Duloxetine for Lower Back Pain

Phase 4

Recruiting

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Pain duration <2 weeks (336 hours).

Must not have

Contra-indication to duloxetine: alcohol use disorder, chronic liver disease, chronic kidney disease, glaucoma, Active use of medication for depression, Score >4 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide

Chronic pain syndrome defined as moderate or severe pain anywhere in their body on >50% of days for at least three months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 days, 16 days, 23 days, and 42 days after ed discharge

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will investigate if a drug can reduce chronic back pain. Patients with acute low back pain will be studied to see if duloxetine can help prevent it from lasting 3 months.

Who is the study for?

This trial is for adults aged 18-64 with recent non-radicular lower back pain that's bad enough to affect their daily life. They must not be pregnant, breastfeeding, or have allergies to the study medications. People with chronic liver or kidney disease, glaucoma, depression medication use, high suicide risk, chronic pain syndromes, severe heart failure or uncontrolled blood pressure are excluded.

What is being tested?

The study is testing if duloxetine can prevent long-term low back pain in patients who come to the ER with acute symptoms. Participants will receive either naproxen (a common anti-inflammatory drug) or duloxetine (usually used for depression and nerve pain) to see which one helps more.

What are the potential side effects?

Duloxetine may cause nausea, dry mouth, sleepiness, constipation and increased sweating. Naproxen might lead to stomach upset/pain, heartburn, headache and dizziness. Serious side effects could include liver damage from duloxetine and heart attack/stroke risks from naproxen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My back pain significantly affects my daily activities.

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My pain has lasted less than 2 weeks.

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My pain is not due to nerve damage.

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My lower back pain is due to muscle or bone issues, not injury or nerve problems.

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I went to the ER mainly for lower back pain, not including pain on the sides of my body.

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I am between 18 and 64 years old.

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I experienced back pain less than once a week before my recent severe episode.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have alcohol issues, liver or kidney disease, glaucoma, depression medication use, severe depression or suicidal thoughts.

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I have had moderate or severe pain most days for the last three months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 days, 16 days, 23 days, and 42 days after emergency department (ed) discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 days, 16 days, 23 days, and 42 days after emergency department (ed) discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 days, 16 days, 23 days, and 42 days after emergency department (ed) discharge for reporting.