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Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05713968
Enrollment
50
Registered
2023-02-06
Start date
2023-01-27
Completion date
2029-12-31
Last updated
2023-02-06

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

Conditions

Upper Esophageal Sphincter Relaxing Pressure

Brief summary

patients with cervical spondylolysis may have swallowing or eating difficulty. In this study, we will use high resolution impedance manometry to evaluate these patients' detailed swallowing mechanisms.

Detailed description

This study will aim to evaluate swallowing function in patients with cervical spondylolysis by using high resolution impedance manometry (HRIM) along with oral frailty and dysphagia questionnaires. Researchers will plan to enroll 50 patients to investigate this issue. The inclusion criteria will be as following:1) age higher or equal to 20 years old; 2) patients with cervical spondylolysis or associated symptoms. The exclusion criteria will be as following: major organ dysfunction, including chronic kidney disease, bleeding tendency. The primary outcome will be the upper esophageal sphincter relaxing pressure. The researchers will hope to find the swallowing dysfunction mechanisms in these patients.

Interventions

OTHERpatients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM

patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM

OTHERpatients with EAT-10 lower than 3 or frailty questionnaire lower than 2

patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 examined by HRIM

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with cervical spondylosis associated symptoms or expected to undergo cervical spine surgery * patients with associated swallowing difficulty symptoms

Exclusion criteria

* major organ dysfunction, such as renal insufficiency or bleeding tendency

Design outcomes

Primary

MeasureTime frameDescription
upper esophageal sphincter pressure30 minutesupper esophageal sphincter opening ability questionnaire

Contacts

Primary ContactChih-Jun Lai, MD
littlecherrytw@gmail.com+886223123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026