Clinical trial 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?
An investigational oral medication being studied for acute radicular low back pain.
Also referred to as Ibuprofen.
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 study is testing whether giving a steroid pill for two days improves pain and function compared to a pretend pill, while all get ibuprofen and a back‑pain lesson.
- Who it's for
- You may be able to join if you are an adult who went to the emergency department for sudden back pain that radiates into your leg.
- What's involved
- You will take a pill in the emergency department, either a real steroid or a pretend pill, and you will get a week’s supply of ibuprofen. You will also attend a short lesson about back pain. Afterward, you will answer phone questions at 2 and 7 days.
- Time commitment
- The study lasts one week, with a visit to the emergency department and two phone check‑ins at 2 and 7 days.
- 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.
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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at The Bronx, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.