Study Stopped
The study has been terminated, due to technically difficulties.
Virtual Reality for Osteoarthritis Knee Pain Pilot
VROA
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2015
CompletedAugust 7, 2023
August 1, 2023
8 months
June 26, 2013
August 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1.5 hours
Secondary Outcomes (1)
Change in self reported pain
1.5 hours
Study Arms (1)
Pain Coping Training with 3D viewer
EXPERIMENTALAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Must be 18-85 years old
- Have a clinical diagnosis of OA of the knee
- Be able to read and write English
You may not qualify if:
- Can't have rheumatoid arthritis, fibromyalgia, or other chronic pain condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center department Psychiatry
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franicis Keefe, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
July 15, 2013
Study Start
January 1, 2015
Primary Completion
August 17, 2015
Study Completion
August 17, 2015
Last Updated
August 7, 2023
Record last verified: 2023-08