Acupuncture and Moxibustion for Motor Symptoms in Early Parkinson's Disease

Title: 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

This study evaluates the clinical effect and safety of the "Qi-Tonifying, Yang-Warming, and Water-Resolving" acupuncture method in improving motor symptoms of 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.

Design: Prospective, randomized, parallel-controlled trial with a 1:1 ratio between the two groups. The patients, efficacy evaluators, and statistical analysts will be blinded. A total of 90 patients will be included.

This study is a randomized, triple-blind (patients, efficacy evaluators, and statistical analysts), controlled trial conducted at Guang'anmen Hospital, China Academy of Chinese Medical Sciences, with a 1:1 allocation ratio between two groups. Ninety (90) participants diagnosed with early-stage PD (Hoehn-Yahr stage \<3) will be randomly assigned to one of the following groups:

Intervention Group: Acupuncture treatment will be administered based on standard western medication treatment. Acupuncture and moxibustion group (AM): Acupuncture at Shuifen (CV9), bilateral Yinlingquan (SP9), bilateral Zhongliao (BL33), and bilateral Weiyang (BL39), combined with moxibustion at Shuifen (CV9) and Zhongliao (BL33). Sham acupuncture and moxibustion group (sham-AM): Acupuncture at non-acuipoints of bilateral Hegu (LI4) and bilateral Zusanli (ST36), with fake moxibustion at Shuifen (CV9) and bilateral Zhongliao (BL33).

Participants will receive 3 treatments per week for 8 weeks (total: 24 sessions), followed by an 8-week follow-up period.

Primary Outcome: Change in MDS-UPDRS Part III (motor symptoms) score from baseline to week 8. Secondary Outcomes: Changes in MDS-UPDRS part 3 score after follow-up compared to baseline. Change in VAS scores for rigidity and bradykinesia、MDS-UPDRS part 2 (non-motor symptoms) score, total MDS-UPDRS score, PDQ-39, PDSS, SAS, SDS after treatment and follow-up. Percentage of patients showing a 30% reduction in MDS-UPDRS part 3 score after 8 weeks of treatment and follow-up. Change in functional brain imaging signals (partial patients) after treatment and follow-up.

This study will help explore whether acupuncture and moxibustion can serve as a safe and effective complementary therapy for managing motor symptoms in early PD and the potential brain mechanisms underlying this effect.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria:

1. Diagnosed with Parkinson's disease (PD) according to the 2016 Chinese 2. Diagnostic Criteria for Parkinson's Disease.

3. Hoehn-Yahr stage \<3 (mild to moderate PD). 4. Age between 30 and 80 years (inclusive). 5. Signed informed consent indicating voluntary participation.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

1. Diagnosed with Parkinson-plus syndromes or other secondary parkinsonism.
2. Prior history of deep brain stimulation (DBS) surgery.
3. Severe cerebrovascular disease, brain trauma, or history of craniotomy.
4. Severe dementia or psychiatric disorders that prevent cooperation with study procedures.
5. Severe coagulation disorders.
6. Presence of severe systemic organ dysfunction (cardiac, pulmonary, hepatic, renal, endocrine, or metabolic disorders).
7. Pregnant or breastfeeding women.
8. History of allergic reaction to acupuncture or moxibustion.
9. Prior treatment with Chinese medicine (herbal medicine, proprietary Chinese medicine, or acupuncture) for Parkinson's disease within the past three months.

Participation in another clinical trial within the past three months.