Clinical trial NCT06199323: Acupuncture Therapy on Dysphagia in Parkinson's Disease
Official title: Acupuncture Therapy on Dysphagia in Parkinson's Disease: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: From June 2019 to May 2021, we conducted a randomized controlled study, including dysphagic patients with Parkinson's diseases who were admitted to the department of rehabilitation medicine in 3 hospitals in China. The participants were divided randomly into the experimental group and the control group, with 56 in each one. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.

Detailed description: From June 2019 to May 2021, we conducted a randomized controlled study, including dysphagic patients with Parkinson's diseases who were admitted to the department of rehabilitation medicine in 3 hospitals in China. The participants were divided randomly into the experimental group and the control group, with 56 in each one. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy. 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 developed by the Neurology Branch of the Chinese Medical Association in 2006.
* 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-The oral transit time-liquid
timeFrame: day 1 and day 42
measure: Swallowing time-The oral transit time-paste
timeFrame: day 1 and day 42
measure: Swallowing time-swallowing reaction time-liquid
timeFrame: day 1 and day 42
measure: Swallowing time-pharyngeal transit time -liquid
timeFrame: day 1 and day 42
measure: Swallowing time-laryngeal closure duration-liquid
timeFrame: day 1 and day 42
measure: Swallowing time-swallowing reaction time-paste
timeFrame: day 1 and day 42
measure: Swallowing time-pharyngeal transit time-paste
timeFrame: day 1 and day 42
measure: Swallowing time-laryngeal closure duration-paste
timeFrame: day 1 and day 42
measure: Nutritional status-body mass index
timeFrame: day 1 and day 42
measure: Nutritional status-Serum Albumin
timeFrame: day 1 and day 42
measure: Nutritional status-Prealbumin
timeFrame: day 1 and day 42
measure: Nutritional status-Hemoglobin
timeFrame: day 1 and day 42
measure: Standardized Swallowing Assessment
timeFrame: day 1 and day 42
Other outcomes:
Locations:
city: Pingdong
country: Taiwan
facility: Quanmi Hos.
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: