Steroid Injections for Radiating Back Pain
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single interlaminar lumbar spine steroid injection containing either Triamcinolone or Dexamethasone at varying doses
Follow-up
Participants are monitored for pain intensity, physical function, and quality of life 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
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg.
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg.
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
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%).
4.
digitalcommons.pcom.edu
digitalcommons.pcom.edu/cgi/viewcontent.cgi?article=1196&context=pa_systematic_reviewsIs 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.
8.
journals.lww.com
journals.lww.com/clinicalpain/fulltext/2021/09000/safety_of_epidural_steroid_injections_for.9.aspxSafety of Epidural Steroid Injections for Lumbosacral...
Although effective in certain patient populations, ESIs have been associated with serious complications, including paralysis and death.
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