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Recruiting NCT06874803

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

No phase Interventional Parkinson's Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupuncture and Moxibustion (AM), Sham Acupuncture and Moxibustion (Sham-AM).
Who it may be relevant to
Registry conditions: Parkinson's Disease (PD). Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure Acupuncture and Moxibustion (AM)
    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).
  • Procedure Sham Acupuncture and Moxibustion (Sham-AM)
    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).

Primary outcome measures

  • The score change from baseline in the MDS-UPDRS part III after 8-week treatment [Time frame: evaluation time points: baseline, week 8.]
Secondary outcome measures (12)
  • The score change from baseline in the MDS-UPDRS part III after 8-week follow-up [Time frame: evaluation time points: baseline, week 16.]
  • Changes in VAS scores of rigidity and bradykinesia after 8-week treatment and 8-week follow-up [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in PDQ-39 after 8-week treatment and 8-week follow-up [Time frame: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in PDSS after 8-week treatment and 8-week follow-up [Time frame: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in SDS after 8-week treatment and 8-week follow-up [Time frame: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in SAS after 8-week treatment and 8-week follow-up [Time frame: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in functional MRI signals after 8-week treatment. [Time frame: 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 [Time frame: 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 [Time frame: evaluation time points: baseline, week 8.]

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:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Guang'anmen Hospita, China Academy of Chinese Medical Sciences — Beijing

Identifiers

NCT: NCT06874803 · HLCMHPP2023003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗