Steroid Injections for Radiating Back Pain

NT
Overseen ByNareka Trewick, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of steroid injections in easing pain from lumbar radiculopathy, which is nerve pain radiating from the lower back. It compares different doses of two steroids, triamcinolone and dexamethasone, to determine their impact on pain relief, quality of life, and function. The researchers aim to discover any differences in outcomes between the doses or types of steroids used. This trial may suit individuals with MRI-confirmed lumbar radiculopathy, no prior back surgery, and who only use Tylenol or Acetaminophen for pain relief. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research helps understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

You can continue taking Tylenol or Acetaminophen, but you must stop using other oral pain medications during the 6 weeks after the injection.

What is the safety track record for these treatments?

Research has shown that both triamcinolone and dexamethasone are generally safe for relieving back pain. In previous studies, triamcinolone injections had a low complication rate of 0.6%, with any issues easily managed. However, higher doses of triamcinolone can raise blood sugar levels.

Dexamethasone is also considered safe. Studies suggest it provides significant pain relief without major side effects. However, like other steroid injections into the spine, it can rarely cause serious problems, such as paralysis. Overall, both treatments have a good safety record, but healthcare providers must monitor patients closely.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of Dexamethasone and Triamcinolone for radiating back pain because these steroid injections directly target inflammation at the source in the spine. Unlike many standard treatments, which may involve oral medications that affect the whole body, these injections deliver the steroid precisely where it's needed, potentially offering faster and more effective relief. Additionally, the trial explores varying dosages, which might help fine-tune the balance between effectiveness and side effects, offering a personalized approach to pain management.

What evidence suggests that this trial's treatments could be effective for lumbar radiculopathy?

This trial will compare the effectiveness of triamcinolone and dexamethasone for treating lumbar radiculopathy, which is nerve pain in the lower back. Research has shown that both triamcinolone and dexamethasone effectively treat this condition. Triamcinolone significantly relieves pain, especially in individuals with severe symptoms, and often outperforms other treatments for lower back pain. Studies have shown that patients receiving triamcinolone report more frequent and greater pain relief. Dexamethasone also eases this type of pain, with many patients experiencing significant improvements in both pain and movement. Some research suggests that dexamethasone may offer better pain relief and improved function two months after injection compared to other options. Both treatments have a strong record of reducing pain and enhancing quality of life for those with back pain.15678

Who Is on the Research Team?

SA

Seyed A mostoufi, MD

Principal Investigator

Christine E. Lynn Rehabilitation Center

Are You a Good Fit for This Trial?

This trial is for adults with MRI-confirmed lumbar radiculopathy (a type of back pain that radiates down the leg) who have not had back surgery and can give consent. Participants cannot be pregnant or use oral pain meds other than Tylenol/acetaminophen during the 6 weeks after injection.

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.
See 2 more

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.
See 2 more

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

Trial Overview

The study compares different doses of two steroid injections, dexamethasone and triamcinolone, given into the lower spine to see which works best for reducing pain and improving quality of life in people with lumbar radiculopathy.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Triamcinolone: 80 mg GroupExperimental Treatment1 Intervention
Group II: Triamcinolone: 40 mg GroupExperimental Treatment1 Intervention
Group III: Triamcinolone: 10 mg GroupExperimental Treatment1 Intervention
Group IV: Dexamethasone: 8 mg GroupExperimental Treatment1 Intervention
Group V: Dexamethasone: 4 mg GroupExperimental Treatment1 Intervention
Group VI: Dexamethasone: 2 mg GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

The Effectiveness of Oral Corticosteroids for Management ...

The recovery rate is approximately 80% within 8 weeks and 95% within 1 year.1) Cohen et al.2) reported that lumbar radiating pain could cause ...

Comparing pain relief and functional improvement between ...

However, the continuous outcomes did reveal the superiority of dexamethasone at 2 months post-injection in both pain relief and functional improvement (–0.57 [ ...

Intravenous Corticosteroid Therapy for Acute Lumbar ... - PMC

Results: The average IV steroid treatment was 3.9 (±2.8) days, with most patients showing significant pain relief allowing discharge (69.7%).

Is Dexamethasone Epidural Injection Effective in Relieving ...

Results: All three randomized controlled trials did display significant radicular pain relief with the use of an epidural steroid injection as ...

Efficacy of intramuscular glucocorticoid injection in patients ...

In this study, IV adrenocorticotrophic hormone infusion was found to partially or completely improve pain in 24 of 38 patients [26]. In 1975, ...

Systemic effects of fluoroscopically guided epidural steroid ...

Although ESIs are increasingly used as an effective treatment for spinal pain, there continues to be debate regarding their safety and efficacy [5,6]. For ...

Comparing the Effectiveness and Safety of ...

ylprednisolone, dexamethasone, or betamethasone will produce superior clinical outcomes in patients with radicular lumbar back pain when utilized in TFESIs.

Safety of Epidural Steroid Injections for Lumbosacral...

Although effective in certain patient populations, ESIs have been associated with serious complications, including paralysis and death.