Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VGAIT | Experimental |
| |
| VGAIT Control | Sham Comparator |
| |
| Real Acupuncture | Active Comparator |
| |
| Sham Acupuncture | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Collected once during the first treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athinoula A. Martinos Center for Biomedical Imaging | Charlestown | Massachusetts | 02129 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | VGAIT | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| FG001 | VGAIT Control | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| FG002 | Real Acupuncture | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| FG003 | Sham Acupuncture | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VGAIT | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| BG001 | VGAIT Control | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | beta value of bold signal | Collected once during the first treatment session |
|
Through the whole interventions, average about one month.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VGAIT | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ringing of ear | Ear and labyrinth disorders | Systematic Assessment | The subject experienced ear ring after MRI. It is not related to acupuncture treatment as the subject did not receive acupuncture treatment yet. The subject recovered without treatment. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Jian Kong | Massachusetts General Hospital | 16179620978 | kongj@nmr.mgh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2023 | Oct 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2023 | Oct 20, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| baseline and after one month treatment |
| unrelated surgery preventing the subject participating the study |
|
| Claustrophobic or can not provide proof of diagnosis |
|
| the subject can not concentrate to complete the questionnaire |
|
| BG002 | Real Acupuncture | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| BG003 | Sham Acupuncture | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | VGAIT Control | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| OG002 | Real Acupuncture | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
| OG003 | Sham Acupuncture | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | normalized correlation coefficient | baseline and after one month treatment |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | VGAIT Control | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Real Acupuncture | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. | 0 | 34 | 0 | 34 | 1 | 34 |
| EG003 | Sham Acupuncture | Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. | 0 | 31 | 0 | 31 | 0 | 31 |
|
Not provided
Not provided