Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion

Dysphagia Clinical Trial

Official title:

Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03524703
• Other study ID #: GDREC 2018151H
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2018
• Source: Guangdong General Hospital
• Contact: Yunbing Chang, M.D., Ph.D.
• Phone: 86-020-83827812
• Email: cspine[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to estimate the effect of chewing gum after anterior cervical fusion surgery on decreasing the severity of dysphagia in patients with mild-moderate dysphagia.

Description:

Postoperative dysphagia is the most common complication of anterior cervical fusion surgery. Previous studies showed that chewing gum helped to improve swallow frequency and latency. However, its short-term effect on alleviating dysphagia symptom after anterior cervical surgery is still unknown. A randomized, parallel controlled, superiority trial is performed in patients with postoperative mild-moderate dysphagia. Dysphagia severity will be assessed using dysphagia short questionnaire (DSQ) score in the chewing gum group and control group during 7 days after surgery, and the changes in DSQ score between two groups will be compared, to estimate the effect of chewing gum on alleviating dysphagia symptom.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age from 18 years to 80 years.

• underwent anterior cervical fusion surgery for degenerative cervical disease.

• diagnosed with mild or moderate postoperative dysphagia 1 day after surgery using Bazaz scale.

Exclusion Criteria:

• Patients underwent revision procedures or procedures treating conditions other than degenerative cervical disease.

• Patients with preoperative dysphagia.

• Patients unable to chew, or unable to follow the directions for chewing gum.

• Patients unable to attend follow-up visits or finish the dysphagia questionnaires.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Other:
• chewing gum
Chewing gum four times per day for 5 days, 15 minutes each time.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia Short Questionnaire (DSQ) score	DSQ is designed for the evaluation of swallowing difficulty after anterior cervical spine surgery. It is calculated by summing up the points given for each item, from 0 point to a maximum of 18 points, where lower scores represent milder symptoms and vice versa.	Change from the 1st day after surgery to the 7th day after surgery.
Secondary	Bazaz grading system	Bazaz grading system is designed for the evaluation of swallowing difficulty after anterior cervical spine surgery. The patients are graded as having none, mild, moderate, or severe dysphagia based on their symptoms. A none or mild dysphagia is considered to be a better outcome.	Change from the 1st day after surgery to the 7th day after surgery.
Secondary	Prevertebral soft tissue swelling	The measurement of the soft tissue space is made on the line parallel to the upper end plate from the midpoint of the anterior surface of each vertebral body to the border of the airway shadow. This scale ranges from 0 to approximately 30 mm for each vertebra, where a lower value represents a milder soft tissue swelling.	The 3rd days after surgery.