Clinical trial NCT06255756: Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients
Official title: Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dysphagia
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.

Detailed description: We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.

The study lasted 42 days (6 weeks) for each participant. Specifically, our main focus is on the study of Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng, Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible), Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).

Eligibility criteria: Inclusion Criteria:

* Age \>18 years.
* Meeting the diagnostic criteria for Parkinson's disease.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Water swallow test\> Level 3.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* History of mental diseases or use of antipsychotics.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: Penetration-Aspiration Scale-liquid
timeFrame: Day 1 and Day 42
measure: Penetration-Aspiration Scale-paste
timeFrame: Day 1 and Day 42
Secondary outcomes:
measure: Swallowing time
timeFrame: Day 1 and Day 42
measure: body mass index
timeFrame: Day 1 and Day 42
measure: Serum Albumin
timeFrame: Day 1 and Day 42
measure: Prealbumin
timeFrame: Day 1 and Day 42
measure: Hemoglobin
timeFrame: Day 1 and Day 42
measure: Swallowing Quality of Life
timeFrame: Day 1 and Day 42
Other outcomes:
Locations:
city: Zhenzhou
country: China
facility: Zheng Da yi Yuan Hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: