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临床试验 NCT05839535 针对膝骨关节炎目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA
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临床试验NCT05839535旨在研究其他，主要针对膝骨关节炎。这是一项II期 (第二期) 干预性研究试验，目前试验状态为招募中。试验始于2024年3月5日，计划招募140名患者。该研究由Massachusetts General Hospital主导，预计于2028年8月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年5月7日。
简要概括
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.
官方标题
Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis
疾病
膝骨关节炎其他研究标识符
- 2023P000908
NCT编号
实际开始日期
2024-03-05
最近更新发布
2025-05-07
预计完成日期
2028-08-31
计划入组人数
140
研究类型
干预性研究
试验分期 (阶段)
II期 (第二期)
试验状态
招募中
主要目的
其他
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照BDJ + real tDCS | BDJ BDJ is a mind-body intervention 经颅直流电刺激 (tDCS) tDCS is a brain stimulation method. |
阳性对照Exercise + real tDCS | 经颅直流电刺激 (tDCS) tDCS is a brain stimulation method. 锻炼 exercise including stretching and other activities. |
阳性对照BDJ + sham tDCS | BDJ BDJ is a mind-body intervention 假经颅直流电刺激（TDCS） sham tDCS |
阳性对照Exercise + sham tDCS | 假经颅直流电刺激（TDCS） sham tDCS 锻炼 exercise including stretching and other activities. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
M1 resting state functional connectivity | 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/) | Baseline, post-treatment (12 weeks) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change on Cerebral blood flow | Cerebral blood flow will be measured using arterial spin labeling (ASL) | Baseline, post-treatment (12 weeks) |
Change on M1 corticospinal excitability and cortico-cortical excitability | M1 corticospinal excitability will be measured using motor threshold, motor evoked potential, short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF). | Baseline, post-treatment (12 weeks) |
Change on brain gray matter volume | Voxel-based morphometry (VBM) analysis will be performed to investigate gray matter volume changes. | Baseline, post-treatment (12 weeks) |
Change on Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS is a 35-item self-administered survey of pain and function in knee OA patients. | Baseline, post-treatment (12 weeks), follow-up (24 weeks) |
Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | We will use PROMIS-29 to assess pain, function, depression, anxiety, and sleep in the past 7 days. | Baseline, post-treatment (12 weeks), follow-up (24 weeks) |
change on Beck's Depression Inventory (BDI-II) | BDI-II is designed for individuals aged 13 and over and is composed of items relating to symptoms of depression. | Baseline, post-treatment (12 weeks), follow-up (24 weeks) |
Change on Pain Catastrophizing Scale (PCS) | PCS is a 15-item questionnaire used to characterize an individual's tendency to magnify the threat value of a pain experience and to feel helpless in the presence of pain. | Baseline, post-treatment (12 weeks), follow-up (24 weeks) |
Change on Quantitative Sensory Testing (QST) | Pressure pain thresholds will be assessed 3 times using a Somedic digital pressure algometer. Contact heat stimuli will be delivered using a PATHWAY CHEPS (Contact Heat-Evoked Potential Stimulator, Medoc Advanced Medical Systems). | Baseline, post-treatment (12 weeks), follow-up (24 weeks) |
Change on 6-Minute Walk Test | The 6-Minute Walk Test is a self-paced endurance test that assesses walking ability and endurance and includes standardized encouragement that increase tolerability in elders and those with physical impairment. | Baseline, post-treatment (12 weeks), follow-up (24 weeks) |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
45 Years
适龄性别
全部
- 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
- 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
Massachusetts General Hospital研究责任方
Jian Kong, 主要研究者, Principal investigator, Massachusetts General Hospital
研究中心联系人
联系人: Jian Kong, 617-7267893, [email protected]
1 位于 1 个国家/地区的研究中心
Massachusetts
Massachusetts General Hospital, Charlestown, Massachusetts, 02129, United States
meixuan Zhu, 联系人, 617-726-5004, [email protected]
招募中