Ignite Creation Date:
2024-05-06 @ 1:46 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01899508
Status:
TERMINATED
Last Update Posted:
2023-08-07
First Post:
2013-06-26
Brief Title:
Virtual Reality for Osteoarthritis Knee Pain Pilot
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Virtual Reality for Osteoarthritis Knee Pain Pilot
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has been terminated due to technically difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VROA
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 TouchiPhone 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 group30 patients with a clinical diagnosis of osteoarthritis OA of the knees 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 knees 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 andor 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 heshe may immediately remove the virtual reality device from hisher 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 andor 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
Study activities and population group30 patients with a clinical diagnosis of osteoarthritis OA of the knees 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 knees 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 andor 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 heshe may immediately remove the virtual reality device from hisher 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None