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NCT04544683 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Cervical Transforaminal Epidural Steroid Injection
A Phase 4 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT04544683 is a Phase 4 study that has completed, run by University of Utah. The registered enrollment target is 33 participants.
The verdict
NCT04544683, a Phase 4 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
Study Purpose: This study is intended to monitor outcomes for 1 year following cervical TFESI. Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion, we conservatively estimate a study enrollment period of 18 months and a total period of 2.5 years from enrollment to final follow-up data collection. If the study were to theoretically start enrolling in July 2019, we would anticipate completion by February 2022. Objectives: 1. Determine the proportion of patients with an 80% or greater improvement in arm and neck numerical rating scale pain (NRS) score following an initial cervical transforaminal steroid injection (TFESI) at 4 weeks post-injection and the duration of response up to 12 months. 2. Determine the proportion of patients with a 50%-79% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 3. Determine the proportion of patients with less than 50% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 4. Determine the proportion of patients with an initial injection plus up to 3 additional injections that maintain 80% or greater, as well as 50-79%, improvement in arm and neck NRS score for up to 12 months. 5. Determine the proportion of patients with a clinically significant change in function defined by a minimally clinically significant change (MCIC) (≥10 point improvement ) or 30% improvement in Neck Disability Index (NDI) score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 6. Determine the proportion of patients with clinically significant improvement in the Medication Quantification Scale (MQS III) score (≥6.8 point change , equivalent to 10 oral morphine equivalents ) following an initial cervical TFESI at 4 weeks post-injection and
Interventions
- DRUG Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-10-23 |
| Est. Completion | 2023-12-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04544683
The ClinicalTrials.gov registry entry for NCT04544683 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate is the first listed.
NCT04544683 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04544683 about?
NCT04544683 is a clinical study titled "Effectiveness of Cervical Transforaminal Epidural Steroid Injection". Study Purpose: This study is intended to monitor outcomes for 1 year following cervical TFESI. Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion, we conservatively estimate a study enrollment period of 18 months and a...
What is the current status of trial NCT04544683?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2018-10-23. Estimated completion is 2023-12-07.
What interventions are being tested in trial NCT04544683?
The interventions under investigation include: Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate (DRUG).
Who is sponsoring clinical trial NCT04544683?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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