Steroid Injections for Radiating Back Pain

Overseen By Nareka Trewick, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Oral pain meds

Disqualifiers: Pregnancy, Back surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to evaluate the efficacy of interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, to evaluate the efficacy of interlaminar steroid injections at improving quality of life and function in lumbar radiculopathy at varying doses, and to evaluate difference in efficacy between triamcinolone and dexamethasone interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, with the overarching hypotheses that there is no difference in reported pain reduction, quality of life, or function among patients receiving low, moderate, or high doses, and no difference in reported pain reduction between triamcinolone and dexamethasone.

Who Is on the Research Team?

Seyed A mostoufi, MD

Principal Investigator

Christine E. Lynn Rehabilitation Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am an adult and able to give my consent.

I have never had back surgery.

I have had lumbar spine injections using the interlaminar approach.

Exclusion Criteria

Pregnant women

I am an adult who cannot give consent for myself.

I have used oral pain medications other than Tylenol in the past 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single interlaminar lumbar spine steroid injection containing either Triamcinolone or Dexamethasone at varying doses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain intensity, physical function, and quality of life post-procedure

6 weeks

2 visits (in-person) at 2 weeks and 6 weeks post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Triamcinolone

How Is the Trial Designed?

Group I: Triamcinolone: 80 mg Group Experimental Treatment 1 Intervention

Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg

Group II: Triamcinolone: 40 mg Group Experimental Treatment 1 Intervention

Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg

Group III: Triamcinolone: 10 mg Group Experimental Treatment 1 Intervention

Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg

Group IV: Dexamethasone: 8 mg Group Experimental Treatment 1 Intervention

Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg.

Group V: Dexamethasone: 4 mg Group Experimental Treatment 1 Intervention

Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg.

Group VI: Dexamethasone: 2 mg Group Experimental Treatment 1 Intervention

Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+