Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. 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, video fluoroscopic swallowing study, ultrasound diagnostic devices, and penetration-aspiration scale, Flexible laryngoscope are used to assess swallowing function.
Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge.This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. 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, video fluoroscopic swallowing study, and penetration-aspiration scale, ultrasound diagnostic devices, Flexible laryngoscope are used to assess swallowing function.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive rehabilitation+Stellate ganglion block | Experimental | 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+placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive rehabilitation | Behavioral | All the participants are provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.). |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Barium Swallow Impairment Profile | The Modified Barium Swallow Impairment Profile is used to evaluate the clinical severity of dysphagia. It consisted of 17 items. The total scores could range between 0 and 55, with higher scores indicating worse function. | day 1 before any intervention, day 11, and day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Murray secretion severity scale | Murray secretion severity scale is used for assessment of Pharyngeal secretion. The result was divided into 0-3 levels (0, normal; 1, a small amount of secretion remained and not entering the laryngeal vestibule; 2: temporary accumulation in the laryngeal vestibule; 3: persistent accumulation in the laryngeal vestibule. A higher score indicates the worse dysphagia. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nieto Luis | Site Coordinator of United Medical Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| zhongshan affiliated No.1 Hospital | Guandong | China | ||||
| HLJ older people hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41782152 | Derived | Zeng H, Zhang W, Yang Y, Li Y, Wang S, Fang L, Wen C, Zhao W, Li D, Luo S, Zeng J, Wang X, Luo P, Li H, Wang L, Wang C, Zeng X. Effects of ultrasound-guided stellate ganglion block in poststroke bulbar palsy: a double-blind placebo-controlled trial. BMC Med. 2026 Mar 4;24(1):225. doi: 10.1186/s12916-026-04684-4. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010244 | Bulbar Palsy, Progressive |
| ID | Term |
|---|---|
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Stellate ganglion block | Procedure | 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. The ultrasonic instrument is used to determine the position. |
|
| Lidocaine Hydrochloride | Drug | the patients are provided with Stellate ganglion block, using 2.8ml of 0.8% Lidocaine hydrochloride and 0.2 ml of 0.5% vitamin B12. 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. The ultrasonic instrument is used to determine the position. |
|
| placebo injection | Behavioral | 2.8 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. The ultrasonic instrument is used to determine the position. |
|
| day 1 before any intervention, day 11, and day 60 |
| Yale pharyngeal residue severity rating scale | The Yale pharyngeal residue severity rating scale was recruited for assessment of Pharyngeal residue.The result would be divided into 5 levels (1, no residue; 2, the covered pharyngeal mucosa; 3, mild residue, less than 50%; 4, moderate residue, more than 50%; 5, severe residue, spillage from laryngeal vestibule observed). A higher score indicates the worse dysphagia. | day 1 before any intervention, day 11, and day 60 |
| Penetration-Aspiration Scale | Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased. | day 1 before any intervention, day 11, and day 60 |
| Generalized Anxiety Disorder 7-item scale | Generalized Anxiety Disorder 7-item scale was used to assess anxiety.The total score could range from 0 to 21, with higher scores indicating more severe anxiety. | day 1 before any intervention, day 11, and day 60 |
| Movement distances of the hyoid bone | The lateral swallowing fluorography record was decomposed into individual images. Images were selected at both the resting positions and the maximum displacement. The distance of position change for the hyoid bone between the two images was measured with the inferior border of the C4 vertebra as a reference point. Then, the average movement distance was calculated and adopted. | day 1 before any intervention, day 11, and day 60 |
| Vertebral artery cerebral blood flow velocity | The ultrasound diagnostic device was used to measure the internal diameter of the vertebral artery. The sample volume was then positioned at the center of the vessel and the angle between the ultrasound beam and the blood flow direction was kept within 60°. The Color Doppler ultrasound examination was performed to measure the mean blood flow velocity of the vertebral artery by continuously observing 10 cycles. | day 1 before any intervention, day 11, and day 60 |
| Vertebral artery internal diameter | The ultrasound diagnostic device was used to measure the internal diameter of the vertebral artery. The sample volume was then positioned at the center of the vessel and the angle between the ultrasound beam and the blood flow direction was kept within 60°. | day 1 before any intervention, day 11, and day 60 |
| Heilongjiang |
| China |
| Lankao Renmen Hospital | Henan | China |
| NY zhongxin Hospital | Naning | China |
| People's Hospital of SN tequ | Suzhu | China |
| Department of rehabilitation medicine, the first ZU hospital north campus | Zhenzhou | China |
| Aniline Compounds |
| D000588 | Amines |