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

Jiani Wu

Status: Enrolling

Conditions: Parkinson's Disease (PD)

Treatments: Procedure: Sham Acupuncture and Moxibustion (Sham-AM); Procedure: Acupuncture and Moxibustion (AM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06874803

HLCMHPP2023003

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

2. 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 acupuncture or moxibustion within the past three months.
10. Participation in another clinical trial within the past three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Acupuncture and Moxibustion Group (AM)

Experimental group

Description:

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.

Treatment:

Procedure: Acupuncture and Moxibustion (AM)

Sham Acupuncture and Moxibustion Group (Sham-AM)

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham Acupuncture and Moxibustion (Sham-AM)