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

NCT ID: NCT03261505

Last Updated: 2025-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-04

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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VGAIT

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

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

VGAIT Control

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type DEVICE

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

Real Acupuncture

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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

Sham Acupuncture

Group Type PLACEBO_COMPARATOR

Acupuncture

Intervention Type DEVICE

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

Interventions

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Acupuncture

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

Intervention Type DEVICE

Other Intervention Names

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Video of Acupuncture

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Kong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Athinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017P000820

Identifier Type: -

Identifier Source: org_study_id

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