Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome
- Conditions
- Interventions
- Registration Number
- NCT06370195
- Lead Sponsor
- Babujinaya Cela
- Brief Summary
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the s...
- Detailed Description
Palliation of dysphagia in patients with Parkinson's syndrome continues to be a challenge.
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Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- Stable vital signs, conscious, able to cooperate with assessment and treatment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comprehensive rehabilitation+Stellate ganglion block Comprehensive rehabilitation Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. Comprehensive rehabilitation+Stellate ganglion block Stellate ganglion block Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. Comparator: Comprehensive rehabilitation+placebo Comprehensive rehabilitation Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. Comparator: Comprehensive rehabilitation+placebo Placebo injection Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. Comprehensive rehabilitation+Stellate ganglion block Lidocaine hydrochloride Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
- Primary Outcome Measures
Name Time Method Drooling amount day 1 and day 10 All participants' saliva was collected within 5 minutes into a cup, followed by the comparison of saliva quantity, composition 1 hour before noon, the amount will be recorded.
- Secondary Outcome Measures
Name Time Method Modified Barthel Index day 1 and day 10 the activities of daily living of patients will be assessed using the modified Barthel Index . The scale includes 10 items such as feeding, bathing, walking, dressing. Each item is rated on a 4-point scale based on the level of assistance required, with a total score of 100 points. There is a positive correlation between activities of daily living and the fi...
Patient Health Questionnaire-9 day 1 and day 10 Patient Health Questionnaire-9 (PHQ-9) is a commonly used depression screening tool consisting of 9 items, designed to assess the severity of individual depressive symptoms. Each item is rated from 0 (not at all) to 3 (nearly every day) based on how the individual has been feeling over the past two weeks.
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