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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06304285
• Other study ID #: 2023-ky421
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital of University of Science and Technology of China
• Contact: Yuhua Chen, M.M.S.
• Phone: +8615955236270
• Email: yh1215[@]mail.ustc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Appendicitis
• Chronic Appendicitis
• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Acupuncture treatment
Acupuncture was performed according to the corresponding acupoint of the patient
• Sham acupuncture treatment
The needle only touches the patient's skin and does not penetrate the skin

Locations

Country	Name	City	State
China	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of University of Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of MDS Unified-Parkinson Disease Rating Scale III	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