Duloxetine for Osteoarthritis
(RELIFE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether duloxetine, a medication typically used for depression, can manage pain after knee replacement surgery for osteoarthritis. The researchers aim to determine if it offers a better alternative to opioids, which have concerning side effects, especially amid the opioid epidemic. Participants will receive either duloxetine or a placebo (a substance with no active medicine) before and after surgery to assess improvements in pain relief and recovery. This trial suits individuals aged 50 and older with knee osteoarthritis who plan to undergo knee replacement surgery. As a Phase 4 trial, duloxetine is already FDA-approved and proven effective; this research seeks to understand its benefits for more patients, offering a chance to contribute to broader pain management solutions.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including some antidepressants, specific antibiotics, and medications like thioridazine. If you're on any of these, you may need to stop them to participate.
What is the safety track record for this treatment?
Research has shown that duloxetine is generally well-tolerated for treating osteoarthritis pain. Studies have found it can reduce pain and improve movement in people with knee osteoarthritis. In one study, about 16% of patients experienced some side effects, but these were usually mild. Another study confirmed that duloxetine is a safe option for improving pain and movement in osteoarthritis patients. Although primarily used as an antidepressant, duloxetine's ability to relieve pain makes it a promising choice for managing pain without opioids.12345
Why are researchers enthusiastic about this study treatment?
Duloxetine is unique because it offers a novel approach to managing osteoarthritis pain by targeting the central nervous system, unlike traditional treatments like NSAIDs or corticosteroids, which mainly focus on reducing inflammation and pain at the site. Most osteoarthritis treatments work locally on the joints, but duloxetine, typically used as an antidepressant, affects neurotransmitters like serotonin and norepinephrine, which can help alter the perception of pain. Researchers are excited about duloxetine because it may offer pain relief for osteoarthritis patients who do not respond well to standard anti-inflammatory medications, potentially improving their quality of life without the gastrointestinal side effects often associated with other pain medications.
What evidence suggests that duloxetine might be an effective treatment for osteoarthritis?
Research shows that duloxetine, which participants in this trial may receive, helps reduce pain and improve movement in people with knee osteoarthritis. Studies have found that duloxetine eases pain more effectively than a placebo. Many patients report significant improvement after taking duloxetine. It is considered a safe and effective way to manage osteoarthritis pain. Duloxetine's ability to relieve pain and improve joint movement makes it a promising option for those undergoing knee replacement surgery.16789
Are You a Good Fit for This Trial?
The RELIFE trial is for individuals with osteoarthritis undergoing total knee replacement surgery. Participants should not have used opioids or antidepressants recently, and must be able to take oral medication. They are excluded if they have chronic pain disorders other than osteoarthritis, a history of substance abuse, or conditions that interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Treatment
Participants receive duloxetine 60mg once daily for 2 weeks before surgery
Postoperative Treatment
Participants continue duloxetine 60mg once daily for 6 weeks after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Duloxetine
Duloxetine is already approved in United States, European Union, Canada for the following indications:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Diabetic Peripheral Neuropathic Pain
- Fibromyalgia
- Stress Urinary Incontinence
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor