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

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis, Knee focused on measuring fMRI, acupuncture, osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Athinoula A. Martinos Center for Biomedical ImagingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Active Comparator

Placebo Comparator

Arm Label

VGAIT

VGAIT Control

Real Acupuncture

Sham Acupuncture

Arm Description

Outcomes

Primary Outcome Measures

fMRI signal increases

Secondary Outcome Measures

Full Information

First Posted
August 22, 2017
Last Updated
December 29, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03261505
Brief Title
Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
Official Title
Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
fMRI, acupuncture, osteoarthritis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VGAIT
Arm Type
Experimental
Arm Title
VGAIT Control
Arm Type
Sham Comparator
Arm Title
Real Acupuncture
Arm Type
Active Comparator
Arm Title
Sham Acupuncture
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Video of Acupuncture
Intervention Description
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
Primary Outcome Measure Information:
Title
fMRI signal increases
Time Frame
4 days; Sessions 2-5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Kong, MD, MPH
Phone
617-726-7893
Email
jkong2@mgh.harvard.edu
Facility Information:
Facility Name
Athinoula A. Martinos Center for Biomedical Imaging
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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