Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion
NCT ID: NCT03524703
Last Updated: 2018-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2018-04-28
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chewing Gum Group
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.
chewing gum
Chewing gum four times per day for 5 days, 15 minutes each time.
Control Group
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.
No interventions assigned to this group
Interventions
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chewing gum
Chewing gum four times per day for 5 days, 15 minutes each time.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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YunBing Chang
Head of Spine Department
Principal Investigators
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Yunbing Chang, M.D., Ph.D.
Role: STUDY_CHAIR
Guangdong Provincial People's Hospital
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GDREC 2018151H
Identifier Type: -
Identifier Source: org_study_id
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