Effectiveness of Stellate Ganglion Block in Patients Diagnosed With Parkinson's Disease: A Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Rehabilitation therapy
- Conditions
- Parkinson Disease
- Sponsor
- Copka Sonpashan
- Enrollment
- 80
- Primary Endpoint
- Penetration-Aspiration Scale
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:
• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.
Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.
Detailed Description
Dysphagia, or swallowing difficulty, is a common symptom associated with Parkinson's disease. It is characterized by weakened chewing and throat muscles, leading to difficulties in eating, coughing, and a sensation of choking in individuals with Parkinson's disease. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are: • Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease. Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.
Investigators
Copka Sonpashan
Research Director
Chao Phya Abhaibhubejhr Hospital
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
- •Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- •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.
Arms & Interventions
Stellate ganglion block+Rehabilitation therapy
The study lasted 10d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided. Based on the invention above, the patients in the observation group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
Intervention: Rehabilitation therapy
Stellate ganglion block+Rehabilitation therapy
The study lasted 10d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided. Based on the invention above, the patients in the observation group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
Intervention: Stellate ganglion block
Stellate ganglion block+Rehabilitation therapy
The study lasted 10d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided. Based on the invention above, the patients in the observation group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
Intervention: Lidocaine hydrochloride
Rehabilitation therapy+placebo block
The study lasted 10d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.
Intervention: Rehabilitation therapy
Rehabilitation therapy+placebo block
The study lasted 10d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.
Intervention: Placebo injection
Outcomes
Primary Outcomes
Penetration-Aspiration Scale
Time Frame: day 1 and day 10
Penetration-Aspiration Scale is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases.The scores rang from 0 to 8
Secondary Outcomes
- Modified Barthel Index(day 1 and day 10)
- Functional Oral Intake Scale(day 1 and day 10)