Duloxetine for Lower Back Pain

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

Trial Summary

What is the purpose of this trial?

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.

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 evidence supports the effectiveness of the drug Duloxetine for lower back pain?

Research shows that Duloxetine significantly reduces pain in patients with chronic low back pain compared to a placebo, with improvements in overall health and quality of life. It is also effective for other chronic pain conditions like fibromyalgia and diabetic neuropathic pain, indicating its broader pain-relief capabilities. ^{1 2 3 4 5}

Is duloxetine safe for treating lower back pain?

Duloxetine is generally safe for treating chronic lower back pain, with common side effects including nausea and dry mouth. Studies show no significant difference in serious adverse events between duloxetine and placebo groups, although some patients may experience more minor side effects with higher doses. ^{1 2 6 7 8}

How does the drug duloxetine differ from other treatments for lower back pain?

Duloxetine is unique because it is a serotonin and norepinephrine reuptake inhibitor (SSNRI), which means it works by increasing the levels of certain chemicals in the brain that help reduce pain. It is taken as a once-daily pill and is effective for chronic low back pain, offering a non-opioid option with generally mild side effects. ^{1 2 3 7 9}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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, 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. [2022]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of duloxetine for chronic pain conditions. [2014]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Duloxetine 60 mg for chronic low back pain: post hoc responder analysis of double-blind, placebo-controlled trials. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Duloxetine: in patients with fibromyalgia. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Response to duloxetine in chronic low back pain: exploratory post hoc analysis of a Japanese Phase III randomized study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Duloxetine for the Treatment of Chronic Low Back Pain: A Systematic Review of Randomized Placebo-Controlled Trials. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Duloxetine and pregnancy outcomes: safety surveillance findings. [2023]

9. United States 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. [2015]