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New treatment option for Lumbosacral Radiculopathy
Official title Procedural Framing and Epidural Steroid Injection Outcomes
ClinicalTrials.gov ID: NCT07498140
What this study is testing
- What it's testing
- Back pain is the leading cause of disability and military medical boards across the globe. Epidural steroid injections (ESI) are the most commonly performed pain procedure in the world.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Age \> 18
- Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness...
- Duration of pain \>6 weeks
- NRS leg pain score \> 4 (or if 3/10, greater or equal to back pain)
- MRI evidence of spinal pathology consistent with symptoms
You likely can't join if
- Untreated coagulopathy
- Previous spine surgery
- No MRI or non-concordant MRI study
- Leg pain \> 15 years duration
- Epidural steroid injection within past 2 years
- Signs or symptoms of cauda equina syndrome
See the full eligibility criteria
- Age \> 18
- Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
- Duration of pain \>6 weeks
- NRS leg pain score \> 4 (or if 3/10, greater or equal to back pain)
- MRI evidence of spinal pathology consistent with symptoms
- Candidates for ESI and pharmacotherapy
- Untreated coagulopathy
- Previous spine surgery
- No MRI or non-concordant MRI study
- Leg pain \> 15 years duration
- Epidural steroid injection within past 2 years
- Signs or symptoms of cauda equina syndrome
- Previous failed trials with gabapentin and pregabalin and tricyclic antidepressants and duloxetine
- Allergic reactions to contrast dye prohibiting injection (e.g., tranforaminal ESI), gabapentinoids, tricyclic antidepressants or duloxetine, and contraindications to all of the above medications
- Referrals from surgery for diagnostic injections for surgical evaluation
- Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
- Pregnancy
- Inability to understand basic English
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Bangkok, Thailand
- Lviv, Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Bethesda, Maryland, United States; Bangkok, Thailand; Lviv, Ukraine. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.