Trial Outcomes & Findings for EaseVRx for the Reduction of Chronic Pain and Opioid Use (NCT NCT04139564)
NCT ID: NCT04139564
Last Updated: 2024-03-27
Results Overview
Numerical Pain Rating Scale; scale from 0 to 10 with higher numbers implying greater pain The outcome values presented below are the difference between baseline pain and pain at 12 weeks. Specifically, baseline pain score minus 12 week pain score A positive difference implies that pain was reduced
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-03-27
Participant Flow
Participant milestones
| Measure |
EaseVRx Group
Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program.
EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain
|
Active Control Group VR Sham
Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
55
|
|
Overall Study
COMPLETED
|
52
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EaseVRx for the Reduction of Chronic Pain and Opioid Use
Baseline characteristics by cohort
| Measure |
EaseVRx Group
n=52 Participants
Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program.
EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain
|
Active Control Group VR Sham
n=55 Participants
Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Numerical Pain Rating Scale
|
6.0 units on a scale from 0 to 10
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.9 units on a scale from 0 to 10
STANDARD_DEVIATION 1.5 • n=7 Participants
|
5.9 units on a scale from 0 to 10
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumerical Pain Rating Scale; scale from 0 to 10 with higher numbers implying greater pain The outcome values presented below are the difference between baseline pain and pain at 12 weeks. Specifically, baseline pain score minus 12 week pain score A positive difference implies that pain was reduced
Outcome measures
| Measure |
EaseVRx Group
n=52 Participants
Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program.
EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain
|
Active Control Group VR Sham
n=55 Participants
Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content
|
|---|---|---|
|
Pain: Numerical Pain Rating Scale
|
0.6 units on a scale
Standard Deviation 1.67
|
1.3 units on a scale
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: 12 weeksThirty four assessments were attempted. This measure notes the total number of assessments completed by each participant
Outcome measures
| Measure |
EaseVRx Group
n=51 Participants
Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program.
EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain
|
Active Control Group VR Sham
n=53 Participants
Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content
|
|---|---|---|
|
Number of Outcome Assessments Completed by Participant
|
30 total number of assessments completed
Standard Error 14.3
|
28 total number of assessments completed
Standard Error 15.7
|
SECONDARY outcome
Timeframe: 8 weeksnumber of VR modules completed. For the EaseVRx group this would be the number of EaseVRx modules completed with worst 0 - 56 best. For the Active control VR Sham group this would be the number of ShamVR modules completed with worst 0 - 56 best.
Outcome measures
| Measure |
EaseVRx Group
n=50 Participants
Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program.
EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain
|
Active Control Group VR Sham
n=48 Participants
Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content
|
|---|---|---|
|
Patient Compliance
|
37 modules
Standard Deviation 18.4
|
40 modules
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: 12 weeksMorphine Milligram Equivalents (MME)
Outcome measures
| Measure |
EaseVRx Group
n=45 Participants
Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program.
EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain
|
Active Control Group VR Sham
n=50 Participants
Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content
Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content
|
|---|---|---|
|
Opioid Consumption
|
6.75 Morphine Milligram Equivalents(MME)
Standard Error 3.37
|
5.67 Morphine Milligram Equivalents(MME)
Standard Error 2.56
|
Adverse Events
EaseVRx Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control Group VR Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place