This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.
This investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale 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
74
Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
West Virginia University
Morgantown, West Virginia, United States
Swallowing Difficulty
Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.
Time frame: 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months
Change in Quality of Life
Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability.
Time frame: Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.
Fusion Rate Steroid vs Placebo
Participants were considered fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.
Time frame: 1 year
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