Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

NCT ID: NCT05839535

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2028-08-31

Brief Summary

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This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical mechanism study
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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BDJ + real tDCS

Group Type ACTIVE_COMPARATOR

BDJ

Intervention Type BEHAVIORAL

BDJ is a mind-body intervention

tDCS

Intervention Type DEVICE

tDCS is a brain stimulation method.

Exercise + real tDCS

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

tDCS is a brain stimulation method.

exercise

Intervention Type OTHER

exercise including stretching and other activities.

BDJ + sham tDCS

Group Type ACTIVE_COMPARATOR

BDJ

Intervention Type BEHAVIORAL

BDJ is a mind-body intervention

sham tDCS

Intervention Type DEVICE

sham tDCS

Exercise + sham tDCS

Group Type ACTIVE_COMPARATOR

sham tDCS

Intervention Type DEVICE

sham tDCS

exercise

Intervention Type OTHER

exercise including stretching and other activities.

Interventions

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BDJ

BDJ is a mind-body intervention

Intervention Type BEHAVIORAL

tDCS

tDCS is a brain stimulation method.

Intervention Type DEVICE

sham tDCS

sham tDCS

Intervention Type DEVICE

exercise

exercise including stretching and other activities.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteers 45-75 years of age
* Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months;
* Physically able to participate in the BDJ and stretching control education programs
* Willing to complete the 12-week study
* Can participate in MRI scan
* Ability to read and understand English; English can be a second language provided that the patient feels he or she can understand all the questions used in the assessment measures

Exclusion Criteria

* Has performed BDJ, Tai Chi, Yoga, other mind-body intervention, physical therapy, or routine exercise (running, cycling, etc.) regularly in the past year
* Serious medical conditions limiting ability of patient to participate in the study, such as symptomatic cardiovascular disease, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease
* Has had intra-articular steroid injections or reconstructive surgery in the prior 3 months on the affected knee; any intra-articular hyaluronic acid injections in the previous 6 months
* Patient Mini-Mental Status Examination score below 24 \[293\]
* Unable to walk without a cane or other assistive device
* The intent to undergo surgery during the time of involvement in the study
* Plan to permanently relocate from the region during the trial period
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 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

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jian Kong

Role: CONTACT

617-7267893

Facility Contacts

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meixuan Zhu

Role: primary

617-726-5004

Other Identifiers

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2023P000908

Identifier Type: -

Identifier Source: org_study_id

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