Phase 4
Completed N=120
Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach
Cervical Radiculopathy
Source: ClinicalTrials.gov NCT03382821 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score — 49.1; 68.5 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score |
49.1; 68.5 | — |
| SECONDARY Neck Disability Index-5 |
48; 62; 56; 58; 55; 56 | — |
| SECONDARY Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III |
16; 19; 20; 17; 15; 19 | — |
| SECONDARY The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved") |
41; 59; 42; 57; 55; 53 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-80.
- Clinical diagnosis of unilateral C4-C8 radicular pain.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
- Numerical Rating Scale (NRS) pain score of 4 or higher.
- Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
Exclusion Criteria
- Refusal to participate, provide consent, or provide follow-up information for the 6-month duration of the study.
- Contraindications to Cervical Epidural Steroid Iinjection (CESI) (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for Cervical epidural steroid injection (CESI), and pregnancy).
- Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
- Current glucocorticoid use or Epidural Steroid Injection (ESI) within past 6 months.
- Prior cervical spine surgery.
- Patient request for or requirement of conscious sedation for the injection procedure.
Data sourced from ClinicalTrials.gov (NCT03382821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.