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New treatment option for Radiculopathy, Lumbosacral Region
Official title Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
ClinicalTrials.gov ID: NCT05721027
What this study is testing
What is Ibuprofen 400 mg?
Ibuprofen 400 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for radiculopathy, lumbosacral region.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the...
- Patient is to be discharged home.
- Age 18-70 Enrollment will be limited to adults \<70 years because of the increased risk of adverse medication effects in older adults.
- Pain duration \<2 week
- Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more...
You likely can't join if
- Not available for follow-up
- Pregnant
- Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
- Allergic to or intolerant of investigational medications
- Chronic steroid use
- Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe...
See the full eligibility criteria
- Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have...
- Patient is to be discharged home.
- Age 18-70 Enrollment will be limited to adults \<70 years because of the increased risk of adverse medication effects in older adults.
- Pain duration \<2 week
- Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain/sciatica are at increased risk of poor pain and...
- Non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month
- Functionally impairing radicular LBP: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire
- Not available for follow-up
- Pregnant
- Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
- Allergic to or intolerant of investigational medications
- Chronic steroid use
- Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR...
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
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, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. 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.