This prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative IV steroid versus saline on swallowing after anterior cervical spine surgery
This investigation is a prospective, randomized, double-blind, controlled trial testing a single dose of peri-operative steroid versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale, the EAT10 survey, and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
78
Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
West Virginia University Department of Orthopaedics
Morgantown, West Virginia, United States
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Day 1
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Day 2
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Week 1
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Week 2
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
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Time frame: Baseline to Month 3
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Month 12
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Month 1
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Month 6
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Day 1
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Day 2
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Week 1
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Week 2
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Month 1
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Month 3
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Month 6
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Month 12
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Day 1
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Day 2
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Week 1
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Week 2
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Month 1
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Month 3
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Month 6
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Month 12