We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03261505
Recruitment Status : Not yet recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Device: Acupuncture

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
Anticipated Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: VGAIT Device: Acupuncture
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other Name: Video of Acupuncture
Sham Comparator: VGAIT Control Device: Acupuncture
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other Name: Video of Acupuncture
Active Comparator: Real Acupuncture Device: Acupuncture
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other Name: Video of Acupuncture
Placebo Comparator: Sham Acupuncture Device: Acupuncture
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Other Name: Video of Acupuncture


Outcome Measures

Primary Outcome Measures :
  1. fMRI signal increases [ Time Frame: 4 days; Sessions 2-5 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261505


Contacts
Contact: Jian Kong, MD, MPH 617-726-7893 jkong2@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
More Information

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03261505     History of Changes
Other Study ID Numbers: 2017P000820
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jian Kong, Massachusetts General Hospital:
fMRI
acupuncture
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases