Clinical trial NCT06874803: Acupuncture and Moxibustion for Motor Symptoms in Early Parkinson's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease (PD)
Keywords: Acupuncture
Moxibustion
Parkinson's Disease
Motor Symptoms
Rigidity
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Primary outcomes:
measure: The score change from baseline in the MDS-UPDRS part III after 8-week treatment
timeFrame: evaluation time points: baseline, week 8.
Secondary outcomes:
measure: The score change from baseline in the MDS-UPDRS part III after 8-week follow-up
timeFrame: evaluation time points: baseline, week 16.
measure: Changes in VAS scores of rigidity and bradykinesia after 8-week treatment and 8-week follow-up
timeFrame: evaluation time points: baseline, week 8, week 16.
measure: The score change from baseline in the MDS-UPDRS part II after 8-week treatment and 8-week follow-up
timeFrame: evaluation time points: baseline, week 8, week 16.
measure: The change from baseline in the MDS-UPDRS total score after 8-week treatment and 8-week follow-up
timeFrame: evaluation time points: baseline, week 8, week 16.
measure: The proportion of participants with ≥30% decrease of MDS-UPDRS Part III after 8-week treatment and 8-week follow-up
timeFrame: evaluation time points: baseline, week 8, week 16.
measure: The change from baseline in PDQ-39 after 8-week treatment and 8-week follow-up
timeFrame: evaluation time points: baseline, week 8, week 16.
measure: The change from baseline in PDSS after 8-week treatment and 8-week follow-up
timeFrame: evaluation time points: baseline, week 8, week 16.
measure: The change from baseline in SDS after 8-week treatment and 8-week follow-up
timeFrame: evaluation time points: baseline, week 8, week 16.
measure: The change from baseline in SAS after 8-week treatment and 8-week follow-up
timeFrame: evaluation time points: baseline, week 8, week 16.
measure: The change from baseline in functional MRI signals after 8-week treatment.
timeFrame: evaluation time points: baseline, week 8.
measure: Subgroup analysis of gender in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
timeFrame: evaluation time points: baseline, week 8.
measure: Subgroup analysis of age in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
timeFrame: evaluation time points: baseline, week 8.
measure: Subgroup analysis of disease severity in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
timeFrame: evaluation time points: baseline, week 8.
Other outcomes:
measure: The proportion of patients in intervention-related adverse events after 8-week treatment
timeFrame: evaluation time points: from baseline to the end of week 8.
measure: The proportion of patients with adherence ≥80%
timeFrame: evaluation time points: from baseline to the end of week 8.
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospita, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: