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Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain

Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03261505
Enrollment
125
Registered
2017-08-25
Start date
2019-08-04
Completion date
2023-08-31
Last updated
2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

fMRI, acupuncture, osteoarthritis

Brief summary

The aim of this study is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture.

Interventions

DEVICEAcupuncture

Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Right-handed * Knee osteoarthritis patients * Ages 40 to 70 years old

Exclusion criteria

* Any contraindications to MRI scanning (claustrophobia, metal implants) * Current or past history of major medical, neurological, or psychiatric illness other than knee osteoarthritis (including high blood pressure, heart disorders, impaired elimination, stomach problems, major kidney or liver problems, bleeding problems, severe dehydration, history of diabetes, history of asthma or other respiratory condition) * Pregnancy * Non fluent English speaker

Design outcomes

Primary

MeasureTime frameDescription
fMRI Signal IncreasesCollected once during the first treatment sessionfMRI 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.

Secondary

MeasureTime frameDescription
PAG Resting State Connectivitybaseline and after one month treatmentThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
VGAIT
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
30
VGAIT Control
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
30
Real Acupuncture
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
34
Sham Acupuncture
Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
31
Total125

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyClaustrophobic or can not provide proof of diagnosis0020
Overall Studythe subject can not concentrate to complete the questionnaire1000
Overall Studyunrelated surgery preventing the subject participating the study0010
Overall StudyWithdrawal by Subject2343

Baseline characteristics

CharacteristicVGAIT ControlReal AcupunctureSham AcupunctureVGAITTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants10 Participants9 Participants11 Participants36 Participants
Age, Categorical
Between 18 and 65 years
24 Participants24 Participants22 Participants19 Participants89 Participants
Age, Continuous59.7 year
STANDARD_DEVIATION 7.8
59.7 year
STANDARD_DEVIATION 7.6
61.6 year
STANDARD_DEVIATION 7.4
61.5 year
STANDARD_DEVIATION 8.2
60.6 year
STANDARD_DEVIATION 7.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants1 Participants1 Participants4 Participants
Race (NIH/OMB)
Black or African American
1 Participants5 Participants3 Participants3 Participants12 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
27 Participants27 Participants26 Participants26 Participants106 Participants
Region of Enrollment
United States
30 participants34 participants31 participants30 participants125 participants
Sex: Female, Male
Female
20 Participants22 Participants20 Participants17 Participants79 Participants
Sex: Female, Male
Male
10 Participants12 Participants11 Participants13 Participants46 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 300 / 340 / 31
other
Total, other adverse events
0 / 300 / 301 / 340 / 31
serious
Total, serious adverse events
0 / 300 / 300 / 340 / 31

Outcome results

Primary

fMRI Signal Increases

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.

Time frame: Collected once during the first treatment session

Population: 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.

ArmMeasureValue (MEAN)Dispersion
VGAITfMRI Signal Increases.42 beta value of bold signalStandard Deviation 0.27
VGAIT ControlfMRI Signal Increases.48 beta value of bold signalStandard Deviation 0.47
Real AcupuncturefMRI Signal Increases.47 beta value of bold signalStandard Deviation 0.37
Sham AcupuncturefMRI Signal Increases.33 beta value of bold signalStandard Deviation 0.32
Secondary

PAG Resting State Connectivity

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.

Time frame: baseline and after one month treatment

Population: 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.

ArmMeasureValue (MEAN)Dispersion
VGAITPAG Resting State Connectivity.09 normalized correlation coefficientStandard Deviation 0.13
VGAIT ControlPAG Resting State Connectivity.09 normalized correlation coefficientStandard Deviation 0.1
Real AcupuncturePAG Resting State Connectivity.1 normalized correlation coefficientStandard Deviation 0.08
Sham AcupuncturePAG Resting State Connectivity.08 normalized correlation coefficientStandard Deviation 0.12

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026