Trial Outcomes & Findings for Immersive Virtual Reality and Chronic Back Pain (NCT NCT04307446)
NCT ID: NCT04307446
Last Updated: 2023-08-15
Results Overview
Pain Intensity - Numerical rating scale 0 to 10 with lower score better score
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Change in Pain Intensity from before to immediately after intervention
Results posted on
2023-08-15
Participant Flow
Participant milestones
| Measure |
10 Minutes/20minutes
Subject takes part in 10 minute VR experience first and a 20 minute VR experience second
Immersive Virtual Reality: Immersive Virtual Reality
|
20 Minutes/10 Minutes
Subject takes part in 20 minute VR experience first and a 10 minute VR experience second
Immersive Virtual Reality: Immersive Virtual Reality
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
10 Minutes/20minutes
Subject takes part in 10 minute VR experience first and a 20 minute VR experience second
Immersive Virtual Reality: Immersive Virtual Reality
|
20 Minutes/10 Minutes
Subject takes part in 20 minute VR experience first and a 10 minute VR experience second
Immersive Virtual Reality: Immersive Virtual Reality
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Immersive Virtual Reality and Chronic Back Pain
Baseline characteristics by cohort
| Measure |
10 Minutes/20minutes
n=12 Participants
Subject takes part in 10 minute VR experience first and a 20 minute VR experience second
Immersive Virtual Reality: Immersive Virtual Reality
|
20 Minutes/10 Minutes
n=11 Participants
Subject takes part in 20 minute VR experience first and a 10 minute VR experience second
Immersive Virtual Reality: Immersive Virtual Reality
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 18.6 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 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
|
2 Participants
n=7 Participants
|
2 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Length of Pain
|
12.8 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
14.9 years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
13.9 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Previous IVR Experience
Yes
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Previous IVR Experience
No
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Previous IVR Experience
Don't Know
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in Pain Intensity from before to immediately after interventionPain Intensity - Numerical rating scale 0 to 10 with lower score better score
Outcome measures
| Measure |
10 Minutes VR
n=21 Participants
Received 10 minutes of VR (regardless of order)
|
20 Minutes
n=20 Participants
20 minutes of VR regardless of order
|
|---|---|---|
|
Pain Numerical Rating Scale
|
0.8 units on a scale
Standard Deviation 3.1
|
1.1 units on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Median Pre and post intervention sensitivity to pressure scores in kilogramsSensitivity to pressure will be assessed using a digital pressure algometer on the right upper trapezius and right thumb MP joint. The measures from each site were averaged to obtain an overall mean pressure score for each participant. A lower score indicates a better outcome.
Outcome measures
| Measure |
10 Minutes VR
n=21 Participants
Received 10 minutes of VR (regardless of order)
|
20 Minutes
n=20 Participants
20 minutes of VR regardless of order
|
|---|---|---|
|
Mechanical Pressure Pain Thresholds (MPPTh)
Pre Intervention
|
5.0 kilograms
Interval 2.5 to 9.6
|
5.0 kilograms
Interval 2.5 to 8.8
|
|
Mechanical Pressure Pain Thresholds (MPPTh)
Post Intervention
|
4.9 kilograms
Interval 2.6 to 8.4
|
5.1 kilograms
Interval 3.1 to 8.2
|
PRIMARY outcome
Timeframe: Change in Sensitivity to pinprick from before to immediately after interventionSensitivity to pinprick was assessed using weighted pinprick stimulators. We applied a train of 10 stimuli at the rate of 1 per second on the middle finger of the right hand, and subjects rated the painfulness of the first and tenth stimulus using a 1 to 100 pain intentsity rating scale. We calculated the difference from the 1st stimuus to the 10th stimulus to calculate the sensitivity. A lower change score is a better outcome
Outcome measures
| Measure |
10 Minutes VR
n=21 Participants
Received 10 minutes of VR (regardless of order)
|
20 Minutes
n=20 Participants
20 minutes of VR regardless of order
|
|---|---|---|
|
Mechanical Temporal Summation of Pain (MTSP)
Pre Intervention
|
8.5 units on a scale
Interval 1.0 to 40.0
|
10.0 units on a scale
Interval -0.5 to 47.5
|
|
Mechanical Temporal Summation of Pain (MTSP)
Post Intervention
|
8.8 units on a scale
Interval -2.0 to 31.0
|
8.8 units on a scale
Interval -2.5 to 65.0
|
SECONDARY outcome
Timeframe: Change in affect form before immediately after interventionTwo scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with lower score indicating less of that affect
Outcome measures
| Measure |
10 Minutes VR
n=21 Participants
Received 10 minutes of VR (regardless of order)
|
20 Minutes
n=20 Participants
20 minutes of VR regardless of order
|
|---|---|---|
|
PANAS
PANAS Positive
|
-1.1 units on a scale
Standard Deviation 2.3
|
-0.8 units on a scale
Standard Deviation 3.3
|
|
PANAS
PANAS Negative
|
-0.7 units on a scale
Standard Deviation 2.4
|
-0.1 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Change in fatigue from before to immediately after interventionFatigue on a scale of 0 to 28 with a lower score indicating less frequent experiences of fatigue
Outcome measures
| Measure |
10 Minutes VR
n=21 Participants
Received 10 minutes of VR (regardless of order)
|
20 Minutes
n=20 Participants
20 minutes of VR regardless of order
|
|---|---|---|
|
PROMIS Fatigue
|
0.1 units on a scale
Standard Deviation 1.3
|
-0.5 units on a scale
Standard Deviation 0.8
|
Adverse Events
10 Minutes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20 Minutes
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