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Epidural Steroid Injections for Neck Pain (SPIES Trial)

Phase 4
Waitlist Available
Led By Sam Bhagia, MD
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed 6 weeks of conservative treatment (conservative treatment is defined as relative rest, home exercise, physical therapy, and use of anti-inflammatory and/or analgesic medications),
Subjects who have cervical radicular pain without significant neurologic deficit (neurologic deficit is defined as manual muscle testing less than 3/5), MRI/CT findings of neural compression (neural compression is defined as disc herniation or central or foraminal spinal stenosis),
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

SPIES Trial Summary

This trial is looking at whether a common pain relief injection for people with neck pain can help avoid the need for surgery.

Who is the study for?
This trial is for individuals who have persistent neck and arm pain due to nerve compression, confirmed by MRI/CT scans, and haven't improved after 6 weeks of non-surgical treatments. They should be considered good candidates for surgery but are looking into non-surgical options. People with diabetes, recent trauma, active infections or neurological deficits, pregnancy or litigation related to neck injury cannot participate.Check my eligibility
What is being tested?
The study tests if injecting steroids directly near the nerves in the neck (cervical transforaminal epidural steroid injections) can reduce pain enough to avoid surgery. Participants will receive either Lidocaine alone or Lidocaine with Dexamethasone through these targeted injections.See study design
What are the potential side effects?
Possible side effects from the injections may include temporary increases in pain, headaches, dizziness, bleeding at the injection site, infection risk increase and rare cases of nerve damage. Side effects specific to steroids like Dexamethasone could also involve mood swings or elevated blood sugar levels.

SPIES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have tried resting, doing specific exercises at home, seeing a physical therapist, and taking anti-inflammatory or pain-relief medications for 6 weeks, but your condition did not improve.
Select...
You have neck pain without major nerve problems or certain findings on a special imaging test.

SPIES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Avoidance of Neck Surgery
Secondary outcome measures
Disability
Numeric Pain Score
Numeric Pain Scre
+1 more

SPIES Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lidocaine with DexamethasoneExperimental Treatment1 Intervention
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Group II: LidocaineActive Control1 Intervention
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Find a Location

Who is running the clinical trial?

OrthoCarolina Research Institute, Inc.Lead Sponsor
34 Previous Clinical Trials
5,866 Total Patients Enrolled
Charlotte Surgery Center an affiate of SCAUNKNOWN
Sam Bhagia, MDPrincipal InvestigatorOrthoCarolina Research Institute, Inc.

Media Library

Cervical Transforaminal Epidural Steroid Injections Clinical Trial Eligibility Overview. Trial Name: NCT02226159 — Phase 4
Radiating Pain Research Study Groups: Lidocaine, Lidocaine with Dexamethasone
Radiating Pain Clinical Trial 2023: Cervical Transforaminal Epidural Steroid Injections Highlights & Side Effects. Trial Name: NCT02226159 — Phase 4
Cervical Transforaminal Epidural Steroid Injections 2023 Treatment Timeline for Medical Study. Trial Name: NCT02226159 — Phase 4

Frequently Asked Questions

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