Clinical trial NCT06304285: A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis
Official title: A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis: a Single-center, Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Chronic Appendicitis
Acupuncture
Keywords: Parkinson's disease
acupuncture
Lead sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Score of MDS Unified-Parkinson Disease Rating Scale III
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of University of Science and Technology of China
name: Yuhua Chen, M.M.S.
role: STUDY_CHAIR
References: