NCT05851976 · Montefiore Medical Center
Duloxetine for LBP
What this study 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.
View original scientific description
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.
Interventions
DRUG
Naproxen
Naproxen 500mg twice daily for 16 days
DRUG
Duloxetine
Duloxetine 60mg daily for 14 days
Primary outcome measures
Number of participants with moderate or severe Low Back Pain (LBP)
Time frame: 16 days, 42 days and 84 days after ED discharge
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used to assess LBP. Study participants will be asked to describe their worst back pain over the previous 24 hours. The number of patients reporting with "Moderate" or "Severe" pain will be summarized by study arm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
- Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
- 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
Exclusion criteria
- 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
- Contra-indications to non-steroidal anti-inflammatory drugs:
- 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
- Contra-indication to duloxetine:
- alcohol use disorder
- chronic liver disease
- chronic kidney disease
- 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. Now we would like to exclude patients with a PHQ9 score \>10 or symptoms of feeling down, depressed, or hopeless
Where
- The Bronx, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 2, 2025 · Source of record for eligibility and locations