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Clinical observation on the Treatment of Parkinson's Disease Related Fatigue with Fatigue three-needle

Clinical observation on the Treatment of Parkinson's Disease Related Fatigue with Fatigue three-needle

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002504
Enrollment
Unknown
Registered
2025-12-24
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Fatigue three-needle acupuncture group:Basic treatment combined with Fatigue three-needle acupuncture
Placebo-acupuncture group:Basic treatment combined with placebo-acupuncture

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Gender is not limited, and the age is between 35 and 75 years old; (2) It meets the PDRF diagnostic criteria issued by MDS in 2016; (3) The modified Hoehn Yahr rating scale was rated 1-3; (4) After dividing the total score of fatigue severity scale by 9, the final score is>4; (5) At present, the dosage of anti Parkinson's disease drug stabilizer is taken regularly for 1 month; (6) Normal mind, behavior coordination, clear language, and can correctly express the sense of acupuncture; (7) Good compliance, able to complete the test according to the requirements of the treatment plan, including those who can receive acupuncture treatment, follow-up visits and follow-up visits on time; (8) Voluntarily participate in the study and sign the informed consent. Only those who meet the above 8 requirements can be included.

Exclusion criteria

Exclusion criteria: (1) Identify other serious systemic diseases, such as immune system diseases, endocrine system diseases (such as pheochromocytoma, hyperthyroidism, etc.), respiratory system diseases, cardiovascular and cerebrovascular diseases, or liver and kidney dysfunction; (2) Identify other diseases that can lead to Parkinson's syndrome or are suspected to be related to the patient's symptoms, such as Parkinson's syndrome, senile tremor, etc; (3) There were clear cerebellar ataxia or cerebellar eye movement abnormalities; (4) There were clear cortical compound sensory loss and motor apraxia of limb concepts or progressive aphasia; (5) Downward vertical supranuclear gaze paralysis or downward vertical saccade selective slowing; (6) Parkinson's like symptoms were still confined to the lower extremities 3 years after onset; (7) The patients were diagnosed with highly suspected behavioral variant frontotemporal dementia or primary progressive aphasia within 5 years after onset; (8) There was no significant response to high-dose levodopa treatment; (9) Myocardial infarction, cerebrovascular accident, severe trauma or major operation within half a year; (10) Those with a clear history of mental illness or accompanied by psychotic symptoms, such as depression, schizophrenia, etc; (11) Those who are unable to express independently and have intellectual and language barriers; (12) Have a history of abuse of certain substances (such as alcohol, drugs, caffeine) or a history of taking sleeping pills and psychotropic substances in the past six months; (13) Participating in other clinical trials such as drugs, acupuncture and moxibustion within 1 month before being included in the study; (14) Pregnant or lactating women, or those who are fertile and unwilling/unable to take effective contraceptive measures; (15) Afraid of acupuncture or suspicious of acupuncture; (16) Allergic constitution, or acupuncture contraindications, such as drunkenness, high fever, or skin diseases such as inflammation, erosion, exudation, ulcer, scar, serious injury, infection, edema, etc. at the acupoints selected for this test; (17) In the past, needle syncope, pneumothorax and spontaneous bleeding caused by acupuncture were not suitable for acupuncture; (18) Fatigue caused by drugs and other reasons; (19) The researcher believes that it does not meet other conditions included. If any of the above items is met, it will be excluded.

Design outcomes

Primary

MeasureTime frame
Score of Multidimensional Fatigue Inventory.;

Secondary

MeasureTime frame
Score of Fatigue Severity Scale.;Score of Parkinson fatigue scale.;Score of Unified Parkinson's Disease Rating Scale.;Score of Parkinson's Patient Quality of Life Questionnaire.;Blood Plasma IL-1ß content;Blood Plasma IL-18 content;Blood Plasma TNF-a content;Blood Plasma a-syn content;Blood Plasma p-a-syn content;

Countries

People's Republic of China

Contacts

Public ContactLi-xing Zhuang

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

zhuanglixing@163.com13822287775

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026