150 Participants Needed

Duloxetine for Osteoarthritis

(RELIFE Trial)

HM
SC
SC
ST
Overseen BySebastian Tomescu, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Sunnybrook Health Sciences Centre
Must be taking: Duloxetine
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

I have knee osteoarthritis.
I am scheduled for knee replacement surgery on one knee.
I am 50 years old or older.
See 1 more

Exclusion Criteria

Involved in worker's compensation case/law suit (verbally declared by patient)
I am currently taking triptan or lithium.
Lack of patient consent; unlikely to comply with follow-up
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive duloxetine 60mg once daily for 2 weeks before surgery

2 weeks
1 visit (in-person) for baseline assessments

Postoperative Treatment

Participants continue duloxetine 60mg once daily for 6 weeks after surgery

6 weeks
3 visits (in-person) at 1, 6, and 12 weeks post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Assessments at 6 and 12 weeks post-surgery

Treatment Details

Interventions

  • Duloxetine
Trial Overview This trial tests whether taking Duloxetine (an antidepressant with pain-relieving properties) before and after knee replacement surgery can reduce the need for opioids during recovery compared to a placebo. The goal is to improve post-surgery satisfaction by optimizing pain management.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery.
Group II: ControlPlacebo Group1 Intervention
Placebo OD for 2 weeks preoperatively then OD for 6 weeks post-surgery.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

References

Efficacy of needle-knife combined with etanercept treatment regarding disease activity and hip joint function in ankylosing spondylitis patients with hip joint involvement: A randomized controlled study. [2020]
Canadian Rheumatology Association Consensus on the use of anti-tumor necrosis factor-alpha directed therapies in the treatment of spondyloarthritis. [2015]
Effect of etanercept and entecavil in a patient with rheumatoid arthritis who is a hepatitis B carrier: a review of the literature. [2021]
Etanercept: in ankylosing spondylitis. [2018]
Efficacy of SLZ and MTX (alone or combination) on the treatment of active sacroiliitis in early AS. [2022]
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