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

NCT06874803 | Recruiting

• 1 other identifier: HLCMHPP2023003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease (PD)

Keywords

Acupuncture; Moxibustion; Parkinson's Disease; Motor Symptoms; Rigidity

Outcome Measures

Primary Outcomes (1)

• The score change from baseline in the MDS-UPDRS part III after 8-week treatment

  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.

  evaluation time points: baseline, week 8.

Secondary Outcomes (13)

• 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.

Other Outcomes (2)

• The proportion of patients in intervention-related adverse events after 8-week treatment

  evaluation time points: from baseline to the end of week 8.

• The proportion of patients with adherence ≥80%

  evaluation time points: from baseline to the end of week 8.

Study Arms (2)

Acupuncture and Moxibustion Group (AM)

EXPERIMENTAL

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.

Procedure: Acupuncture and Moxibustion (AM)

Sham Acupuncture and Moxibustion Group (Sham-AM)

SHAM COMPARATOR

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.

Procedure: Sham Acupuncture and Moxibustion (Sham-AM)

Interventions

Acupuncture and Moxibustion (AM) PROCEDURE

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).

Acupuncture and Moxibustion Group (AM)

Sham Acupuncture and Moxibustion (Sham-AM) PROCEDURE

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).

Sham Acupuncture and Moxibustion Group (Sham-AM)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• \. Diagnosed with Parkinson's disease (PD) according to the 2016 Chinese 2. Diagnostic Criteria for Parkinson's Disease.
• \. Hoehn-Yahr stage \<3 (mild to moderate PD). 4. Age between 30 and 80 years (inclusive). 5. Signed informed consent indicating voluntary participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiani Wu: lead

Study Sites (1)

Guang'anmen Hospita, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Muscle Rigidity

Interventions

Acupuncture Therapy; Moxibustion

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Yu Liu, MD

CONTACT

8572650199; yliu133@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 13, 2025
• Study Start: August 1, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD will be available starting 6 months after publication of the primary results and will remain accessible for at least 5 years.
• Access Criteria: by email

Locations

CN (1)