Virtual Reality and Older Adult Knee OA

NCT04951661 | Completed

• 1 other identifier: STUDY00001433
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Virtual Reality; Pain; Knee Pain

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Baseline Survey

  pre-intervention

• Simulator Sickness Questionnaire [SSQ]21

  within 20 minutes after intervention

• User Engagement Scale [UES]22

  within 20 minutes after intervention

• iGroup Presence Questionnaire (IPQ)

  within 20 minutes after intervention

• Meditation Experience Questionnaire (MEQ)

  within 20 minutes after intervention

Study Arms (1)

All Participants

EXPERIMENTAL

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.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

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.

All Participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Received steroid injection within 2 weeks of VR session
• Unwilling to put on VR headset
• Diagnosed seizure disorder
• Cognitive impairment
• Hearing/visual deficit
• Active, contagious skin infection
• Eye infections
• Has a pacemaker or defibrillator
• Has a hearing aid

Sponsors & Collaborators

• Tufts University: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Brigham & Women's Pain Management Center

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (16)

• 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.

  PMID: 32010701 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16682240 BACKGROUND

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

  PMID: 24024017 BACKGROUND

• 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.

  PMID: 24892204 BACKGROUND

• 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.

  PMID: 27997539 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20691523 BACKGROUND

• 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.

  PMID: 30767156 BACKGROUND

• 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.

  PMID: 16051509 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31474851 BACKGROUND

• Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.

  PMID: 33406330 BACKGROUND

• 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.

  PMID: 18279766 BACKGROUND

• 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.

  PMID: 35750655 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy A Baker

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of and Associate Professor in Department of Occupational Therapy

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 7, 2021
• Study Start: June 19, 2021
• Primary Completion: August 16, 2021
• Study Completion: September 10, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)