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Clinical observation of botulinum toxin injection combined with acupuncture in the treatment of cricopharyngeal achalasia after stroke

Clinical observation of botulinum toxin injection combined with acupuncture in the treatment of cricopharyngeal achalasia after stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070180
Enrollment
Unknown
Registered
2023-04-04
Start date
2023-04-05
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cricopharyngeal achalasia after stroke

Interventions

Control group:Simple basic medication and routine rehabilitation treatment
Botulinum toxin injection group:Implementing botulinum toxin injection therapy on the basis of basic medication and routine rehabilitation treatment
Acupuncture group:Implement acupuncture treatment based on basic medication and routine rehabilitation therapy
BTX+Acupuncture group:Implement botulinum toxin injection therapy combined with acupuncture treatment on the basis of basic medication and routine rehabilitation treatment

Sponsors

Wenzhou Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) age of 85 years old and below; (2) patients who met the diagnostic criteria of stroke in the "Diagnostic Points of Major Cerebrovascular Diseases in China 2019"; (3) first unilateral or bilateral cerebral hemisphere stroke confirmed by head CT or MRI; (4) conscious patients with stable vital signs; (5) There was no improvement in swallowing function after standard rehabilitation treatment for more than 2 weeks when the course of dysphagia was more than 1 month; (6) Functional oral intake Scale (FOIS) score = 2; (7) Cricopharyngeal achalasia symptoms such as cricopharyngeal stenosis or closed cricopharyngeal muscle were confirmed by videofluoroscopic swallowing examination (VFSS); (8) be able to understand and cooperate with the instructions of the treatment staff; (9) voluntarily participated in the study, cooperated with the examination and treatment, and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients were in the acute stage of unstable vital signs or severe chronic disease exacerbation; (2) patients with epilepsy history; (3) dysphagia caused by other neurogenic diseases; (4) with metal foreign bodies in the brain or heart, or wearing cardiac pacemaker, cochlear implant and other implants; (5) skin and soft tissue damage, infection, bleeding, rash and structural abnormalities in oral cavity, pharynx and esophagus; (6) patients with a history of allergy to botulinum toxin.

Design outcomes

Primary

MeasureTime frame
Functional oral food intake Scale;Standardized swallowing assessment;Swallowing-related quality of life;Video fuoroscopic swallowing study;Video fuoroscopic dysphagia scale;

Secondary

MeasureTime frame
Grading of drinking test;Self-rating anxiety scale;Self-rating depression scale;

Countries

China

Contacts

Public ContactDengchong Wu

Wenzhou Hospital of Traditional Chinese Medicine

15868751778@163.com15868751778

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026