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Clinical Trials/NCT06301724
NCT06301724
Not yet recruiting
Not Applicable

A Randomized Double-blind Trial to Explore Effectiveness of Stellate Ganglion Block in Individuals With Parkinson's Disease

Muhammad0 sites80 target enrollmentMarch 2024

Overview

Phase
Not Applicable
Intervention
Injection
Conditions
Parkinson Disease
Sponsor
Muhammad
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.

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Muhammad
Responsible Party
Sponsor Investigator
Principal Investigator

Muhammad

Research Director

Ahmadu Bello University Teaching 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

the patients 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: Injection

Stellate ganglion block

the patients 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

Injection

the patients were provided with injection, which was with the same procedure of stellate ganglion block but no drugs.

Intervention: 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)

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