NCT03261505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 4, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 5, 2025

Completed
Last Updated

November 5, 2025

Status Verified

October 1, 2025

Enrollment Period

4.1 years

First QC Date

August 22, 2017

Results QC Date

December 8, 2023

Last Update Submit

October 21, 2025

Conditions

Keywords

fMRIacupunctureosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • PAG Resting State Connectivity

    baseline and after one month treatment

Study Arms (4)

VGAIT

EXPERIMENTAL
Device: Acupuncture

VGAIT Control

SHAM COMPARATOR
Device: Acupuncture

Real Acupuncture

ACTIVE COMPARATOR
Device: Acupuncture

Sham Acupuncture

PLACEBO COMPARATOR
Device: Acupuncture

Interventions

Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.

Also known as: Video of Acupuncture
Real AcupunctureSham AcupunctureVGAITVGAIT Control

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right-handed
  • Knee osteoarthritis patients
  • Ages 40 to 70 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Prof. Jian Kong
Organization
Massachusetts General Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 25, 2017

Study Start

August 4, 2019

Primary Completion

August 29, 2023

Study Completion

August 31, 2023

Last Updated

November 5, 2025

Results First Posted

November 5, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations