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

NCT06304285 | Recruiting

• 1 other identifier: 2023-ky421
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson's Disease; Chronic Appendicitis; Acupuncture

Keywords

Parkinson's disease; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Other: Acupuncture treatment

control group

SHAM COMPARATOR

Treatment with comfort needle and comfort embedding needle

Other: Sham acupuncture treatment

Interventions

Acupuncture treatment OTHER

Acupuncture was performed according to the corresponding acupoint of the patient

Acupuncture group

Sham acupuncture treatment OTHER

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

control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China: lead

Study Sites (1)

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

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yuhua Chen, M.M.S.

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

  STUDY CHAIR

Central Study Contacts

Yuhua Chen, M.M.S.

CONTACT

+8615955236270; yh1215@mail.ustc.edu.cn

Chao Han, M.D.

CONTACT

+8615255629713; 15255629713@193.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)