Clinical trial NCT06189560: Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia
Official title: A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dysphagia
Stellate Ganglion Block
Keywords: Stellate ganglion block
Pharyngeal Dysphagia
Stroke
Rehabilitation
Swallowing disorder
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 65
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Detailed description: Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Eligibility criteria: Inclusion Criteria:

* Age between 30 and 80 years;
* New-onset stroke, confirmed by head CT or MRI;
* The course of disease between 1 to 6 months;
* With pharyngeal dysphagia shown by VFSS;
* Stable vital signs;
* Voluntary participation in the study.

Exclusion Criteria:

* Allergy to Lidocaine injection or vitamin B12 injection;
* Severe cognitive impairment;
* Coagulation disorders;
* Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
* Complicated with other neurological diseases;
* With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points);
* Dysphagia caused by other diseases or reasons.

Primary outcomes:
measure: Video fluoroscopic swallowing study
timeFrame: day 1 and day 20
Secondary outcomes:
measure: Kubota water swallowing test
timeFrame: day 1 and day 20
measure: Rosenbek penetration-aspiration scale
timeFrame: day 1 and day 20
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng da yi fu yuan hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References:
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