Clinical trial NCT05839535: Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA
Official title: Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 140
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical mechanism study
Primary purpose: OTHER

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

Primary outcomes:
measure: M1 resting state functional connectivity
timeFrame: Baseline, post-treatment (12 weeks)
Secondary outcomes:
measure: Change on Cerebral blood flow
timeFrame: Baseline, post-treatment (12 weeks)
measure: Change on M1 corticospinal excitability and cortico-cortical excitability
timeFrame: Baseline, post-treatment (12 weeks)
measure: Change on brain gray matter volume
timeFrame: Baseline, post-treatment (12 weeks)
measure: Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
measure: Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29
timeFrame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
measure: change on Beck's Depression Inventory (BDI-II)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
measure: Change on Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
measure: Change on Quantitative Sensory Testing (QST)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
measure: Change on 6-Minute Walk Test
timeFrame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: