Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
All Genders
ID06304285

A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis: a Single-center, Randomized, Double-blind Study

Led by The First Affiliated Hospital of University of Science and Technology of China · Updated on 2024-03-12

84

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Parkinson's disease (PD) is a condition where symptoms worsen over time, and medications may become less effective, significantly lowering patients' quality of life. Recent findings suggest a close link between PD symptoms and intestinal health, especially in patients with chronic appendicitis. Acupuncture targeting points related to constipation and chronic appendicitis has shown promise in improving both motor and non-motor symptoms of PD, such as anxiety, depression, sleep disturbances, and cognitive dysfunction. This study aims to further understand acupuncture's role in treating PD comprehensively, particularly focusing on intestinal acupuncture. Participants in this randomized, double-blind trial will receive acupuncture treatment at specific points including Tianshu, Zusanli, Hegu, Taichong, Shangjuxu, Jigou, Zhaohai, Lanwei, and Shousanli. The interventions involve comfort needle and comfort embedding needle techniques. The study compares an experimental acupuncture group with a control group receiving sham acupuncture, where the needle only touches the skin without penetration. Treatment schedules and methods are designed to assess acupuncture's effects on PD symptoms in patients with chronic appendicitis. During the study, participants will be evaluated using the MDS Unified Parkinson's Disease Rating Scale III over three months to measure motor symptom changes. Researchers will monitor symptom improvements and adverse events while ensuring participants maintain stable anti-PD medication if used. The trial includes informed consent, clinical examinations, imaging for appendicitis confirmation, and other assessments to ensure safety and data accuracy. The total participation spans the treatment and follow-up periods up to the study's end in 2026.

CONDITIONS

Brief Title

A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis

Who Can Participate

Age: 40Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients showing bradykinesia with resting tremor and/or muscle stiffness
  • Chronic appendicitis confirmed by appendix CT evaluated by two experts
  • Signed informed consent from patients and their guardians
  • Normal blood clotting function
  • Stable use of oral anti-Parkinson's drugs for at least 2 weeks before enrollment
Not Eligible

You will not qualify if you...

  • Use of dopamine blockers or depleters causing drug-induced parkinsonism
  • Normal presynaptic dopaminergic system on neuroimaging
  • Severe brain trauma or complex brain surgery within past 5 years
  • Diagnosed with cognitive disorders outside Parkinson's spectrum (e.g., Alzheimer's, frontotemporal dementia)
  • Severe neuropsychiatric disorders like epilepsy, bipolar disorder, major depression per DSM-V
  • Serious systemic diseases such as stroke, coronary heart disease, diabetes, liver/kidney diseases, or severe sensory disorders
  • Severe swallowing difficulties
  • Inability to complete study visits or examinations as required

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive either acupuncture treatment or sham acupuncture treatment targeting specific acupoints.

Multiple visits during treatment period

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China, 230001

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Research Team

Y

Yuhua Chen, M.M.S.

C

Chao Han, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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