Trial · NCT02416934
Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline
NCT02416934, Not applicable, Completed, West Virginia University; results first posted 2018-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline. Trials, record NCT02416934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02416934
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline
- NCT number
- NCT02416934
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 74 participants, actual
- Lead sponsor
- West Virginia University
- Conditions
- Dysphagia
- Interventions
- Treatment 1; Dexamethasone, Treatment 0; Saline placebo
- First posted
- 2015-04-15
- Last updated
- 2019-02-05
- Results first posted
- 2018-03-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Swallowing Difficulty | 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months | 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. |
| Secondary | Change in Quality of Life | Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year. | 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. |
| Secondary | Fusion Rate Steroid vs Placebo | 1 year | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Swallowing Difficulty | 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months | Treatment 1; Dexamethasone or Treatment 0; Saline placebo. Treatment 1 received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. Dosage was approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 0 received similar volume of saline on same schedule for three doses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Quality of Life | Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year. | Neck Disability Index change from baseline to 1 year or last visit as appropriate. Not all subjects followed up at 1 year. | units on a scale | MEAN |
| SECONDARY | Fusion Rate Steroid vs Placebo | 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Swallowing Difficulty | Dexamethasone DSQ | Difficulty swallowing Baseline | 16 | Participants | |
| Swallowing Difficulty | Saline Placebo DSQ | Difficulty swallowing Baseline | 14 | Participants | |
| Swallowing Difficulty | Dexamethasone Bazaz | Difficulty swallowing Baseline | 5 | Participants | |
| Swallowing Difficulty | Saline Placebo Bazaz | Difficulty swallowing Baseline | 7 | Participants | |
| Swallowing Difficulty | Dexamethasone DSQ | Difficulty swallowing day 1 | 24 | Participants | |
| Swallowing Difficulty | Saline Placebo DSQ | Difficulty swallowing day 1 | 28 | Participants | |
| Swallowing Difficulty | Dexamethasone Bazaz | Difficulty swallowing day 1 | 19 | Participants | |
| Swallowing Difficulty | Saline Placebo Bazaz | Difficulty swallowing day 1 | 21 | Participants | |
| Swallowing Difficulty | Dexamethasone DSQ | Difficulty swallowing day 2 | 22 | Participants | |
| Swallowing Difficulty | Saline Placebo DSQ | Difficulty swallowing day 2 | 28 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment 1; Dexamethasone | 36 | |
| Overall Study | STARTED | Treatment 0; Saline Placebo | 38 | |
| Overall Study | Double Blind (0-52 Weeks) | Treatment 1; Dexamethasone | 36 | |
| Overall Study | Double Blind (0-52 Weeks) | Treatment 0; Saline Placebo | 38 | |
| Overall Study | Last Participant Completed 1 yr | Treatment 1; Dexamethasone | 33 | |
| Overall Study | Last Participant Completed 1 yr | Treatment 0; Saline Placebo | 31 | |
| Overall Study | COMPLETED | Treatment 1; Dexamethasone | 33 | |
| Overall Study | COMPLETED | Treatment 0; Saline Placebo | 31 | |
| Overall Study | NOT COMPLETED | Treatment 1; Dexamethasone | 3 | |
| Overall Study | NOT COMPLETED | Treatment 0; Saline Placebo | 7 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | intraoperative musculoskeletal injury | Surgical and medical procedures | Treatment 1; Dexamethasone | 0 | 33 | 0 |
| serious | intraoperative musculoskeletal injury | Surgical and medical procedures | Treatment 0; Saline Placebo | 0 | 31 | 0 |
| serious | intraoperative neurological injury | Surgical and medical procedures | Treatment 1; Dexamethasone | 0 | 33 | 0 |
| serious | intraoperative neurological injury | Surgical and medical procedures | Treatment 0; Saline Placebo | 0 | 31 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment 1; Dexamethasone | 0 | 33 |
| Total, all-cause mortality | Treatment 0; Saline Placebo | 0 | 31 |
| Total, other adverse events | Treatment 1; Dexamethasone | 0 | 33 |
| Total, other adverse events | Treatment 0; Saline Placebo | 0 | 31 |
| Total, serious adverse events | Treatment 1; Dexamethasone | 0 | 33 |
| Total, serious adverse events | Treatment 0; Saline Placebo | 0 | 31 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment 1; Dexamethasone vs Treatment 0; Saline Placebo: deaths from any cause | Trial comparisons |
| Treatment 1; Dexamethasone vs Treatment 0; Saline Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02416934
GET https://conductscience.org/api/trials/v1/NCT02416934/results?page=2