Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

Mass General Brigham

Status and phase: Enrolling; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Device: tDCS; Device: sham tDCS; Behavioral: BDJ; Other: exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05839535

2023P000908

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups

BDJ + real tDCS

Active Comparator group

Treatment:

Behavioral: BDJ

Device: tDCS

Exercise + real tDCS

Active Comparator group

Treatment:

Other: exercise

Device: tDCS

BDJ + sham tDCS

Active Comparator group

Treatment:

Device: sham tDCS

Behavioral: BDJ

Exercise + sham tDCS

Active Comparator group

Treatment:

Other: exercise

Device: sham tDCS