| NCT ID | NCT05851976 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Montefiore Medical Center |
| Condition | Back Pain, Low |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-10-04 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2023-10-04 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Benjamin Friedman, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05851976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Back Pain, Low. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05851976 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05851976 currently recruiting?
Yes, NCT05851976 is actively recruiting participants. Contact the research team at befriedm@montefiore.org for enrollment information.
Where is the NCT05851976 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05851976 clinical trial?
NCT05851976 is sponsored by Montefiore Medical Center. The principal investigator is Benjamin Friedman, MD at Montefiore Medical Center. The trial plans to enroll 120 participants.