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Recruiting NCT06304285

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

No phase Interventional Parkinson's Disease Chronic Appendicitis Acupuncture

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 treatment, Sham acupuncture treatment.
Who it may be relevant to
Registry conditions: Parkinson's Disease, Chronic Appendicitis, Acupuncture. Basic parameters: 40 years — 70 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 →
Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Score of MDS Unified-Parkinson Disease Rating Scale III [Time frame: 3 month]

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.

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
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of University of Science and Technology of China — Hefei

Identifiers

NCT: NCT06304285 · 2023-ky421

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗