Clinical trial NCT03711474: Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)
Official title: Impact of Single Dose Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysphagia
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized; double blinded (participant and investigator)
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Elective anterior approach to subaxial cervical spine (C3 - T1);
* ages 18-80

Exclusion Criteria:

* Traumatic or tumor etiologies
* undergoing anterior-posterior operations
* neoplastic, or infectious conditions requiring surgery
* a history of previous anterior cervical spine surgery
* any patient requiring a halo vest
* patients on chronic steroids
* patients remaining intubated post-operatively (please see more under risks below)
* less than 18 years of age
* pregnant women
* no phone

Primary outcomes:
measure: Change in the Occurrence of Dysphagia -Bazaz Scale
timeFrame: Baseline to Day 1
measure: Change in the Occurrence of Dysphagia -Bazaz Scale
timeFrame: Baseline to Day 2
measure: Change in the Occurrence of Dysphagia -Bazaz Scale
timeFrame: Baseline to Week 1
measure: Change in the Occurrence of Dysphagia -Bazaz Scale
timeFrame: Baseline to Week 2
measure: Change in the Occurrence of Dysphagia -Bazaz Scale
timeFrame: Baseline to Month 3
measure: Change in the Occurrence of Dysphagia -Bazaz Scale
timeFrame: Baseline to Month 12
measure: Change in the Occurrence of Dysphagia -Bazaz Scale
timeFrame: Baseline to Month 1
measure: Change in the Occurrence of Dysphagia -Bazaz Scale
timeFrame: Baseline to Month 6
measure: Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
timeFrame: Baseline to Day 1
measure: Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
timeFrame: Baseline to Day 2
measure: Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
timeFrame: Baseline to Week 1
measure: Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
timeFrame: Baseline to Week 2
measure: Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
timeFrame: Baseline to Month 1
measure: Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
timeFrame: Baseline to Month 3
measure: Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
timeFrame: Baseline to Month 6
measure: Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
timeFrame: Baseline to Month 12
measure: Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
timeFrame: Baseline to Day 1
measure: Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
timeFrame: Baseline to Day 2
measure: Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
timeFrame: Baseline to Week 1
measure: Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
timeFrame: Baseline to Week 2
measure: Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
timeFrame: Baseline to Month 1
measure: Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
timeFrame: Baseline to Month 3
measure: Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
timeFrame: Baseline to Month 6
measure: Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
timeFrame: Baseline to Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Department of Orthopaedics
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Scott Daffner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song KJ, Lee SK, Ko JH, Yoo MJ, Kim DY, Lee KB. The clinical efficacy of short-term steroid treatment in multilevel anterior cervical arthrodesis. Spine J. 2014 Dec 1;14(12):2954-8. doi: 10.1016/j.spinee.2014.06.005. Epub 2014 Jun 12.
citation: Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1.
citation: Leonard R, Belafsky P. Dysphagia following cervical spine surgery with anterior instrumentation: evidence from fluoroscopic swallow studies. Spine (Phila Pa 1976). 2011 Dec 1;36(25):2217-23. doi: 10.1097/BRS.0b013e318205a1a7.
citation: Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
citation: Skeppholm M, Ingebro C, Engstrom T, Olerud C. The Dysphagia Short Questionnaire: an instrument for evaluation of dysphagia: a validation study with 12 months' follow-up after anterior cervical spine surgery. Spine (Phila Pa 1976). 2012 May 15;37(11):996-1002. doi: 10.1097/BRS.0b013e31823a7a5b.
citation: Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.