Actively Recruiting
Duloxetine for LBP
Led by Montefiore Medical Center · Updated on 2025-12-02
120
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.
CONDITIONS
Official Title
Duloxetine for LBP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Present to Emergency Department (ED) primarily for management of low back pain between the lower border of the scapulae and upper gluteal folds
- Musculoskeletal cause of low back pain, excluding non-musculoskeletal causes like urinary tract infection or ovarian cysts
- Discharged home from the ED (not admitted to hospital)
- Age between 18 and 64 years
- Non-radicular pain not radiating below the gluteal folds
- Pain duration less than 2 weeks (336 hours)
- Back pain occurring less than once per week before the current episode
- Baseline Roland-Morris Disability Questionnaire score greater than 5 indicating functionally impairing back pain
You will not qualify if you...
- Not available for follow-up
- Pregnant or breastfeeding
- Chronic pain syndrome with moderate or severe pain on 50% or more days for at least 3 months
- Allergy or intolerance to study medications
- Contraindications to NSAIDs including hypersensitivity, peptic ulcer, gastrointestinal bleeding, severe heart failure (NYHA 2 or worse), uncontrolled blood pressure (>160/100), low kidney function (GFR <60 ml/min), current use of anticoagulants, cirrhosis or acute hepatitis
- Contraindications to duloxetine including alcohol use disorder, chronic liver disease, chronic kidney disease, glaucoma, active use of medication for depression, PHQ-9 score greater than 10 or symptoms of depression or suicidal thoughts
- PHQ-9 score greater than 4 with symptoms of feeling down, depressed, or hopeless
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
B
Benjamin Friedman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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