Effect of "Qi-Tonifying, Yang-Warming, and Water-Resolving" Acupuncture and Moxibustion for Motor Symptom Improvement in Early Parkinson's Disease (WARMED): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The score change from baseline in the MDS-UPDRS part III after 8-week treatment
研究概览
简要总结
This study evaluates the clinical effect and safety of acupuncture combined with moxibustion in improving motor symptoms of early-stage Parkinson's Disease (PD) patients, by assessing the changes in UPDRS scores. It also explores objective factors affecting the acupuncture effect and investigates the functional MRI mechanisms of acupuncture in PD treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be unaware of whether they are receiving real or sham acupuncture and moxibustion.
The treating practitioners will follow the same protocol across both groups but will remain blinded to the randomization.
Outcome assessors and statisticians will be blinded to the group assignments during data collection and analysis.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Diagnosed with Parkinson's disease (PD) according to the 2016 Chinese
- •Diagnostic Criteria for Parkinson's Disease.
- •Hoehn-Yahr stage <3 (mild to moderate PD).
- •Age between 30 and 80 years (inclusive).
- •Signed informed consent indicating voluntary participation.
排除标准
- •Participants meeting any of the following criteria will be excluded:
- •Diagnosed with Parkinson-plus syndromes or other secondary parkinsonism.
- •Prior history of deep brain stimulation (DBS) surgery.
- •Severe cerebrovascular disease, brain trauma, or history of craniotomy.
- •Severe dementia or psychiatric disorders that prevent cooperation with study procedures.
- •Severe coagulation disorders.
- •Presence of severe systemic organ dysfunction (cardiac, pulmonary, hepatic, renal, endocrine, or metabolic disorders).
- •Pregnant or breastfeeding women.
- •History of allergic reaction to acupuncture or moxibustion.
- •Prior treatment with acupuncture or moxibustion within the past three months.
- •Participation in another clinical trial within the past three months.
研究组 & 干预措施
Acupuncture and Moxibustion Group (AM)
Participants in this group will receive acupuncture and moxibustion therapy alongside standard Parkinson's disease (PD) medication. Acupuncture at Shuifen (CV9), bilateral Yinlingquan (SP9), bilateral Zhongliao (BL33), and bilateral Weiyang (BL39), combined with moxibustion at Shuifen (CV9) and Zhongliao (BL33). Each participant will undergo treatment three times per week for eight weeks (24 total sessions). Standard PD medication will remain unchanged throughout the study.
干预措施: Acupuncture and Moxibustion (AM) (Procedure)
Sham Acupuncture and Moxibustion Group (Sham-AM)
Participants in this group will receive sham acupuncture and sham moxibustion alongside standard PD medication. Acupuncture at non-acuipoints of bilateral Hegu (LI4) and bilateral Zusanli (ST36), with fake moxibustion at Shuifen (CV9) and bilateral Zhongliao (BL33). Treatments will be conducted three times per week for eight weeks (24 total sessions). Standard PD medication will remain unchanged.
干预措施: Sham Acupuncture and Moxibustion (Sham-AM) (Procedure)
结局指标
主要结局
The score change from baseline in the MDS-UPDRS part III after 8-week treatment
时间窗: evaluation time points: baseline, week 8.
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
次要结局
- The score change from baseline in the MDS-UPDRS part III after 8-week follow-up(evaluation time points: baseline, week 16.)
- Changes in VAS scores of rigidity and bradykinesia after 8-week treatment and 8-week follow-up(evaluation time points: baseline, week 8, week 16.)
- The score change from baseline in the MDS-UPDRS part II after 8-week treatment and 8-week follow-up(evaluation time points: baseline, week 8, week 16.)
- The change from baseline in the MDS-UPDRS total score after 8-week treatment and 8-week follow-up(evaluation time points: baseline, week 8, week 16.)
- The proportion of participants with ≥30% decrease of MDS-UPDRS Part III after 8-week treatment and 8-week follow-up(evaluation time points: baseline, week 8, week 16.)
- The change from baseline in PDQ-39 after 8-week treatment and 8-week follow-up(evaluation time points: baseline, week 8, week 16.)
- The change from baseline in PDSS after 8-week treatment and 8-week follow-up(evaluation time points: baseline, week 8, week 16.)
- The change from baseline in SDS after 8-week treatment and 8-week follow-up(evaluation time points: baseline, week 8, week 16.)
- The change from baseline in SAS after 8-week treatment and 8-week follow-up(evaluation time points: baseline, week 8, week 16.)
- The change from baseline in functional MRI signals after 8-week treatment.(evaluation time points: baseline, week 8.)
- Subgroup analysis of gender in the score change from baseline in the MDS-UPDRS part III after 8-week treatment(evaluation time points: baseline, week 8.)
- Subgroup analysis of age in the score change from baseline in the MDS-UPDRS part III after 8-week treatment(evaluation time points: baseline, week 8.)
- Subgroup analysis of disease severity in the score change from baseline in the MDS-UPDRS part III after 8-week treatment(evaluation time points: baseline, week 8.)
研究者
Jiani Wu
Associate Chief Physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences