Duloxetine for Osteoarthritis
(RELIFE Trial)
Trial Summary
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.
How does the drug Duloxetine differ from other treatments for osteoarthritis?
Duloxetine is unique for osteoarthritis treatment because it is primarily an antidepressant that works by affecting neurotransmitters (chemical messengers in the brain) to help reduce pain perception, unlike traditional treatments that focus on reducing inflammation or directly targeting joint pain.12345
What is the purpose of this trial?
Knee replacement surgery for osteoarthritis is a commonly performed procedure in Canada with 75,000 of these surgeries performed each year. Success rate for knee replacement surgery is high but more than 20% of patients are still dissatisfied mainly due to reports of ongoing pain. Pain control following knee surgery is important in order to allow patients to engage in recovery and rehabilitation. The current standard of pain management after surgery centers around the use of opioids which is a concerning practice as highlighted by the opioid epidemic. Duloxetine is an antidepressant that has pain relieving properties and it has been studied in patients undergoing knee replacement surgery. Studies to date have not been designed optimally to demonstrate the full effects of opioid dose reduction and the use of duloxetine as a medication following knee replacement surgery. This research study seeks to start duloxetine before surgery, at the recommended therapeutic dose, and for the duration of the early rehabilitation period. If the study is successful, this low-cost medication can improve satisfaction rates and change the standard way the pain management is typically carried out for patients undergoing the knee replacement surgery.
Eligibility Criteria
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
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
Treatment Details
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