Knee OsteoarthritisNCT04951661
Virtual Reality and Older Adult Knee OA
A study testing Virtual Reality in people with Knee Osteoarthritis, run by Tufts University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2021to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Eye infections
- Has a pacemaker or defibrillator
- Has a hearing aid
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Pain Management Center
Chestnut Hill, Massachusetts, 02467
About this study
Official title: The Feasibility & Effectiveness of Virtual Reality in Reducing Pain for Older Adults With Knee Osteoarthritis
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.
Read the 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
- Being tested
- Virtual Reality
- Keywords
- Knee Osteoarthritis, Virtual Reality, Pain, Knee Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: pre-intervention
Secondary outcomes (6)
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.
Measured: pre-intervention
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.
Measured: within 20 minutes after intervention
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.
Measured: within 20 minutes after intervention
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.
Measured: within 20 minutes after intervention
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).
Measured: within 20 minutes after intervention
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.
Measured: within 20 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start19 Jun 2021
- Primary completion16 Aug 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Nancy Baker, Tufts University
- Investigators
- Nancy A Baker, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951661
- Sponsor's protocol ID
- STUDY00001433
- Status last verified
- Feb 2022
- First submitted
- 10 Jun 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32010701Billups, 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, 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.
PubMed 16682240Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
PubMed 24024017Hoffman 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.
PubMed 24892204Jones 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.
PubMed 27997539Kennedy, 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.
PubMed 20691523Maskey 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.
PubMed 30767156Mendoza 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.
PubMed 16051509Nakad, 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.
PubMed 31474851Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.
PubMed 33406330Zhang 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.
PubMed 18279766
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility & Effectiveness of Virtual Reality in Reducing Pain for Older Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04951661
- Acronym / sponsor ID
- STUDY00001433
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Virtual Reality, Pain, Knee Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Device: Virtual RealityParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Received steroid injection within 2 weeks of VR session
- Unwilling to put on VR headset
- Diagnosed seizure disorder
- Cognitive impairment
- Hearing/visual deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityParticipants 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 | All Participants |
Primary outcome
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".
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).
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.
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.
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.
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).
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).
6 secondary outcomes
Baseline Survey
Time frame: pre-intervention
Simulator Sickness Questionnaire [SSQ]21
Time frame: within 20 minutes after intervention
User Engagement Scale [UES]22
Time frame: within 20 minutes after intervention
iGroup Presence Questionnaire (IPQ)
Time frame: within 20 minutes after intervention
Meditation Experience Questionnaire (MEQ)
Time frame: within 20 minutes after intervention
Open Ended Questions
Time frame: within 20 minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 32010701Appel 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.
- BackgroundBillups, 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: PubMed 16682240Bjordal 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.
- Background: PubMed 24024017Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
- Background: PubMed 24892204Hoffman 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.
- Background: PubMed 27997539Jones 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.
- BackgroundKennedy, 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: PubMed 20691523Malloy 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.
- Background: PubMed 30767156Maskey 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.
- Background: PubMed 16051509Mendoza 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.
- BackgroundNakad, 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
- BackgroundNIH Pain Consortium. (n.d.). Chronic pain in older adults. https://www.painconsortium.nih.gov/sites/default/files/aging_and_chronic_pain_infographic_508.pdf
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Baker principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Knee Osteoarthritis, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numerical Rating Scale [NRS] (Change) (time frame: pre-intervention, within 20 minutes after intervention, 24-48 hour follow-up after intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04951661, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.