Virtual Reality and Older Adult Knee OA

Knee Osteoarthritis Clinical Trial

Official title:

The Feasibility & Effectiveness of Virtual Reality in Reducing Pain for Older Adults With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951661
• Other study ID #: STUDY00001433
• Status: Completed
• Phase: N/A
• Start date: June 19, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: February 2022
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 10, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Virtual Reality
Participants will be set up in the VR equipment. They will engage and follow along with a 10-20 minute guided meditation through the VR. The meditation program may include simulated movement, relaxing music, and the voice of a meditation guide. The research team member will supervise the session, ensuring safety of the subject is maintained.

Locations

Country	Name	City	State
United States	Brigham & Women's Pain Management Center	Chestnut Hill	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View 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

Bjordal JM, Klovning A, Ljunggren AE, Slørdal 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. Epub 2006 May 8. — View Citation

Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12. Review. — View 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. — View 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. — View 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

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. Review. — View 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. — View 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. Epub 2005 Jul 26. — View 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

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

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. — View Citation

Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. Review. — View 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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Numerical Rating Scale [NRS] (Change)	Measures the intensity of pain on an 11-point scale, ranging from 0-10. 0 is no "pain", and 10 is "pain as bad as you can imagine".	pre-intervention, within 20 minutes after intervention, 24-48 hour follow-up after intervention
Primary	Brief Pain Inventory-Short Form (Change)	Fifteen-item self-report questionnaire that measures participant's various levels of pain severity in the past 24 hours, and perception of the degree to which pain prevents participation in important daily activities (e.g. work, socialization) and enjoyment of life. Eight pain severity items are rated on a 11-point scale of 0 (no pain) to 10 (pain as bad as you can imagine). Seven pain interference items are rated on a 11-point scale of 0 (does not interfere) to 10 (completely interferes).	pre-intervention, 24-48 hour follow-up after intervention
Primary	PROMIS Emotional Distress - Short Form (Change)	24-item self report questionnaire that measures how often participant experiences feelings related to depression, anxiety and anger in the past seven days. These questionnaires have been modified to ask about the past 24 hours. The questionnaire uses a 5-point Likert scale, from 1 (never) to 5 (always). This questionnaire will assess the participant's psychological state.	pre-intervention, 24-48 hour follow-up after intervention
Primary	Positive and Negative Affect Scale [PANAS] (Change)	This ten-item self-report questionnaire measures the extent to which the participant felt various emotions right now. This questionnaire uses a 5-point Likert scale, from 1 (very slightly or not at all) to 5 (extremely). This questionnaire will assess the participant's psychological state at all three data collection points.	pre-intervention, within 20 minutes after intervention, 24-48 hour follow-up after intervention
Primary	Patient Global Impression of Change [PGIC] (Change)	1-item self-report questionnaire that measures subject's pain since the start of the study intervention using a 7-point Likert scale from 0 (very much improved) to 6 (very much worse). This questionnaire will determine if the subject found the VR intervention to be helpful in reducing their pain.	within 20 minutes after intervention, 24-48 hour follow-up after intervention
Primary	Pain Catastrophizing Scale [PCS] (Change)	Thirteen-item self-report questionnaire that collects data on the types of thoughts and feelings the participants have when in pain. The participants will be asked to rank the degree to which they have certain thoughts and feelings when they are in pain using a 5-point Likert scale, from 0 (not at all) to 4 (all the time).	pre-intervention, 24-48 hour follow-up after intervention
Primary	Survey of Pain Attitudes - Brief [SOPA]	30-item self-report questionnaire that measures participant's perceptions of and attitudes towards their pain. The participants will be asked to rank how true each statement is for them using a 5-point Likert scale, from 0 (very untrue) to 4 (very true).	pre-intervention
Secondary	Baseline Survey	Obtains demographics, medical history, perceptions/attitudes of pain, and experiences with VR. Perceptions and attitudes towards pain will be obtained using the Pain Catastrophizing Scale17 and the Survey of Pain Attitudes19.	pre-intervention
Secondary	Simulator Sickness Questionnaire [SSQ]21	List of sixteen symptoms which are commonly experienced by users of virtual reality systems. Participants rate the severity of these symptoms while using the VR system using a 4-point Likert scale from 1 (none) to 4 (severe). This questionnaire will monitor the extent of motion sickness in our participants.	within 20 minutes after intervention
Secondary	User Engagement Scale [UES]22	Twelve-item self-report questionnaire that measures the participant's perception of how engaged they were with the experience using a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). This questionnaire will determine immersion into VR.	within 20 minutes after intervention
Secondary	iGroup Presence Questionnaire (IPQ)	Fourteen-item self-report questionnaire that measures participant's perception of presence in computer-made Virtual Environments using various 7-point Likert scales. This questionnaire will determine immersion into VR.	within 20 minutes after intervention
Secondary	Meditation Experience Questionnaire (MEQ)	Thirteen-item self-report questionnaire that asks subjects to rate the frequency of occurrence of various experiences, such as fatigue, pleasant/unpleasant thoughts, and thoughts about planning or memories, during meditation intervention to evaluate quality of meditation immersion. Uses 5-point Likert scale from 1 (never) to 5 (almost constantly).	within 20 minutes after intervention
Secondary	Open Ended Questions	People in VR group will also be asked a series of open-ended questions about their experiences with VR and the study. Their responses will be audio recorded and later transcribed. These files will be stored in a password protected file that only study personnel have access to.	within 20 minutes after intervention