Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia

Not Applicable

Terminated

• Conditions: Stellate Ganglion Block; Dysphagia
• Interventions: Behavioral: comprehensive rehabilitation; Drug: SGB

• Registration Number: NCT06189560
• Lead Sponsor: Zeng Changhao

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.

Study Timeline

• Study Start: 2022-06-21
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-17
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The observation group	SGB	Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.
The observation group	comprehensive rehabilitation	Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.
The control group	comprehensive rehabilitation	Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.

Primary Outcome Measures

Name	Time	Method
Video fluoroscopic swallowing study	day 1 and day 20	The patient was required to take a sitting position with the head naturally upright. Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms). If the patient exhibited aspiration, the test would stop. If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety. Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase. The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase. The total score was calculated as the final result. The final score was positively correlated with the swallowing function.

Secondary Outcome Measures

Name	Time	Method
Rosenbek penetration-aspiration scale	day 1 and day 20	Based on VFSS, this assessment evaluated the patient's swallowing of contrast medium and whether there was retention, penetration, and aspiration. It included multiple items, each with the corresponding criteria, Specifically, whether the swallowed material entered the airway, passed through or contacted the vocal cords, and whether the patient exhibited the corresponding ability to clear. There were 8 levels in the results, with higher levels indicating more severe aspiration.
Kubota water swallowing test	day 1 and day 20	During the test, patients were required to drink 30 ml of warm water. According to the situation, the swallowing function was rated from Level 1 (excellent) to Level 5 (poor). Specifically, Grade 1: The patient drank all the water at once without choking; Grade II: The patient drank all the water in two or more times without choking; Grade III: The patient drank all the water at once with choking; Grade IV: The patient drank all the water in two or more times with choking; Grade V: The patient exhibited difficulty drinking with frequent choking. Besides, we evaluated the efficacy as: 1) Recovery: The patient's symptoms of dysphagia disappear with grade 1 in the test. 2) Improvement: The patient shows improvement in dysphagia with the water the grade of the test improved. 3) Invalid: The patient's dysphagia deteriorates or did not improve, with the grade of the test not improved. (Overall effective rate = Recovery rate + Improvement rate).

Trial Locations

Locations (1)

Zheng da yi fu yuan hospital; 🇨🇳 Zhengzhou, Henan, China