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

Primary Purpose

Dysphagia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
chewing gum
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring dysphagia, anterior cervical fusion, chewing gum

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chewing Gum Group

Control Group

Arm Description

Patients who receive anterior cervical fusion and have mild or moderate dysphagia postoperatively, will be randomized into two groups. Subjects assigned to the Chewing Gum Group are asked to chew gum four times a day for 5 days (15 minutes each time) after surgery in addition to standard cares. Standard cares include cleaning the wound every 2 days, wearing a collar, pain management, and education.

Patients who receive anterior cervical fusion and have mild or moderate dysphagia postoperatively, will be randomized into two groups. Subjects assigned to the Control Group receive standard cares and are asked not to chew gum within 5 days after surgery. Standard cares include cleaning the wound every 2 days, wearing a collar, pain management, and education.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 11, 2018
Last Updated
May 15, 2018
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03524703
Brief Title
Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion
Official Title
Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
dysphagia, anterior cervical fusion, chewing gum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chewing Gum Group
Arm Type
Experimental
Arm Description
Patients who receive anterior cervical fusion and have mild or moderate dysphagia postoperatively, will be randomized into two groups. Subjects assigned to the Chewing Gum Group are asked to chew gum four times a day for 5 days (15 minutes each time) after surgery in addition to standard cares. Standard cares include cleaning the wound every 2 days, wearing a collar, pain management, and education.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients who receive anterior cervical fusion and have mild or moderate dysphagia postoperatively, will be randomized into two groups. Subjects assigned to the Control Group receive standard cares and are asked not to chew gum within 5 days after surgery. Standard cares include cleaning the wound every 2 days, wearing a collar, pain management, and education.
Intervention Type
Other
Intervention Name(s)
chewing gum
Intervention Description
Chewing gum four times per day for 5 days, 15 minutes each time.
Primary Outcome Measure Information:
Title
Dysphagia Short Questionnaire (DSQ) score
Description
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.
Time Frame
Change from the 1st day after surgery to the 7th day after surgery.
Secondary Outcome Measure Information:
Title
Bazaz grading system
Description
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.
Time Frame
Change from the 1st day after surgery to the 7th day after surgery.
Title
Prevertebral soft tissue swelling
Description
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.
Time Frame
The 3rd days after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunbing Chang, M.D., Ph.D.
Phone
86-020-83827812
Ext
61011
Email
cspine@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunbing Chang, M.D., Ph.D.
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunbing Chang, M.D., Ph.D.
Phone
086-020-83827812
Ext
61011
Email
cspine@qq.com
First Name & Middle Initial & Last Name & Degree
Guoyan Liang, M.D., Ph.D.
Phone
086-020-83827812
Ext
61011
Email
410330757@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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