Duloxetine for LBP

NCT05851976 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2023-14971
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with moderate or severe Low Back Pain (LBP)

  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.

  16 days, 42 days and 84 days after ED discharge

Secondary Outcomes (5)

• Number of Participants experiencing LBP based on the Roland Morris Disability Questionnaire (RMDQ)

  9 days, 16 days, 23 days, and 42 days after Emergency Department (ED) discharge

• Frequency of LBP

  9 days, 16 days, 23 days, and 42 days after ED discharge

• Number of visits to a healthcare provider

  9 days, 16 days, 23 days, and 42 days after ED discharge

• The number of patients experiencing Depressive Symptoms

  9 days, 16 days, 23 days, and 42 days after ED discharge

• The number of patients reporting Satisfaction with treatment

  9 days, 16 days, 23 days, and 42 days after ED discharge

Study Arms (2)

Naproxen + duloxetine

EXPERIMENTAL

Drug: Naproxen; Drug: Duloxetine

Naproxen + placebo

PLACEBO COMPARATOR

Drug: Naproxen

Interventions

Naproxen DRUG

Naproxen 500mg twice daily for 16 days

Naproxen + duloxetine; Naproxen + placebo

Duloxetine DRUG

Duloxetine 60mg daily for 14 days

Naproxen + duloxetine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Naproxen; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Benjamin Friedman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Friedman, MD

CONTACT

718-920-6626; befriedm@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: October 4, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)