- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261505
Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
November 30, 2023 updated by: Jian Kong, Massachusetts General Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jian Kong, MD, MPH
- Phone Number: 617-726-7893
- Email: jkong2@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Charlestown, Massachusetts, United States, 02129
- Athinoula A. Martinos Center for Biomedical Imaging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VGAIT
|
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other Names:
|
Sham Comparator: VGAIT Control
|
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other Names:
|
Active Comparator: Real Acupuncture
|
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other Names:
|
Placebo Comparator: Sham Acupuncture
|
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fMRI signal increases
Time Frame: 4 days; Sessions 2-5
|
4 days; Sessions 2-5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2019
Primary Completion (Actual)
August 29, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
August 22, 2017
First Submitted That Met QC Criteria
August 24, 2017
First Posted (Actual)
August 25, 2017
Study Record Updates
Last Update Posted (Estimated)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P000820
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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