Virtual Reality for Osteoarthritis Knee Pain Pilot

NCT ID: NCT01899508

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-17

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.

Conditions

Osteoarthritis of the Knee

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Training Session

Intervention Type: PROCEDURE

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.

3D viewer with iPod Touch/iPhone (or similar smartphone)

Intervention Type: DEVICE

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.

Interventions

Virtual Reality Training Session

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.

Intervention Type: PROCEDURE

3D viewer with iPod Touch/iPhone (or similar smartphone)

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franicis Keefe, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center department Psychiatry

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00045175

Identifier Type: -

Identifier Source: org_study_id