NCT05839535招募中2 期
Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- M1 resting state functional connectivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BDJ + sham tDCS
Active Comparator
干预措施: sham tDCS (Device)
Exercise + sham tDCS
Active Comparator
干预措施: sham tDCS (Device)
Exercise + sham tDCS
Active Comparator
干预措施: exercise (Other)
BDJ + real tDCS
Active Comparator
干预措施: BDJ (Behavioral)
BDJ + real tDCS
Active Comparator
干预措施: tDCS (Device)
Exercise + real tDCS
Active Comparator
干预措施: tDCS (Device)
Exercise + real tDCS
Active Comparator
干预措施: exercise (Other)
BDJ + sham tDCS
Active Comparator
干预措施: BDJ (Behavioral)
结局指标
主要结局
M1 resting state functional connectivity
时间窗: Baseline, post-treatment (12 weeks)
Changes in brain resting-state connectivity between the primary motor cortex (M1) and other brain regions pre- and post-treatments, analyzed using the CONN Toolbox (https://web.conn-toolbox.org/)
次要结局
- Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline, post-treatment (12 weeks), follow-up (24 weeks))
- Change on Cerebral blood flow(Baseline, post-treatment (12 weeks))
- Change on M1 corticospinal excitability and cortico-cortical excitability(Baseline, post-treatment (12 weeks))
- Change on 6-Minute Walk Test(Baseline, post-treatment (12 weeks), follow-up (24 weeks))
- Change on Pain Catastrophizing Scale (PCS)(Baseline, post-treatment (12 weeks), follow-up (24 weeks))
- Change on Quantitative Sensory Testing (QST)(Baseline, post-treatment (12 weeks), follow-up (24 weeks))
- Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29(Baseline, post-treatment (12 weeks), follow-up (24 weeks))
- change on Beck's Depression Inventory (BDI-II)(Baseline, post-treatment (12 weeks), follow-up (24 weeks))
- Change on brain gray matter volume(Baseline, post-treatment (12 weeks))
研究者
Jian Kong
Principal investigator
Massachusetts General Hospital
研究点 (1)
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