Virtual Reality and Older Adult Knee OA

NCT ID: NCT04951661

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-19
• Study Completion Date: 2021-09-10

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Nancy Baker

Chair of and Associate Professor in Department of Occupational Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy A Baker

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Brigham & Women's Pain Management Center

Chestnut Hill, Massachusetts, United States

Countries

United States

References

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Other Identifiers

STUDY00001433

Identifier Type: -

Identifier Source: org_study_id