Virtual Reality for Osteoarthritis Knee Pain Pilot

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.

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.