Dysphagia After Anterior Cervical Decompression and Fusion of the Spine Clinical Trial
Official title:
Effect of Intravenous Corticosteroid Injections on Dysphagia After Anterior Cervical Spine Surgery: a Randomized, Double-blind, Placebo-controlled Study
| Verified date | September 2018 |
| Source | New York University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.
| Status | Terminated |
| Enrollment | 4 |
| Est. completion date | September 1, 2015 |
| Est. primary completion date | September 1, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - The subjects included in the study are patients undergoing an anterior cervical spine procedure. Exclusion Criteria: - Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Center for Musculoskeletal Care (CMC) | New York | New York |
| United States | NYU Langone Medical Center | New York | New York |
| United States | NY Spine Institute | Westbury | New York |
| Lead Sponsor | Collaborator |
|---|---|
| New York University School of Medicine |
United States,
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. — View 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. — View Citation
Martin RE, Neary MA, Diamant NE. Dysphagia following anterior cervical spine surgery. Dysphagia. 1997 Winter;12(1):2-8; discussion 9-10. — View Citation
Stewart M, Johnston RA, Stewart I, Wilson JA. Swallowing performance following anterior cervical spine surgery. Br J Neurosurg. 1995;9(5):605-9. — View Citation
Winslow CP, Winslow TJ, Wax MK. Dysphonia and dysphagia following the anterior approach to the cervical spine. Arch Otolaryngol Head Neck Surg. 2001 Jan;127(1):51-5. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intravenous Corticosteroids Effect on Post-operative Dysphagia | The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia. | 12 months | |
| Primary | The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients. | Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary. | 12 months | |
| Secondary | The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery. | Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration. | 12 months | |
| Secondary | Examine the Impact of Dexamethasone on the Development of Postoperative Nausea. | This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery. | Immediate post-operatively | |
| Secondary | Examine the Impact of Dexamethasone on Radicular Pain. | This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain. | 12 months | |
| Secondary | Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates. | The outcomes of surgery will be examined through the 1 year post-operative appointment. | 12 months |