search
Back to results

Virtual Reality for Osteoarthritis Knee Pain Pilot (VROA)

Primary Purpose

Osteoarthritis of the Knee

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Training Session
3D viewer with iPod Touch/iPhone (or similar smartphone)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Osteoarthritis of the Knee

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center department Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain Coping Training with 3D viewer

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of Virtual Reality in Pain Coping
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.

Secondary Outcome Measures

Change in self reported pain
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.

Full Information

First Posted
June 26, 2013
Last Updated
August 3, 2023
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT01899508
Brief Title
Virtual Reality for Osteoarthritis Knee Pain Pilot
Acronym
VROA
Official Title
Virtual Reality for Osteoarthritis Knee Pain Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
The study has been terminated, due to technically difficulties.
Study Start Date
January 2015 (Actual)
Primary Completion Date
August 17, 2015 (Actual)
Study Completion Date
August 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Coping Training with 3D viewer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Virtual Reality Training Session
Intervention Description
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
Intervention Name(s)
3D viewer with iPod Touch/iPhone (or similar smartphone)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Virtual Reality in Pain Coping
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). 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.
Time Frame
1.5 hours
Secondary Outcome Measure Information:
Title
Change in self reported pain
Description
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.
Time Frame
1.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franicis Keefe, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center department Psychiatry
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Virtual Reality for Osteoarthritis Knee Pain Pilot

We'll reach out to this number within 24 hrs