Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome

Parkinson's Syndrome Clinical Trial

Official title:

Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370195
• Other study ID #: SGB-Liuxian
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Buraidah Central Hospital
• Contact: Laviena Ce
• Phone: 15422548954
• Email: linchuangzhuce[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.

Description:

Palliation of dysphagia in patients with Parkinson's syndrome continues to be a challenge.

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 stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• 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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Syndrome
• Sialorrhea
• Syndrome

Intervention

Behavioral:
• Comprehensive rehabilitation
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.

Procedure:
• Stellate ganglion block
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). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

Drug:
• Lidocaine hydrochloride
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). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

Procedure:
• Placebo injection
1 milliliter of normal saline will be used for injection. The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Babujinaya Cela

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drooling amount	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.	day 1 and day 10
Secondary	Modified Barthel Index	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 final score.	day 1 and day 10
Secondary	Patient Health Questionnaire-9	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.; The total score ranges from 0 to 27, and the severity of depressive symptoms is assessed as follows: 0-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20 and above: Severe depression When assessing the severity of depressive symptoms, a higher total score indicates more severe symptoms, while a lower total score indicates milder symptoms.	day 1 and day 10