Recruiting

Duloxetine

Sponsor:

Montefiore Medical Center

Code:

NCT05851976

Conditions

Back Pain, Low

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Naproxen

Duloxetine

Study Details

Brief summary:

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

Back Pain, Low

Study ID

NCT05851976

Start date

Oct 4, 2023

Status verified date

Dec, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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:

1. history of hypersensitivity to NSAIDs or aspirin
2. active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed
3. Severe heart failure (NYHA 2 or worse)
4. uncontrolled blood pressure (>160/100)
5. Glomerular Filtration Rate (GFR) <60ml/min
6. Current use of anti-coagulants
7. cirrhosis or acute hepatitis
  • Contra-indication to duloxetine:

1. alcohol use disorder
2. chronic liver disease
3. chronic kidney disease
4. glaucoma
5. Active use of medication for depression
6. 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Naproxen + duloxetine

placebo comparator: Naproxen + placebo

Interventions

Naproxen

Naproxen 500mg twice daily for 16 days

Duloxetine

Duloxetine 60mg daily for 14 days

Primary outcome measure

  • Number of participants with moderate or severe Low Back Pain (LBP) [ Time Frame: 16 days, 42 days and 84 days after ED discharge ]

Central Contacts and Locations

Central contacts

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

More Information

Sponsor

Montefiore Medical Center

Last update posted

Dec 2, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-12-02.