Effectiveness of Cervical Transforaminal Epidural Steroid Injection
Status:
Recruiting
Trial end date:
2023-07-30
Target enrollment:
Participant gender:
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 the duration of response up to 12 months.
6. Determine the proportion of patients with clinically significant improvement in the
categorical EuroQol 5 Dimensions tool (EQ-5D) defined by ≥0.03 following an initial cervical
TFESI at 4 weeks post-injection and the duration of response up to 12 months.
7. Compare patient demographic, clinical, and imaging characteristics between response groups
and perform predictive modeling to better understand variables that increase the likelihood
of a successful clinical outcome.
8. Report adverse effects.