Trial Outcomes & Findings for EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain (NCT NCT05263037)
NCT ID: NCT05263037
Last Updated: 2025-01-29
Results Overview
The BPI pain intensity questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The range of scores are from 0-10 with higher values implying greater pain intensity. The BPI pain intensity measure contains a single item related to pain intensity
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
1093 participants
Primary outcome timeframe
Day 56 (end of treatment)
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
56-day Skills-based VR Program
participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx
EaseVRx: VR software with interactive content
|
56-day Skills-based VR Program Followed by an Extended 56-day On-demand Period
participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment
EaseVRx: VR software with interactive content
|
56-day Control (Sham VR)
participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training
Sham VR: VR with neutral non-interactive content
|
• 56-day Control (Sham VR Plus 8w Extended On-demand)
participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting.
Sham VR: VR with neutral non-interactive content
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
275
|
272
|
273
|
273
|
|
Overall Study
COMPLETED
|
269
|
267
|
266
|
265
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain
Baseline characteristics by cohort
| Measure |
56-day Skills-based VR Program
n=269 Participants
participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx
EaseVRx: VR software with interactive content
|
56-day Skills-based VR Program Followed by an Extended 56-day On-demand Period
n=267 Participants
participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment
EaseVRx: VR software with interactive content
|
56-day Control (Sham VR)
n=266 Participants
participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training
Sham VR: VR with neutral non-interactive content
|
• 56-day Control (Sham VR Plus 8w Extended On-demand)
n=265 Participants
participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting.
Sham VR: VR with neutral non-interactive content
|
Total
n=1067 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
50 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
52 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
51 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
51 years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
210 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
777 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
290 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
178 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
729 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
111 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Brief Pain Inventory - Pain intensity
|
6.56 units on a scale
STANDARD_DEVIATION 1.48 • n=5 Participants
|
6.71 units on a scale
STANDARD_DEVIATION 1.47 • n=7 Participants
|
6.67 units on a scale
STANDARD_DEVIATION 1.44 • n=5 Participants
|
6.77 units on a scale
STANDARD_DEVIATION 1.54 • n=4 Participants
|
6.68 units on a scale
STANDARD_DEVIATION 1.48 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 56 (end of treatment)The BPI pain intensity questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The range of scores are from 0-10 with higher values implying greater pain intensity. The BPI pain intensity measure contains a single item related to pain intensity
Outcome measures
| Measure |
56-day Skills-based VR Program
n=269 Participants
participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx
EaseVRx: VR software with interactive content
|
56-day Skills-based VR Program Followed by an Extended 56-day On-demand Period
n=267 Participants
participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment
EaseVRx: VR software with interactive content
|
56-day Control (Sham VR)
n=266 Participants
participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training
Sham VR: VR with neutral non-interactive content
|
• 56-day Control (Sham VR Plus 8w Extended On-demand)
n=265 Participants
participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting.
Sham VR: VR with neutral non-interactive content
|
|---|---|---|---|---|
|
Brief Pain Inventory (BPI) Pain Intensity Questionnaire
|
4.51 units on a scale
Standard Deviation 2.22
|
4.83 units on a scale
Standard Deviation 2.11
|
5.25 units on a scale
Standard Deviation 2.15
|
5.17 units on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. Anticipated reporting date June 2027The ODI questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 10 items that are summed with a score ranging from 0 - 100%. The higher the score the greater the impact of chronic pain on the participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatmentThe PROMIS Sleep disturbance questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 8 items that are summed with a raw score range from 0 - 40. The higher the score the worse sleep.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatmentThe PROMIS Depression questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 8 items that are summed with a raw score range from 0 - 40. The higher the score the worse depression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatmentThe PROMIS Anxiety questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 7 items that are summed with a raw score range from 0 - 35. The higher the score the worse anxiety.
Outcome measures
Outcome data not reported
Adverse Events
56-day Skills-based VR Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
56-day Skills-based VR Program Followed by an Extended 56-day On-demand Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
56-day Control (Sham VR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
• 56-day Control (Sham VR Plus 8w Extended On-demand)
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