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Trial record 48 of 1171 for:    acupuncture

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

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ClinicalTrials.gov Identifier: NCT03261505
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

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 Phase
Osteoarthritis, Knee Device: Acupuncture Not Applicable

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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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
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

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

Locations
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United States, Massachusetts
Athinoula A. Martinos Center for Biomedical Imaging Recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital

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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: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases