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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreSPIES 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need injections in more than one part of your neck.You currently have an infection.You have diabetes, whether it's type 1 or type 2.You have had a recent serious injury.You have a neurological problem that is getting worse and causing muscle weakness.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.You have a medical condition that may affect the examination of your neck nerves or cause pain (such as peripheral neuropathy).You have the disease in both sides of your body.You have a condition that makes it risky for you to receive injections.You do not have significant arm pain that is worse than your neck pain.You have neck pain without major nerve problems or certain findings on a special imaging test.
Research Study Groups:
This trial has the following groups:- Group 1: Lidocaine
- Group 2: Lidocaine with Dexamethasone
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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