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

NCT ID: NCT06304285

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Parkinson's Disease Chronic Appendicitis Acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acupuncture group

The subjects received acupuncture treatment at the following points: Tianshu, Zusanli, Hegu, Taichong, Shangjuxu, Jigou, Zhaohai, Lanwei and shousanli.

Group Type EXPERIMENTAL

Acupuncture treatment

Intervention Type OTHER

Acupuncture was performed according to the corresponding acupoint of the patient

control group

Treatment with comfort needle and comfort embedding needle

Group Type SHAM_COMPARATOR

Sham acupuncture treatment

Intervention Type OTHER

The needle only touches the patient's skin and does not penetrate the skin

Interventions

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Acupuncture treatment

Acupuncture was performed according to the corresponding acupoint of the patient

Intervention Type OTHER

Sham acupuncture treatment

The needle only touches the patient's skin and does not penetrate the skin

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuhua Chen, M.M.S.

Role: STUDY_CHAIR

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

Locations

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

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuhua Chen, M.M.S.

Role: CONTACT

+8615955236270

Chao Han, M.D.

Role: CONTACT

+8615255629713

Facility Contacts

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Yuhua Chen, M.M.S.

Role: primary

+8615955236270

Chao Han, M.D.

Role: backup

+8615255629713

Other Identifiers

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2023-ky421

Identifier Type: -

Identifier Source: org_study_id

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