Trial Outcomes & Findings for Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain (NCT NCT06814470)
NCT ID: NCT06814470
Last Updated: 2026-01-26
Results Overview
Proportion of subjects who complete all assessments from the total number of subjects who were enrolled in the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Through study intervention, an average of about four weeks
Results posted on
2026-01-26
Participant Flow
Participant milestones
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
n=15 Participants
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
n=16 Participants
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 year
STANDARD_DEVIATION 16 • n=25 Participants
|
50 year
STANDARD_DEVIATION 17 • n=25 Participants
|
49 year
STANDARD_DEVIATION 16.5 • n=50 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=25 Participants
|
11 Participants
n=25 Participants
|
24 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
7 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
4 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
5 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=25 Participants
|
10 Participants
n=25 Participants
|
18 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=25 Participants
|
16 Participants
n=25 Participants
|
31 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Through study intervention, an average of about four weeksProportion of subjects who complete all assessments from the total number of subjects who were enrolled in the study
Outcome measures
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
n=15 Participants
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
n=16 Participants
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
Retention
|
14 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: up to 4 weeksMean of the satisfaction score on a scale from 1 to 5, larger number indicated greater satisfaction. Assessed after each study interventions, an average score is reported.,
Outcome measures
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
n=14 Participants
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
n=14 Participants
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
Satisfaction to the Interventions
|
4.7 scores on a scale
Standard Deviation .33
|
3.9 scores on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Through study interventions, an average of about four weeksSymptoms and adverse events reported by the participants
Outcome measures
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
n=15 Participants
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
n=16 Participants
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
Number of Adverse Events (Safety of the Intervention)
|
0 number of adverse event
|
0 number of adverse event
|
SECONDARY outcome
Timeframe: baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.The PROMIS-29 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain. We use pain intensity in this report, low score indicates improvement.
Outcome measures
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
n=14 Participants
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
n=14 Participants
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
PROMIS-29
|
1 scores on a scale
Interval 0.2 to 1.8
|
0.5 scores on a scale
Interval 0.3 to 1.3
|
SECONDARY outcome
Timeframe: baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.Population: pre minus post intervention score is reported
This is a self-reported measure of cLBP pain severity that is commonly used to assess clinical chronic pain. Participants rate how bothersome their LBP was during the previous week with a VAS scale (0-10) from "not at all bothersome" (0) to "extremely bothersome" (10).
Outcome measures
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
n=14 Participants
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
n=14 Participants
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
Pain Bothersomeness Scale
|
2 scores on a scale
Interval 0.8 to 3.2
|
0.71 scores on a scale
Interval 0.5 to 1.9
|
SECONDARY outcome
Timeframe: up to 4 weeks.MASS is a scale developed to measure sensations evoked by acupuncture treatment (total range 0-120). The MASS will be applied after each treatment. We reported total score in this report (average of sum of each session). larger numbers indicate stronger sensations.
Outcome measures
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
n=14 Participants
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
n=14 Participants
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
MGH Acupuncture Sensation Scale (MASS)
|
9.0 unit on a scale
Standard Deviation 10.0
|
4.5 unit on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: After each study interventions, the average score is reported.Vividness Scale is a 0-10 vividness scale to measure imagery vividness during the intervention. The scale ranges from Not Vivid/Unclear (0) to Vivid/Clear (10).
Outcome measures
| Measure |
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
n=14 Participants
Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation
|
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
n=14 Participants
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching
|
|---|---|---|
|
Vividness Scale
|
8.6 the unit on the scale
Standard Deviation 1.7
|
7.9 the unit on the scale
Standard Deviation 2.0
|
Adverse Events
Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control
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