Clinical trial NCT01899508: Virtual Reality for Osteoarthritis Knee Pain Pilot
Official title: Virtual Reality for Osteoarthritis Knee Pain Pilot
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is looking at whether virtual reality combined with pain coping skills training helps reduce pain in people who suffer from OA of the knee. Eligible participants will be asked to come into the study offices for one visit where they will fill out a couple of questionnaires, do some low impact performance tasks and be taught pain coping skills while looking into a 3D virtual reality viewer.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Virtual Reality in Pain Coping
timeFrame: 1.5 hours
Secondary outcomes:
measure: Change in self reported pain
timeFrame: 1.5 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center department Psychiatry
state: North Carolina
Study officials:
affiliation: Duke University
name: Franicis Keefe, PhD
role: PRINCIPAL_INVESTIGATOR
References: