Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	45 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05839535
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massachusetts General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis

Arms & Interventions

Arms

Active Comparator: BDJ + real tDCS

Active Comparator: Exercise + real tDCS

Active Comparator: BDJ + sham tDCS

Active Comparator: Exercise + sham tDCS

Interventions

Behavioral: - BDJ

BDJ is a mind-body intervention

Device: - tDCS

tDCS is a brain stimulation method.

Device: - sham tDCS

sham tDCS

Other: - exercise

exercise including stretching and other activities.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Charlestown, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Charlestown, Massachusetts, 02129

Site Contact

meixuan Zhu

[email protected]

617-726-5004

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