Recruiting
Phase 2

Baduanjin

Sponsor:

Massachusetts General Hospital

Code:

NCT05839535

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

BDJ

tDCS

sham tDCS

exercise

Study Details

Brief summary:

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.

Conditions

Knee Osteoarthritis

Study ID

NCT05839535

Start date

Mar 5, 2024

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: BDJ + real tDCS

active comparator: Exercise + real tDCS

active comparator: BDJ + sham tDCS

active comparator: Exercise + sham tDCS

Interventions

BDJ

BDJ is a mind-body intervention

tDCS

tDCS is a brain stimulation method.

sham tDCS

sham tDCS

exercise

exercise including stretching and other activities.

Primary outcome measure

  • M1 resting state functional connectivity [ Time Frame: Baseline, post-treatment (12 weeks) ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-17.