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

March 4, 2024 updated by: The First Affiliated Hospital of University of Science and Technology of China

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

The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients presenting with bradykinesia, combined with resting tremor and/or myotonia.
  • Appendix CT suggested chronic appendicitis evaluated by two experienced experts.
  • All subjects and their guardians give informed consent to the content of this study and sign informed consent.
  • Normal coagulation function.
  • If the patient had taken oral anti-PD drugs, it had been stable for at least 2 weeks at enrollment.

Exclusion Criteria:

  • Treatment with dopamine blockers or dopamine depleters in doses and time courses consistent with drug-induced parkinsonism.
  • Neuroimaging examination of presynaptic dopaminergic system function was normal.
  • Patients who had suffered severe brain trauma or underwent complex craniotomy within 5 years prior to enrollment.
  • Cognitive disorders that are not on the Parkinson's spectrum, such as Alzheimer's disease, frontotemporal dementia, and Niemann-Pick disease, have been diagnosed.
  • People diagnosed with severe neuropsychiatric disorders (epilepsy, bipolar disorder, major depressive episode, etc.) according to DSM-V.
  • Complicated with serious systemic diseases, disorders of consciousness, stroke, serious coronary heart disease, diabetes, liver and kidney diseases, and serious visual and hearing disorders.
  • Patients with severe organic or functional dysphagia;Those who were deemed by the researcher to be unable to complete the visit and auxiliary examination as required by the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture group
The subjects received acupuncture treatment at the following points: Tianshu, Zusanli, Hegu, Taichong, Shangjuxu, Jigou, Zhaohai, Lanwei and shousanli.
Other: Acupuncture treatment
Acupuncture was performed according to the corresponding acupoint of the patient
Sham Comparator: control group
Treatment with comfort needle and comfort embedding needle
Other: Sham acupuncture treatment
The needle only touches the patient's skin and does not penetrate the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of MDS Unified-Parkinson Disease Rating Scale III
Time Frame: 3 month
The changes of MDS-UPDRS III scores before and after acupuncture treatment were compared.The lowest score was 0 and the highest was 132, with higher scores indicating more severe symptoms.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Yuhua Chen, M.M.S., The First Affiliated Hospital of University of Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-ky421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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