What is the mechanism of action of this treatment?

Cervical transforaminal epidural steroid injections deliver corticosteroids directly to the epidural space, reducing inflammation and alleviating pain by decreasing the activity of inflammatory mediators. This is particularly important for patients with radiating pain, as inflammation around nerve roots can cause significant discomfort and functional impairment. By targeting the source of inflammation, these injections can provide both short-term and long-term pain relief, potentially reducing the need for surgical intervention. Other treatments, such as physical therapy and anti-inflammatory medications, work by improving mobility and reducing overall inflammation, respectively, but may not offer the targeted relief that epidural steroid injections provide.

What side effects are associated with this type of intervention?

Cervical transforaminal epidural steroid injections, used to treat radiating pain, can have several side effects. Commonly reported adverse effects include localized pain at the injection site, headaches, dizziness, and transient nerve irritation. More serious but rare complications can include infection, bleeding, and nerve damage. There is also a risk of serious neurologic events, as noted by the FDA, which can include stroke or paralysis. Patients should discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Epidural steroid injections (ESIs) have been widely used and are FDA-approved for the treatment of radiating pain, such as that caused by herniated discs, spinal stenosis, and other spinal conditions. These injections deliver corticosteroids directly into the epidural space to reduce inflammation and alleviate pain. Commonly used corticosteroids include triamcinolone, methylprednisolone, and dexamethasone. While specific FDA approvals for cervical transforaminal epidural steroid injections are not detailed, the general use of ESIs for managing radiating pain is well-established and supported by clinical guidelines and expert opinion.

What other types of research exist?

Promising novel alternatives to cervical transforaminal epidural steroid injections for radiating pain include: 1) Platelet-Rich Plasma (PRP) injections, which utilize the patient's own blood components to promote healing and reduce inflammation. 2) Autologous blood injections, which have shown efficacy in treating tendinopathies and may offer benefits for radiating pain. 3) Topical nitric oxide application, which has been effective in treating chronic tendinosis and may provide pain relief. 4) Percutaneous needle tenotomy, a minimally invasive procedure that promotes healing through targeted tendon punctures. These alternatives offer potential benefits and should be discussed with a healthcare provider to determine the best course of action.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after the first injection

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether injecting steroids near the spinal nerves in the neck can help patients with severe neck and arm pain avoid surgery. The treatment aims to reduce inflammation and pain by delivering medication directly to the affected area. The study focuses on patients who have not improved with other treatments and are considering 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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after the first injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months after the first injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after the first injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Avoidance of Neck Surgery

Secondary study objectives

Disability

Numeric Pain Score

Numeric Pain Scre

+1 more

Awards & Highlights

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.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cervical transforaminal epidural steroid injections deliver corticosteroids directly to the epidural space, reducing inflammation and alleviating pain by decreasing the activity of inflammatory mediators. This is particularly important for patients with radiating pain, as inflammation around nerve roots can cause significant discomfort and functional impairment. By targeting the source of inflammation, these injections can provide both short-term and long-term pain relief, potentially reducing the need for surgical intervention. Other treatments, such as physical therapy and anti-inflammatory medications, work by improving mobility and reducing overall inflammation, respectively, but may not offer the targeted relief that epidural steroid injections provide.