Efficacy of Stellate Ganglion Block in Children With Cerebral Palsy and Dysphagia

NCT ID: NCT06211426

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-04-30

Brief Summary

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Detailed Description

Cerebral palsy is a common non-progressive clinical condition characterized by motor disorders and abnormal postures, which significantly impact the quality of life of affected children. Swallowing dysfunction is a common complication in children with Cerebral palsy , affecting their daily eating and communication skills, and hindering their nutritional development and social interaction. Stellate ganglion block has shown certain efficacy in improving swallowing function in children with Cerebral palsy. However, there is limited research on the effects of stellate ganglion block treatment on swallowing dysfunction in children with Cerebral palsy. Therefore, this study aims to explore this topic and provide scientific evidence for its clinical application.

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

the experimental group

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.The experimental group was given Stellate Ganglion Block.

Group Type: EXPERIMENTAL

routine rehabilitation treatment

Intervention Type: BEHAVIORAL

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time.

Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time.

Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time.

Direct feeding training: with powdered milk, once a day, 5 days a week.

Stellate ganglion block

Intervention Type: PROCEDURE

The patients were provided with Stellate ganglion block , using 0.5ml 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.

the control group

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.

Group Type: ACTIVE_COMPARATOR

routine rehabilitation treatment

Intervention Type: BEHAVIORAL

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time.

Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time.

Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time.

Direct feeding training: with powdered milk, once a day, 5 days a week.

Interventions

routine rehabilitation treatment

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time.

Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time.

Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time.

Direct feeding training: with powdered milk, once a day, 5 days a week.

Intervention Type: BEHAVIORAL

Stellate ganglion block

The patients were provided with Stellate ganglion block , using 0.5ml 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
• age between 4 to 7 years;
• diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;

Exclusion Criteria

• with dysphagia caused by other diseases or factors;
• with progressive neurological disease or degenerative neurological disease;
• with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
• with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
• with poor compliance.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeng Changhao

OTHER

Sponsor Role: lead

Responsible Party

Zeng Changhao

Head of R&D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis, Master

Role: PRINCIPAL_INVESTIGATOR

Site Coordinator of United Medical Group located in Miami

Locations

Zheng da yi fu yuan hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

2023-KY-1031

Identifier Type: -

Identifier Source: org_study_id