Trial Outcomes & Findings for Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain (NCT NCT03261505)
NCT ID: NCT03261505
Last Updated: 2025-11-05
Results Overview
fMRI measures changes in brain activity by detecting fluctuations in blood oxygenation levels. The primary signal used in fMRI is the Blood Oxygen Level Dependent (BOLD) signal, which reflects neuronal activity indirectly through hemodynamic responses.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
Collected once during the first treatment session
Results posted on
2025-11-05
Participant Flow
Participant milestones
| Measure |
VGAIT
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
VGAIT Control
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Real Acupuncture
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Sham Acupuncture
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
34
|
31
|
|
Overall Study
COMPLETED
|
27
|
27
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
7
|
3
|
Reasons for withdrawal
| Measure |
VGAIT
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
VGAIT Control
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Real Acupuncture
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Sham Acupuncture
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
4
|
3
|
|
Overall Study
unrelated surgery preventing the subject participating the study
|
0
|
0
|
1
|
0
|
|
Overall Study
Claustrophobic or can not provide proof of diagnosis
|
0
|
0
|
2
|
0
|
|
Overall Study
the subject can not concentrate to complete the questionnaire
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
Baseline characteristics by cohort
| Measure |
VGAIT
n=30 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
VGAIT Control
n=30 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Real Acupuncture
n=34 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Sham Acupuncture
n=31 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=15 Participants
|
24 Participants
n=161 Participants
|
24 Participants
n=100 Participants
|
22 Participants
n=3 Participants
|
89 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=15 Participants
|
6 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
9 Participants
n=3 Participants
|
36 Participants
n=8 Participants
|
|
Age, Continuous
|
61.5 year
STANDARD_DEVIATION 8.2 • n=15 Participants
|
59.7 year
STANDARD_DEVIATION 7.8 • n=161 Participants
|
59.7 year
STANDARD_DEVIATION 7.6 • n=100 Participants
|
61.6 year
STANDARD_DEVIATION 7.4 • n=3 Participants
|
60.6 year
STANDARD_DEVIATION 7.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=15 Participants
|
20 Participants
n=161 Participants
|
22 Participants
n=100 Participants
|
20 Participants
n=3 Participants
|
79 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=15 Participants
|
10 Participants
n=161 Participants
|
12 Participants
n=100 Participants
|
11 Participants
n=3 Participants
|
46 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
5 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=15 Participants
|
27 Participants
n=161 Participants
|
27 Participants
n=100 Participants
|
26 Participants
n=3 Participants
|
106 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=15 Participants
|
30 participants
n=161 Participants
|
34 participants
n=100 Participants
|
31 participants
n=3 Participants
|
125 participants
n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Collected once during the first treatment sessionPopulation: SPM 12 was applied to investigate the brain responses to different interactions. Group analysis was performed using a random-effects model. A one-sample t-test was performed to compare the fMRI signal changes during manipulation vs. no manipulation within each treatment. Thresholds of p \< 0.005 were applied. Peak values of fMRI signal increase brain regions (insula) were used for the report below.
fMRI measures changes in brain activity by detecting fluctuations in blood oxygenation levels. The primary signal used in fMRI is the Blood Oxygen Level Dependent (BOLD) signal, which reflects neuronal activity indirectly through hemodynamic responses.
Outcome measures
| Measure |
Sham Acupuncture
n=25 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
VGAIT
n=23 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
VGAIT Control
n=26 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Real Acupuncture
n=24 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
|---|---|---|---|---|
|
fMRI Signal Increases
|
.33 beta value of bold signal
Standard Deviation .32
|
.42 beta value of bold signal
Standard Deviation .27
|
.48 beta value of bold signal
Standard Deviation .47
|
.47 beta value of bold signal
Standard Deviation .37
|
SECONDARY outcome
Timeframe: baseline and after one month treatmentPopulation: The functional connectivity analysis was performed using CONN toolbox. A threshold of p \< 0.005 was applied. We used peak brain regions showing significant functional connectivity increases after interventions to report (i.e. for VGAIT, insula was used; for VGAIT control, hippocampus was used; for verum acupuncture, insula was used; for sham acupuncture, prefrontal cortex was used). Please note this is NOT a result, rather a description on analysis details.
The resting state functional connectivity of periaqueduct grey (PAG) before and after intervention. Resting-state functional connectivity (rsFC) is assessed by analyzing spontaneous BOLD signal fluctuations in different brain regions when a subject is at rest, providing insights into intrinsic brain network organization. Preprocessing steps, including motion correction, spatial normalization, and noise removal, ensure data accuracy.
Outcome measures
| Measure |
Sham Acupuncture
n=25 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
VGAIT
n=22 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
VGAIT Control
n=25 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Real Acupuncture
n=21 Participants
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
|---|---|---|---|---|
|
PAG Resting State Connectivity
|
.08 normalized correlation coefficient
Standard Deviation .12
|
.09 normalized correlation coefficient
Standard Deviation .13
|
.09 normalized correlation coefficient
Standard Deviation .1
|
.1 normalized correlation coefficient
Standard Deviation .08
|
Adverse Events
VGAIT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VGAIT Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Real Acupuncture
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VGAIT
n=30 participants at risk
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
VGAIT Control
n=30 participants at risk
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Real Acupuncture
n=34 participants at risk
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
Sham Acupuncture
n=31 participants at risk
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ringing of ear
|
0.00%
0/30 • Through the whole interventions, average about one month.
|
0.00%
0/30 • Through the whole interventions, average about one month.
|
2.9%
1/34 • Number of events 1 • Through the whole interventions, average about one month.
|
0.00%
0/31 • Through the whole interventions, average about one month.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place