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Serotonin-Norepinephrine Reuptake Inhibitor

Duloxetine for Lower Back Pain

Phase 4
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire
Pain duration <2 weeks (336 hours).
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will investigate if a drug can reduce chronic back pain. Patients with acute low back pain will be studied to see if duloxetine can help prevent it from lasting 3 months.

Who is the study for?
This trial is for adults aged 18-64 with recent non-radicular lower back pain that's bad enough to affect their daily life. They must not be pregnant, breastfeeding, or have allergies to the study medications. People with chronic liver or kidney disease, glaucoma, depression medication use, high suicide risk, chronic pain syndromes, severe heart failure or uncontrolled blood pressure are excluded.Check my eligibility
What is being tested?
The study is testing if duloxetine can prevent long-term low back pain in patients who come to the ER with acute symptoms. Participants will receive either naproxen (a common anti-inflammatory drug) or duloxetine (usually used for depression and nerve pain) to see which one helps more.See study design
What are the potential side effects?
Duloxetine may cause nausea, dry mouth, sleepiness, constipation and increased sweating. Naproxen might lead to stomach upset/pain, heartburn, headache and dizziness. Serious side effects could include liver damage from duloxetine and heart attack/stroke risks from naproxen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My back pain significantly affects my daily activities.
My pain has lasted less than 2 weeks.
My pain is not due to nerve damage.
My lower back pain is due to muscle or bone issues, not injury or nerve problems.
I went to the ER mainly for lower back pain, not including pain on the sides of my body.
I am between 18 and 64 years old.
I experienced back pain less than once a week before my recent severe episode.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Moderate or severe pain
Secondary outcome measures
Number of Participants demonstrating improvement based on Roland Morris Disability Questionnaire results

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Naproxen + duloxetineExperimental Treatment2 Interventions
Group II: Naproxen + placeboPlacebo Group1 Intervention
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Completed Phase 4

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,076 Total Patients Enrolled

Media Library

Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05851976 — Phase 4
Lower Back Pain Research Study Groups: Naproxen + duloxetine, Naproxen + placebo
Lower Back Pain Clinical Trial 2023: Duloxetine Highlights & Side Effects. Trial Name: NCT05851976 — Phase 4
Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05851976 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to be a participant in this clinical trial?

"The eligibility criteria for this clinical trial necessitate that participants are aged between 18 and 64, as well as suffering from lower back pain. A total of 100 individuals can be enrolled in the study."

Answered by AI

What potential hazards may accompany the use of Naproxen and duloxetine in combination?

"Naproxen + duloxetine has been granted approval and is thus evaluated as a 3 on our team's safety scale."

Answered by AI

Does the research permit individuals aged 25 and above to participate?

"Based on the trial's requirements, eligible patients must be between 18 and 64 years old."

Answered by AI

Is enrollment still accessible to participants in this trial?

"This clinical trial, which was initially posted on June 1st 2023 and last updated May 1st 2023 according to the information presented on clinicaltrials.gov, is not currently seeking participants. Despite this, 346 other medical studies are actively recruiting volunteers at present."

Answered by AI

Who else is applying?

What site did they apply to?
Montefiore Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~80 spots leftby Sep 2026