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Virtual Reality and Older Adult Knee OA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04951661
Recruitment Status : Active, not recruiting
First Posted : July 7, 2021
Last Update Posted : August 20, 2021
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Nancy Baker, Tufts University

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Virtual Reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility & Effectiveness of Virtual Reality in Reducing Pain for Older Adults With Knee Osteoarthritis
Actual Study Start Date : June 19, 2021
Estimated Primary Completion Date : August 16, 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: All Participants
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
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.




Primary Outcome Measures :
  1. Pain Numerical Rating Scale [NRS] (Change) [ Time Frame: pre-intervention, within 20 minutes after intervention, 24-48 hour follow-up after intervention ]
    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".

  2. Brief Pain Inventory-Short Form (Change) [ Time Frame: pre-intervention, 24-48 hour follow-up after intervention ]
    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).

  3. PROMIS Emotional Distress - Short Form (Change) [ Time Frame: pre-intervention, 24-48 hour follow-up after intervention ]
    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.

  4. Positive and Negative Affect Scale [PANAS] (Change) [ Time Frame: pre-intervention, within 20 minutes after intervention, 24-48 hour follow-up after intervention ]
    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.

  5. Patient Global Impression of Change [PGIC] (Change) [ Time Frame: within 20 minutes after intervention, 24-48 hour follow-up after intervention ]
    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.

  6. Pain Catastrophizing Scale [PCS] (Change) [ Time Frame: pre-intervention, 24-48 hour follow-up after intervention ]
    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).

  7. Survey of Pain Attitudes - Brief [SOPA] [ Time Frame: pre-intervention ]
    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).


Secondary Outcome Measures :
  1. Baseline Survey [ Time Frame: pre-intervention ]
    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.

  2. Simulator Sickness Questionnaire [SSQ]21 [ Time Frame: within 20 minutes after intervention ]
    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.

  3. User Engagement Scale [UES]22 [ Time Frame: within 20 minutes after intervention ]
    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.

  4. iGroup Presence Questionnaire (IPQ) [ Time Frame: within 20 minutes after intervention ]
    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.

  5. Meditation Experience Questionnaire (MEQ) [ Time Frame: within 20 minutes after intervention ]
    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).

  6. Open Ended Questions [ Time Frame: within 20 minutes after intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951661


Locations
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United States, Massachusetts
Brigham & Women's Pain Management Center
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Tufts University
Brigham and Women's Hospital
Investigators
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Principal Investigator: Nancy A Baker Tufts University
Publications:
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
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
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

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Responsible Party: Nancy Baker, Chair of and Associate Professor in Department of Occupational Therapy, Tufts University
ClinicalTrials.gov Identifier: NCT04951661    
Other Study ID Numbers: STUDY00001433
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nancy Baker, Tufts University:
Knee Osteoarthritis
Virtual Reality
Pain
Knee Pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases