Clinical trial NCT04951661: Virtual Reality and Older Adult Knee OA
Official title: The Feasibility & Effectiveness of Virtual Reality in Reducing Pain for Older Adults With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Virtual Reality
Pain
Knee Pain
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2021-07-07
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: At the Brigham and Women's Hospital (BWH) Pain Management Center (PMC), knee OA is one of the most common conditions causing older adults to experience chronic pain. At this site, the core treatments of education, physical activity, and weight management are addressed, and then both pharmacological and nonpharmacological treatment options are available for patients living with chronic pain. Pharmacological treatments, such as topical and oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, steroidal and non-steroidal injections, and prescription medications are currently the most commonly used treatments for chronic pain, but are also associated with limited benefits and dangerous side effects, such as addiction. Clients can also opt for nonpharmacological pain treatments at the PMC, such as acupuncture, reiki, physical therapy, and yoga, which are currently being researched at the clinic as well. The critical gap addressed with this pilot study is the need for additional safe and feasible treatment options for the growing population of older adults with chronic knee OA, as there is limited existing research on the effects of nonpharmacological treatments on this population. While past studies at the PMC have looked at the physiological mechanisms involved with chronic knee OA and the older adult population, the site has had limited funding to research nonpharmacological treatments such as virtual reality. In fact, there is limited evidence in the literature on the effects of virtual reality in reducing pain specifically for the older adult population.

Detailed description: Virtual reality has been shown to be feasible for a variety of populations, including young people with autism experiencing specific phobia, pediatric burn patients, and young adults. However, there is limited evidence on the feasibility of VR for treating pain for the older adult population. Preliminary studies demonstrate the feasibility and safe qualities of immersive VR as a treatment tool for older adults with cognitive and physical impairments. One study demonstrated that older adults reported no negative side effects and 76% of the group wanted to try VR again. Furthermore, preliminary evidence on the feasibility of use in the clinic in terms of the construct of time was demonstrated.

Another study found that young adults and older adults who engaged in an immersive spatial navigation VR environment reported similar experiences, demonstrating that older adults experienced acceptable adverse effects and reported enjoyment through the VR immersion. Further recent studies provide evidence on the attitudes and treatment acceptability of older adults with chronic musculoskeletal pain towards VR as a distraction therapy for chronic pain exacerbations. These researchers discovered that 73.4% of the participants found VR to be an acceptable way to manage pain, and 73.3% reported they would be willing to use it for their pain. Only 26% of the participants experienced side effects such as general discomfort or eyestrain. Additionally, the qualitative data in this study suggests greater ease of use with sufficient practice and a preference towards relaxation, meditation, or biofeedback simulations with realistic images.

Thirty percent of older adults in the United States report experiencing chronic pain, with 41% of this subset of the population experiencing chronic joint pain. Knee osteoarthritis (OA) affects 37% of individuals aged 60 years or older who participated in the National Health and Nutrition Examination. This condition typically involves pain, stiffness, reduced joint motion and muscle weakness, and chronic pain that can have profound effects on physical function, psychological parameters, and overall quality of life. In knee OA, cartilage in the knee is lost and there is failed repair of joint damage, as OA is a disease of the whole joint. There is also often a discrepancy between severity of symptoms and severity of knee OA, which may relate to pain sensitization, adaptation to chronic pain, or reduction in activity to avoid pain.

In Virtual Reality (VR) people experience a three-dimensional, computer-generated environment via a computer headset. There are several mechanisms through which VR has been shown to effectively reduce pain. For one, gate theory of attention proposes that VR reduces perception of pain by absorbing and diverting attention away from pain. Dr. Brennan Spiegel, director of Cedars-Sinai Health Services Research, reports that VR's ability to distract the brain allows the brain to relax. He states that this modality "triggers signals that release natural pain-killing opioids from the spinal cord, essentially closing the gate, blocking the pain". Therefore, VR distraction may be a useful tool for clinicians who work with clients experiencing a variety of pain-related conditions, such as chronic knee osteoarthritis.

This pilot study will build off of these preliminary studies by working from the basis that older adults generally enjoy their immersive VR experience and including some of the relevant key requirements for immersive environments such as individual briefing and user-friendly handling. There are still many questions that need to be answered about the feasibility of VR as a clinical tool and its effectiveness in decreasing chronic pain, specifically for older adults. Therefore, this pilot study will look more into these topic areas through a subset of the population of older adults with chronic pain.

Currently, there has been very little research that has examined the effect of VR on chronic pain, particularly for the older adult population. Knowledge on the effectiveness of VR for chronic pain for older adults is necessary to determine best methods to feasibly integrate VR into clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Adults over the age of 60 years old (no upper limit)
2. Diagnosis of chronic knee osteoarthritis with pain in at least one knee
3. English-speaking
4. Willing and able to visit the PMC campus to participate in the study

Exclusion Criteria:

1. Received steroid injection within 2 weeks of VR session
2. Unwilling to put on VR headset
3. Diagnosed seizure disorder
4. Cognitive impairment
5. Hearing/visual deficit
6. Active, contagious skin infection
7. Eye infections
8. Has a pacemaker or defibrillator
9. Has a hearing aid

Primary outcomes:
measure: Pain Numerical Rating Scale [NRS] (Change)
timeFrame: pre-intervention, within 20 minutes after intervention, 24-48 hour follow-up after intervention
measure: Brief Pain Inventory-Short Form (Change)
timeFrame: pre-intervention, 24-48 hour follow-up after intervention
measure: PROMIS Emotional Distress - Short Form (Change)
timeFrame: pre-intervention, 24-48 hour follow-up after intervention
measure: Positive and Negative Affect Scale [PANAS] (Change)
timeFrame: pre-intervention, within 20 minutes after intervention, 24-48 hour follow-up after intervention
measure: Patient Global Impression of Change [PGIC] (Change)
timeFrame: within 20 minutes after intervention, 24-48 hour follow-up after intervention
measure: Pain Catastrophizing Scale [PCS] (Change)
timeFrame: pre-intervention, 24-48 hour follow-up after intervention
measure: Survey of Pain Attitudes - Brief [SOPA]
timeFrame: pre-intervention
Secondary outcomes:
measure: Baseline Survey
timeFrame: pre-intervention
measure: Simulator Sickness Questionnaire [SSQ]21
timeFrame: within 20 minutes after intervention
measure: User Engagement Scale [UES]22
timeFrame: within 20 minutes after intervention
measure: iGroup Presence Questionnaire (IPQ)
timeFrame: within 20 minutes after intervention
measure: Meditation Experience Questionnaire (MEQ)
timeFrame: within 20 minutes after intervention
measure: Open Ended Questions
timeFrame: within 20 minutes after intervention
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham & Women's Pain Management Center
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Nancy A Baker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Appel L, Appel E, Bogler O, Wiseman M, Cohen L, Ein N, Abrams HB, Campos JL. Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. Front Med (Lausanne). 2020 Jan 15;6:329. doi: 10.3389/fmed.2019.00329. eCollection 2019.
citation: Billups, E. (2019, September 30). Hijacking the brain: Scientists are using VR to treat chronic pain. Spectrum News NY1. https://www.ny1.com/nyc/all-boroughs/exploring-your-health/2019/09/23/hijacking-the-brain--scientists-are-using-vr-to-treat-chronic-pain
citation: Bjordal JM, Klovning A, Ljunggren AE, Slordal L. Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: A meta-analysis of randomised placebo-controlled trials. Eur J Pain. 2007 Feb;11(2):125-38. doi: 10.1016/j.ejpain.2006.02.013. Epub 2006 May 8.
citation: Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
citation: Hoffman HG, Meyer WJ 3rd, Ramirez M, Roberts L, Seibel EJ, Atzori B, Sharar SR, Patterson DR. Feasibility of articulated arm mounted Oculus Rift Virtual Reality goggles for adjunctive pain control during occupational therapy in pediatric burn patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):397-401. doi: 10.1089/cyber.2014.0058.
citation: Jones T, Moore T, Choo J. The Impact of Virtual Reality on Chronic Pain. PLoS One. 2016 Dec 20;11(12):e0167523. doi: 10.1371/journal.pone.0167523. eCollection 2016.
citation: Kennedy, S., & Moran, M. (2010). Pharmacological treatment of osteoarthritis of the hip and knee. BCMJ, 52(8), 404-9. https://bcmj.org/articles/pharmacological-treatment-osteoarthritis-hip-and-knee
citation: Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.
citation: Maskey M, Rodgers J, Grahame V, Glod M, Honey E, Kinnear J, Labus M, Milne J, Minos D, McConachie H, Parr JR. A Randomised Controlled Feasibility Trial of Immersive Virtual Reality Treatment with Cognitive Behaviour Therapy for Specific Phobias in Young People with Autism Spectrum Disorder. J Autism Dev Disord. 2019 May;49(5):1912-1927. doi: 10.1007/s10803-018-3861-x.
citation: Mendoza T, Mayne T, Rublee D, Cleeland C. Reliability and validity of a modified Brief Pain Inventory short form in patients with osteoarthritis. Eur J Pain. 2006 May;10(4):353-61. doi: 10.1016/j.ejpain.2005.06.002. Epub 2005 Jul 26.
citation: Nakad, L., & Rakel, B. (2019). (271) Attitudes of Older Adults with Chronic Musculoskeletal Pain towards Immersive Virtual Reality. The Journal of Pain, 20(4), S42. https://doi.org/10.1016/j.jpain.2019.01.193
citation: NIH Pain Consortium. (n.d.). Chronic pain in older adults. https://www.painconsortium.nih.gov/sites/default/files/aging_and_chronic_pain_infographic_508.pdf
citation: Sakhare AR, Yang V, Stradford J, Tsang I, Ravichandran R, Pa J. Cycling and Spatial Navigation in an Enriched, Immersive 3D Virtual Park Environment: A Feasibility Study in Younger and Older Adults. Front Aging Neurosci. 2019 Aug 16;11:218. doi: 10.3389/fnagi.2019.00218. eCollection 2019.
citation: Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.
citation: Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
citation: Sarkar TD, Edwards RR, Baker N. The feasibility and effectiveness of virtual reality meditation on reducing chronic pain for older adults with knee osteoarthritis. Pain Pract. 2022 Sep;22(7):631-641. doi: 10.1111/papr.13144. Epub 2022 Jul 4.