Duloxetine for LBP

NCT ID: NCT05851976

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2027-05-31

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.

Detailed Description

Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.

Conditions

Back Pain, Low

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naproxen + duloxetine

Group Type: EXPERIMENTAL

Naproxen

Intervention Type: DRUG

Naproxen 500mg twice daily for 16 days

Duloxetine

Intervention Type: DRUG

Duloxetine 60mg daily for 14 days

Naproxen + placebo

Group Type: PLACEBO_COMPARATOR

Naproxen

Intervention Type: DRUG

Naproxen 500mg twice daily for 16 days

Interventions

Naproxen

Naproxen 500mg twice daily for 16 days

Intervention Type: DRUG

Duloxetine

Duloxetine 60mg daily for 14 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Benjamin Friedman, MD

Role: CONTACT

befriedm@montefiore.org

718-920-6626

Facility Contacts

Benjamin W Friedman, MD

Role: primary

befriedm@montefiore.org

718-920-6626

Other Identifiers

2023-14971

Identifier Type: -

Identifier Source: org_study_id