DysphagiaNCT06335316

Effect of Stellate Nerve Block in Dysphagia

A study testing Injection, Lidocaine Hydrochloride and Comprehensive therapy in people with Dysphagia, run by Copka Sonpashan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysphagia
What is being tested?: Injection, Lidocaine Hydrochloride and Comprehensive therapy
Type of treatment: Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 1 siteTaiwan
Study dates: 1 Jan 2022to 28 May 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
Dysphagia.
Age >18 years.
First-time stroke.
Steady vital signs,
Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

Who cannot join

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;
Dysphagia caused by other diseases or reasons.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Huimin Hos.
Pengfu

Other trials in Taiwan

About this study

Official title: Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke

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 China. 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,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Read the detailed description

Dysphagia is a frequent and potentially serious complication of stroke. 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 China. 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,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Conditions: Dysphagia
Being tested: Injection, Lidocaine Hydrochloride, Comprehensive therapy, placebo
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InjectionProcedure or surgery
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.
Lidocaine HydrochlorideDrug
the patients were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
Comprehensive therapyBehavioural
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.).
placeboBehavioural
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. Only normal saline was used

Study groups in NCT06335316
Study group	Role	What they receive
Stellate Nerve Block+ routine rehabilitation treatment	Experimental	The patients were given Nerve block and routine rehabilitation treatment for 10 days. Receives: Procedure: Injection; Drug: Lidocaine Hydrochloride; Behavioral: Comprehensive therapy
placebo+routine rehabilitation treatment	Placebo comparator	The patients were given placebo block and routine rehabilitation treatment for 10 days. Receives: Behavioral: Comprehensive therapy; Behavioral: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional Oral Intake Scale
The Functional Oral Intake Scale (FOIS) is a tool used to assess the level of independence in oral intake for individuals with swallowing difficulties. The scale ranges from Level 1 to Level 7, with higher Levels indicating better swallowing function.
Measured: day 1 and day 10

Secondary outcomes (3)

Yale Pharyngeal Residue Severity Rating Scale
The Yale Pharyngeal Residue Severity Rating Scale (Yale) was used to assess the severity of pharyngeal residue in patients. While PAS primarily evaluated whether food or liquid entered the airway, Yale focused on the condition of pharyngeal residue. The scale includes the four levels from 0 to 3, with lower levels indicating less severe pharyngeal residue.
Measured: day 1 and day 10
penetration-aspiration scale
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.
Measured: day 1 and day 10
The Swallowing Quality of Life Questionnaire
The Swallowing Quality of Life Questionnaire (SWAL-QOL) is a tool designed to assess how swallowing difficulties impact an individual's quality of life. The questionnaire covers various aspects such as eating, speech, and social interaction to understand the challenges and effects of swallowing disorders on daily life.
SWAL-QOL scores can range from 0 to 100, with higher scores indicating a better quality of life related to swallowing function. Therefore, a higher SWAL-QOL score reflects less negative impact of swallowing difficulties on an individual's overall quality of life, highlighting better adaptation to and management of swallowing issues.
Measured: day 1 and day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202228 May 2023

First posted28 Mar 2024
Study start1 Jan 2022
Primary completion4 May 2023
Study completion28 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DysphagiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06335316
Sponsor's protocol ID: wallenburg sym
Status last verified: Mar 2024
First submitted: 22 Mar 2024
Last updated: 28 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
ClinicalTrials.gov ID: NCT06335316
Acronym / sponsor ID: wallenburg sym
Conditions: Dysphagia
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Copka SonpashanOther government
Study start: 1 Jan 2022 (actual)
Primary completion: 4 May 2023 (actual)
Study completion: 28 May 2023 (actual)
First posted: 28 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Stellate Nerve Block+ routine rehabilitation treatment	Experimental	Procedure: Injection, Drug: Lidocaine Hydrochloride, Behavioral: Comprehensive therapyThe patients were given Nerve block and routine rehabilitation treatment for 10 days.
placebo+routine rehabilitation treatment	Placebo comparator	Behavioral: Comprehensive therapy, Behavioral: placeboThe patients were given placebo block and routine rehabilitation treatment for 10 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
Dysphagia.
Age >18 years.
First-time stroke.
Steady vital signs,

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InjectionThe 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 or surgery	Stellate Nerve Block+ routine rehabilitation treatment
Lidocaine Hydrochloridethe patients were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)	Drug	Stellate Nerve Block+ routine rehabilitation treatment
Comprehensive therapyAll 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.).	Behavioural	Stellate Nerve Block+ routine rehabilitation treatment, placebo+routine rehabilitation treatment
placeboThe 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. Only normal saline was used	Behavioural	placebo+routine rehabilitation treatment

Primary outcome

Functional Oral Intake Scale
Time frame: day 1 and day 10
The Functional Oral Intake Scale (FOIS) is a tool used to assess the level of independence in oral intake for individuals with swallowing difficulties. The scale ranges from Level 1 to Level 7, with higher Levels indicating better swallowing function.

3 secondary outcomes

Yale Pharyngeal Residue Severity Rating Scale
Time frame: day 1 and day 10
penetration-aspiration scale
Time frame: day 1 and day 10
The Swallowing Quality of Life Questionnaire
Time frame: day 1 and day 10

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.

Related trials for Dysphagia

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
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Not yet recruitingPhase 2
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Active, not recruitingObservational study
RETHINK REFLUX Registry
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nieto Luis, Master study chair

Site Coordinator of United Medical Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Injection, Lidocaine Hydrochloride and Comprehensive therapy in people with Dysphagia, run by Copka Sonpashan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Oral Intake Scale (time frame: day 1 and day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06335316.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.