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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: Completed Phase 4 study, sponsored by University of Utah.
NCT04544683 is a Phase 4 study that has completed, run by University of Utah. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Percentage of participants reporting 50% or greater improvement in index arm pain following an initial cervical transforaminal injection of steroid (CTFESI) at 1, 3, 6, and 12 months post-injection. Patient-reported arm pain intensity scores were captured at baseline and the designated follow-up time points using an 11-point Numeric Rating Scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable".
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 |
What the finished NCT04544683 record still lists
NCT04544683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04544683's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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