NCT05839535 Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA
| NCT ID | NCT05839535 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2024-03-05 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05839535 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05839535 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05839535 currently recruiting?
Yes, NCT05839535 is actively recruiting participants. Contact the research team at jkong2@mgh.harvard.edu for enrollment information.
Where is the NCT05839535 trial being conducted?
This trial is being conducted at Charlestown, United States.
Who is sponsoring the NCT05839535 clinical trial?
NCT05839535 is sponsored by Massachusetts General Hospital. The trial plans to enroll 140 participants.