Back Pain, Low study: Naproxen vs Duloxetine
Official title Duloxetine for LBP
ClinicalTrials.gov ID: NCT05851976
What this study is testing
What is Naproxen?
This is an investigational medication being studied to see if it helps with low back pain. It is designed to reduce inflammation and pain in the body.
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
- The study wants to see if duloxetine can help prevent back pain from lasting three months after an emergency visit.
- Who it's for
- Adults who have had acute low back pain and went to the emergency department.
- What's involved
- Participants will take duloxetine and may have follow‑up visits and pain assessments.
- Time commitment
- The study lasts about three months with several scheduled visits to track pain and medication use.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 64
You may be able to join if
- Present to Emergency Department (ED) primary for management of LBP, defined as pain originating between the lower border of the scapulae and the...
- Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like...
- Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not...
- Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in older patients.
- Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
You likely can't join if
- Not available for follow-up
- Pregnant or breast-feeding
- Chronic pain syndrome defined as moderate or severe pain anywhere in their body on \>= 50% of days for at least three months
- Allergic to or intolerant of investigational medications
- history of hypersensitivity to NSAIDs or aspirin
- active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed
See the full eligibility criteria
- Present to Emergency Department (ED) primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds.
- Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded.
- Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
- Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in older patients.
- Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
- Pain duration \<2 weeks (336 hours).
- Prior to the acute attack of LBP, back pain cannot occur more frequently than once per week.
- Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire
- Not available for follow-up
- Pregnant or breast-feeding
- Chronic pain syndrome defined as moderate or severe pain anywhere in their body on \>= 50% of days for at least three months
- Allergic to or intolerant of investigational medications
- history of hypersensitivity to NSAIDs or aspirin
- active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed
- Severe heart failure (NYHA 2 or worse)
- uncontrolled blood pressure (\>160/100)
- Glomerular Filtration Rate (GFR) \<60ml/min
- Current use of anti-coagulants
- cirrhosis or acute hepatitis
- alcohol use disorder
- chronic liver disease
- chronic kidney disease
- glaucoma
- Active use of medication for depression
- Score \> 10 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide, symptoms of feeling down, depressed, or hopeless PHQ9 score \>4.
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 64 years. 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.