Duloxetine for Lower Back Pain

Recruiting at 1 trial location

Overseen By Benjamin Friedman

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must not be taking: Anticoagulants, Antidepressants

Disqualifiers: Pregnancy, Chronic pain, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if duloxetine, when combined with naproxen, can improve lower back pain compared to naproxen with a placebo. It focuses on individuals who have experienced functionally impairing back pain for less than two weeks and received treatment in the emergency room. Eligible participants should have musculoskeletal back pain that does not radiate down the legs and has not been a frequent issue before the recent pain. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively using medication for depression.

What is the safety track record for duloxetine?

Research has shown that duloxetine is generally safe for treating long-term lower back pain. Studies have found that a 60 mg dose taken once daily is effective and usually well-tolerated. Common side effects include nausea, dry mouth, and dizziness, but these are typically mild and manageable. The FDA has already approved duloxetine for other uses, indicating a well-established safety record. Overall, duloxetine can be a safe option for those with back pain, but discussing potential side effects with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using duloxetine for lower back pain because it works differently than typical pain relievers. While most treatments for lower back pain, like NSAIDs such as naproxen, mainly target inflammation, duloxetine is an antidepressant that acts on the central nervous system. It increases the levels of neurotransmitters like serotonin and norepinephrine, which can help reduce pain perception. This unique mechanism offers a new way to manage pain, potentially benefiting patients who haven’t found relief with standard painkillers.

What evidence suggests that duloxetine might be an effective treatment for lower back pain?

Research has shown that duloxetine, one of the treatments in this trial, effectively treats chronic low back pain. Studies have found that duloxetine significantly reduces pain levels. In one study, 16.5% of patients taking duloxetine experienced better results compared to those taking a placebo, highlighting its potential benefits. In this trial, some participants will receive a combination of Naproxen and duloxetine, while others will receive Naproxen with a placebo. Duloxetine is also recommended when other pain relief medicines, like NSAIDs (non-steroidal anti-inflammatory drugs), don't work. This medication has also been helpful for other types of pain, such as nerve pain. Overall, duloxetine has a proven track record of improving pain conditions. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My back pain significantly affects my daily activities.

My pain has lasted less than 2 weeks.

My pain is not due to nerve damage.

Exclusion Criteria

Allergic to or intolerant of investigational medications

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

I do not have allergies to NSAIDs, stomach ulcers, severe heart failure, uncontrolled high blood pressure, kidney issues, use blood thinners, or have liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive duloxetine or placebo in addition to naproxen for pain management

6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Duloxetine

Trial Overview 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.

How Is the Trial Designed?

Group I: Naproxen + duloxetine Experimental Treatment 2 Interventions

Group II: Naproxen + placebo Placebo Group 1 Intervention

Duloxetine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cymbalta for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Fibromyalgia
• Neuropathic Pain
• Chronic Musculoskeletal Pain

Approved in European Union as Cymbalta / Yentreve for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Diabetic Peripheral Neuropathic Pain
• Fibromyalgia
• Stress Urinary Incontinence

Approved in Canada as Cymbalta for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Fibromyalgia
• Neuropathic Pain
• Chronic Musculoskeletal Pain

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

Duloxetine significantly reduced chronic low back pain (CLBP) in patients, with 59.7% achieving at least a 30% pain reduction compared to 47.8% in the placebo group, based on a pooled analysis of 4 trials involving 1295 participants over 12-14 weeks.

Patients who experienced early pain improvement (≥15% reduction at Week 2) were much more likely to achieve greater pain reductions, and those with multiple painful sites benefited more from duloxetine than those with isolated CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine 60 mg for chronic low back pain: post hoc responder analysis of double-blind, placebo-controlled trials. Alev, L., Fujikoshi, S., Yoshikawa, A., et al.[2020]

An analysis of pregnancy outcomes from 400 cases involving duloxetine showed that 143 resulted in normal outcomes, while 90 were abnormal, primarily consisting of spontaneous abortions and premature births, indicating potential risks associated with its use during pregnancy.

The data from both the Lilly Safety System and the FDA Adverse Events Reporting System suggest that the rates of abnormal pregnancy outcomes in duloxetine cases are generally consistent with historical rates in the general population, implying that duloxetine may not significantly increase the risk of adverse pregnancy outcomes compared to other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine and pregnancy outcomes: safety surveillance findings. Hoog, SL., Cheng, Y., Elpers, J., et al.[2023]

Duloxetine is an effective nonopioid analgesic for chronic pain conditions, including diabetic peripheral neuropathic pain, fibromyalgia, chronic low back pain, and osteoarthritis, showing comparable efficacy to other common pain medications.

Most side effects from duloxetine are mild to moderate and typically occur early in treatment, suggesting a favorable safety profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of duloxetine for chronic pain conditions. Mease, PJ., Walker, DJ., Alaka, K.[2014]

In a 12-week study involving 30 older adults, duloxetine combined with Depression and Pain Care Management (DPCM) led to a 46.7% remission rate in major depressive disorder (MDD) and a 93.3% significant pain response in chronic low back pain (CLBP).

The average time to achieve depression remission was about 7.6 weeks, while pain response was quicker at 2.8 weeks, indicating that this treatment approach effectively addresses both conditions in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study. Karp, JF., Weiner, DK., Dew, MA., et al.[2022]

Duloxetine, at a dosage of 60 mg once daily, has been shown to be effective in managing chronic pain conditions such as diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain associated with osteoarthritis and low back pain, based on a review of 30 clinical studies.

The medication's dual action on serotonin and norepinephrine reuptake may make it a versatile treatment option for patients who experience both chronic pain and comorbid conditions like major depressive disorder or generalized anxiety disorder, provided that safety guidelines are followed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of duloxetine 60 mg once-daily dosing for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis pain and low back pain. Pergolizzi, JV., Raffa, RB., Taylor, R., et al.[2015]

Duloxetine is an effective first-line treatment for chronic low back pain (CLBP), showing statistically significant improvements in pain and disability scores compared to placebo in five studies involving 832 patients.

The most effective dosage was found to be 60 mg daily, which improved pain without a significant increase in serious adverse events, indicating it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine for the Treatment of Chronic Low Back Pain: A Systematic Review of Randomized Placebo-Controlled Trials. Hirase, T., Hirase, J., Ling, J., et al.[2021]

In a study of 456 patients with chronic low back pain, those who experienced early pain reduction of 30% or more while taking duloxetine showed significantly greater improvements in pain and quality of life compared to those on placebo.

Patients who experienced treatment-related adverse events, such as nausea or somnolence, also had better responses to duloxetine, suggesting that early indicators of treatment response can help identify patients likely to benefit from this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to duloxetine in chronic low back pain: exploratory post hoc analysis of a Japanese Phase III randomized study. Tsuji, T., Itoh, N., Ishida, M., et al.[2022]

In a study involving 401 adults with chronic low back pain, duloxetine (60 mg daily) significantly reduced average pain levels compared to placebo, demonstrating its efficacy in managing this condition.

While duloxetine was effective, it also had a higher rate of adverse events leading to discontinuation (15.2% vs. 5.4% for placebo), with nausea and dry mouth being the most common side effects, highlighting the importance of monitoring safety in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. Skljarevski, V., Zhang, S., Desaiah, D., et al.[2022]

In two phase III studies, duloxetine 60 mg/day significantly reduced average pain severity and improved patient-reported outcomes in fibromyalgia patients compared to placebo, demonstrating its efficacy in managing pain.

Despite initial improvements, a longer 27-week trial showed no significant difference between duloxetine and placebo for pain scores, and increasing the dose to 120 mg/day did not enhance response in nonresponders, indicating a limit to its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine: in patients with fibromyalgia. Curran, MP.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8140818/

Duloxetine for the Treatment of Chronic Low Back Pain All five studies reported statistically significant improvements in more than one back-pain-specific clinical outcome score with duloxetine ...

2. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/212516s002lbl.pdf

drizalma sprinkle - accessdata.fda.gov Chronic Low Back Pain: Approximately 16.5% (99/600) of the duloxetine delayed-release capsules-treated patients in 13 week, placebo-controlled adulttrials for ...

3. psychopharmacologyinstitute.com psychopharmacologyinstitute.com/publication/duloxetine-guide-pharmacology-indications-dosing-guidelines-and-adverse-effects-2902/

Duloxetine Guide: Pharmacology, Indications, Dosing ... Effective for both chronic low back pain and osteoarthritis. Recommended as an alternative when NSAIDs are contraindicated or ineffective.

4. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/jan-2024-durb-agenda-item5p.pdf

Neuropathic Pain Therapeutic Class Review (TCR) The safety and effectiveness of duloxetine (Cymbalta, Drizalma Sprinkle) in the management of diabetic peripheral neuropathy in patients ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19469829/

A double-blind, randomized trial of duloxetine versus ... Duloxetine 60 mg was superior to placebo from weeks 3-11 in relieving pain, but not at weeks 12-13. Duloxetine 60 mg demonstrated significant improvement.

6. mayoclinic.org mayoclinic.org/drugs-supplements/duloxetine-oral-route/description/drg-20067247

Duloxetine (oral route) - Side effects & dosage Duloxetine is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy).

7. reference.medscape.com reference.medscape.com/drug/cymbalta-irenka-duloxetine-342960

Cymbalta, Drizalma Sprinkle - duloxetine (Rx) Chronic Musculoskeletal Pain. Indicated for chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. 30 mg PO qDay ...