Effectiveness of Cervical Transforaminal Epidural Steroid Injection

• Status: Recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Adult patients aged 18-80 capable of understanding and providing consent in English and capable of complying with the outcome instruments used.

• Arm pain or shoulder girdle pain/periscapular pain with or without neck pain with duration less than or equal to 6 months.

• 3-day average numeric pain rating score (NRS) for arm pain or shoulder girdle/periscapular pain of at least 4/10 at baseline evaluation, with neck pain score not exceeding arm and/or shoulder girdle/periscapular pain score.

• MRI (or CT if MRI not available) shows either a one level cervical disc herniation, disc osteophyte complex or degenerative foraminal stenosis, corresponding in side and location with predominately unilateral radicular pain, with or without neurological deficits. MRI may show degenerative changes at other levels.

• Patient consents to treatment with epidural injection in a shared decision-making process with the treating physician.

• Pain duration of at least 6 weeks or more.

Exclusion Criteria:

• Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).

• Those involved in active litigation relevant to their pain.

• The patient is incarcerated.

• Neck pain is greater than arm pain or shoulder girdle/periscapular pain.

• Bilateral radicular signs/symptoms (< 90% laterality of pain intensity, or bilateral neurological signs).

• BMI>35.

• Prior epidural steroid injections for treatment of current episode.

• Those unable to read English and complete the assessment instruments.

• Spondylolisthesis at the involved or adjacent segments.

• Systemic inflammatory arthritis (e.g., rheumatoid, lupus).

• Addictive behavior, severe clinical depression, or psychotic features.

• Possible pregnancy or other reason that precludes the use of fluoroscopy.

• Treatment of infection with antibiotics within the past 7 days.

• Progressive motor deficit and/or clinical signs of myelopathy.

• History of prior cervical spine surgery.

• Medical conditions causing significant functional disability (e.g., stroke, COPD)