: Baseline and Day 21

  5. Pain-related Sleep Interference

    Department of Defense/Veterans Administration (DoD/VA) Scale assesses sleep interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21 (0=does not interfere; 10=completely interferes). The investigators will compare sleep interference between group (VR vs Audio) pre-post treatment.

    Measured: Baseline and Day 21

  6. Pain-related Stress Interference

    Department of Defense/Veterans Administration (DoD/VA) Scale assesses stress interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21 (0=does not interfere; 10=completely interferes). The investigators will compare stress interference between group (VR vs Audio) pre-post treatment .

    Measured: Baseline and Day 21

  7. Pain Catastrophizing

    Pain Catastrophizing Scale (PCS) assesses frequency of pain-related thoughts and feelings on a 0-4 scale (0=not at all; 4=all the time). The PCS is assessed at baseline and post-treatment at day 22. There is no specific time referent for this measure. The investigators compared PCS between group (VR vs Audio) pre-post treatment.

    Measured: Baseline and Day 22

  8. Pain Self-Efficacy

    The 2-item PSEQ (PSEQ-2) is used to assess pain self-efficacy. Respondents rate their responses to the items using a 7-point scale ranging from 0 (Not at all confident) to 4 (Completely confident). The two item scores are summed to create a total score. The investigators will compare pain self-efficacy (PSEQ-2) between group (VR vs Audio) pre-post treatment .

    Measured: Baseline and Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start1 Mar 2019
  3. Primary completion30 May 2019
  4. Study completion30 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04345575
Sponsor's protocol ID
2019-03
Status last verified
Apr 2020
First submitted
31 Mar 2020
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.

    PubMed 3461421

  • Turner JA, Anderson ML, Balderson BH, Cook AJ, Sherman KJ, Cherkin DC. Mindfulness-based stress reduction and cognitive behavioral therapy for chronic low back pain: similar effects on mindfulness, catastrophizing, self-efficacy, and acceptance in a randomized controlled trial. Pain. 2016 Nov;157(11):2434-2444. doi: 10.1097/j.pain.0000000000000635.

    PubMed 27257859

  • Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.

    PubMed 27002445

  • Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD007407. doi: 10.1002/14651858.CD007407.pub3.

    PubMed 23152245

  • Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses. Clin J Pain. 2017 Jun;33(6):552-568. doi: 10.1097/AJP.0000000000000425.

    PubMed 27479642

  • Darnall BD. Psychological Treatment for Patients with Chronic Pain. Washington, D.C.: American Psychological Association Press; 2018.

  • Darnall BD, Scheman J, Davin S, Burns JW, Murphy JL, Wilson AC, Kerns RD, Mackey SC. Pain Psychology: A Global Needs Assessment and National Call to Action. Pain Med. 2016 Feb;17(2):250-63. doi: 10.1093/pm/pnv095. Epub 2016 Jan 23.

    PubMed 26803844

  • Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.

    PubMed 31412029

  • Hoffman HG, Richards T, Coda B, Richards A, Sharar SR. The illusion of presence in immersive virtual reality during an fMRI brain scan. Cyberpsychol Behav. 2003 Apr;6(2):127-31. doi: 10.1089/109493103321640310.

    PubMed 12804024

  • Gold JI, Belmont KA, Thomas DA. The neurobiology of virtual reality pain attenuation. Cyberpsychol Behav. 2007 Aug;10(4):536-44. doi: 10.1089/cpb.2007.9993.

    PubMed 17711362

  • Geenen R, Bijlsma JW. Deviations in the endocrine system and brain of patients with fibromyalgia: cause or consequence of pain and associated features? Ann N Y Acad Sci. 2010 Apr;1193:98-110. doi: 10.1111/j.1749-6632.2009.05290.x.

    PubMed 20398014

  • Nararro-Haro MV, Hoffman HG, Garcia-Palacios A, Sampaio M, Alhalabi W, Hall K, Linehan M. The Use of Virtual Reality to Facilitate Mindfulness Skills Training in Dialectical Behavioral Therapy for Borderline Personality Disorder: A Case Study. Front Psychol. 2016 Nov 2;7:1573. doi: 10.3389/fpsyg.2016.01573. eCollection 2016.

    PubMed 27853437

  • Parsons TD, Rizzo AA. Affective outcomes of virtual reality exposure therapy for anxiety and specific phobias: a meta-analysis. J Behav Ther Exp Psychiatry. 2008 Sep;39(3):250-61. doi: 10.1016/j.jbtep.2007.07.007. Epub 2007 Jul 25.

    PubMed 17720136

  • Parsons TD, Rizzo AA, Rogers S, York P. Virtual reality in paediatric rehabilitation: a review. Dev Neurorehabil. 2009 Aug;12(4):224-38. doi: 10.1080/17518420902991719.

    PubMed 19842822

  • Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.

    PubMed 16640481

Questions about this trial

What is this clinical trial studying?

A study testing PainCare VR and Audio content in people with Chronic Pain, run by AppliedVR Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VR use (time frame: Day 1 through Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345575, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.

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Clinical Trial NCT04345575 | AzTrials