Duloxetine for LBP

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05851976
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain, Low	Drug: Naproxen; Drug: Duloxetine	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: May 1, 2026
• Anticipated Study Completion Date: Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naproxen + duloxetine	Drug: Naproxen; Naproxen 500mg twice daily for 16 days; Drug: Duloxetine; Duloxetine 60mg daily for 14 days
Placebo Comparator: Naproxen + placebo	Drug: Naproxen; Naproxen 500mg twice daily for 16 days

Outcome Measures

Primary Outcome Measures

1. Number of participants with Moderate or severe pain [6 weeks]

   An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous week.

2. Number of participants with Moderate or severe pain [16 days]

   An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous 24 hours.

3. Number of participants with Moderate or severe pain [3 months]

   An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used. Study participants will be asked to describe their worst back pain in the previous week.

Secondary Outcome Measures

1. Number of Participants demonstrating improvement based on Roland Morris Disability Questionnaire results [6 weeks]

   This 24-item lower back pain (LBP) functional scale is recommended for use in LBP research. Items are scored 0 if left blank or 1 if endorsed, for a total Roland Morris score ranging from 0-24. Higher scores represent higher levels of pain-related disability.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 >4 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT05851976
• Other Study ID Numbers: 2023-14971
• First Posted: May 10, 2023
• Last Update Posted: May 10, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Naproxen; Duloxetine Hydrochloride

Study Results

No Results Posted as of May 10, 2023