Bulbar PalsyNCT06347250
A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia
A study testing Nerve Block, Lidocaine Hydrochloride and routine therapy in people with Bulbar Palsy, run by Babujinaya Cela at 1 site in China.
Trial summary
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bulbar Palsy
- What is being tested?
- Nerve Block, Lidocaine Hydrochloride and routine therapy
- Type of treatment
- 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 siteChina
- Study dates
- 1 Jan 2022to 31 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.
- Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
- 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.
About this study
Official title: A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia: A Randomized Controlled Study
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. 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 Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
Read the 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 or the control group. 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 Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
- Conditions
- Bulbar Palsy
- Being tested
- Nerve Block, Lidocaine Hydrochloride, routine therapy, placebo block
- Medical subject headings
- Bulbar Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve BlockProcedure 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).
routine 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.).
Regrading swallowing function training, both groups are given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic／isometric swallowing exercises, supraglottic swallowing exercises, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day.
placebo blockProcedure or surgery
the patients were provided with normal saline. 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.
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | The patients were given Nerve block and routine therapy for 10 days. Receives: Procedure: Nerve Block; Drug: Lidocaine Hydrochloride; Behavioral: routine therapy |
| placebo | Placebo comparator | The patients were given placebo block and routine therapy for 10 days. Receives: Behavioral: routine therapy; Procedure: placebo block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 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 (4)
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
Video fluoroscopic swallowing study
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.
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.
- First posted4 Apr 2024
- Study start1 Jan 2022
- Primary completion2 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulbar PalsyStudies 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)
Sponsor and investigators
- Lead sponsor
- Babujinaya Cela
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Babujinaya Cela, Buraidah Central Hospital
- Investigators
- Nieto Luis, Master, Study director, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347250
- Sponsor's protocol ID
- SGB-Bulbar Palsy
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06347250
- Acronym / sponsor ID
- SGB-Bulbar Palsy
- Conditions
- Bulbar Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Babujinaya CelaOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 4 Apr 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.
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. 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 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 or the control group. 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 Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
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 |
|---|---|---|
| Nerve block | Experimental | Procedure: Nerve Block, Drug: Lidocaine Hydrochloride, Behavioral: routine therapyThe patients were given Nerve block and routine therapy for 10 days. |
| placebo | Placebo comparator | Behavioral: routine therapy, Procedure: placebo blockThe patients were given placebo block and routine therapy 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.
- Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
- 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 |
|---|---|---|
| Nerve BlockThe 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 | Nerve block |
| 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 | Nerve block |
| routine 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.). Regrading swallowing function training, both groups are given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic／isometric swallowing exercises, supraglottic swallowing exercises, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day. | Behavioural | Nerve block, placebo |
| placebo blockthe patients were provided with normal saline. 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. | Procedure or surgery | placebo |
Primary outcome
The 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.
4 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
Video fluoroscopic swallowing study
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 4 Apr 2024.
Related trials for Bulbar Palsy
RecruitingObservational study
ALS/MND Natural History Study Data Repository
ALS, PLS
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 director
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 Nerve Block, Lidocaine Hydrochloride and routine therapy in people with Bulbar Palsy, run by Babujinaya Cela at 1 site in China.
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 4 Apr 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 China. 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?
The 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?
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 4 Apr 2024.