- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01899508
Virtual Reality for Osteoarthritis Knee Pain Pilot (VROA)
Study Overview
Status
Conditions
Detailed Description
The primary objective of this study is to examine the feasibility and acceptability of a new virtual reality (VR) protocol that uses an iPod Touch/iPhone (or similar smartphone) to deliver virtual reality (VR). The secondary objective of this study is to gather preliminary data on the efficacy and potential benefits of the VR protocol for individuals suffering from persistent osteoarthritis (OA) pain of the knees.
Study activities and population group:30 patients with a clinical diagnosis of osteoarthritis (OA) of the knee(s) will be recruited from the clinics of the Duke Division of Rheumatology and Duke Department of Orthopedic Surgery. All participants will complete screening measures, a baseline set of measures, a virtual reality training session, and post-training measures. Participants will include 30 OA patients. Inclusion criteria include: 1) having a diagnosis of OA of the knee(s), 2) age 18 or over, 3) able to read and speak English, 4) having OA related pain upon movement. 5) Self-reported normal or corrected to normal vision, 6) Self-reported normal hearing.
Cybersickness is a possible risk, a type of motion sicknesses often involving feelings of nausea, eyestrain and/or dizziness. Anticipated risks associated with cybersickness are comparable to typical "everyday" use of computers. If the participant begins to feel any effect of this type, he/she may immediately remove the virtual reality device from his/her eyes and stop the treatment. Patients will be asked to report these symptoms and will have the option of discontinuing participation if these symptoms are problematic. Third, participants may experience anxiety or distress due to questioning about thoughts, feelings, and/or their experience with OA pain. Again, participants will have the option to discontinue participation if they experience such problems in completing the measures. Finally, there is also the possibility of a breach of confidentiality. The informed consent process will address this possibility. All efforts will be made for confidentiality to be maintained. In terms of data analysis, a series of analyses will be performed to derive treatment effect size estimates (using eta squared) and their 95% confidence intervals for all outcomes. While the investigator expects mostly moderate effect sizes, given the sample size and the fact that this is a preliminary pilot study, the study team will examine within-group differences at an alpha of .10. To evaluate treatment effects on the outcome measures, the analytic strategy involves two analyses. In the first analysis, a multivariate analysis-of-variance model will be used to make within group comparisons that are unadjusted for baseline variables. In the second (primary) analysis, a multivariate analysis-of-covariance model will be used; covariates will be the pre-treatment scores on each of the outcome measures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Medical Center department Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be 18-85 years old
- Have a clinical diagnosis of OA of the knee
- Be able to read and write English
Exclusion Criteria:
- Can't have rheumatoid arthritis, fibromyalgia, or other chronic pain condition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pain Coping Training with 3D viewer
All participants will receive a 1 and a half hour pain coping training while using the virtual reality viewer.
We are testing the feasability of using the 3D viewer in collaboration with Pain Coping training to see if people who suffer from Osteoarthritis of the knee experience some pain relief.
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The participant will meet with an interventionist for an hour and a half long session.
During this session OA knee pain will be assessed (using self report questionnaires) prior to and post a 10 minute session using the 3D viewer and having a brief pain coping skills training.
The participant will meet with an interventionist for an hour and a half long session.
During this session OA knee pain will be assessed (using self report questionnaires) prior to and post a 10 minute session using the 3D viewer and having a brief pain coping skills training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Virtual Reality in Pain Coping
Time Frame: 1.5 hours
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The primary objective of this study is to examine the feasibility and acceptability of a new virtual reality (VR) protocol that uses an iPod Touch/iPhone (or similar smartphone) to deliver virtual reality (VR).
Feasibility will be assessed by examining overall accrual, attrition, and adherence to the study protocol.
Ratings on a standardized measure of treatment credibility will be examined as well as a Treatment Attitude Questionnaire to assess acceptability.
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1.5 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self reported pain
Time Frame: 1.5 hours
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Prior to and immediately following the participant's use of the 3D viewer they will be asked to rate their pain and complete questionnaires using the following scale to rate pain: Pain Self-Efficacy. Self-efficacy will be measured using the self-efficacy for pain management subscale of the 22-item Chronic Pain Self-Efficacy Scale (CPSS). The pain management subscale consists of 5 questions measuring levels of self-efficacy for pain management. For example, "How certain are you that you can decrease your pain quite a bit?", "How certain are you that you can continue most of your daily activities?" and "How certain are you that you can keep your pain from interfering with your sleep?". Participants circle the number that best corresponds with their certainty on a 10-point scale ranging in 10-point increments from 10 (very uncertain) to 100 (very certain). Scores for each question are averaged to give an overall value for self-efficacy for pain management. |
1.5 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Franicis Keefe, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00045175
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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