None listed
Conditions
Brief summary
Background: Osteoarthritis (OA) is a common, painful and disabling condition. Venlafaxine, a centrally acting antidepressant, has demonstrated analgesic effects in other chronic pain conditions. Primary aim: To determine the effectiveness, safety and tolerability of venlafaxine (75-150mg daily) compared to placebo in reducing pain in knee OA patients using a randomised, placebo-controlled double-blind design over 12-week. Primary hypothesis: Compared with placebo, in knee OA pain patients, 12-week treatment with venlafaxine will lead to a 10mm reduction in pain (assessed by 100mm visual analogue scale (VAS)). Significance and Innovation: Positive results will have a substantial and immediate impact on OA pain management. It will provide compelling evidence that venlafaxine can reduce pain in OA patients. Such findings can be easily translatable into clinical practice, as venlafaxine is low cost, well tolerated and currently available in Australia.
Interventions
Venlafaxine; 75 mg daily for 4 weeks and then increase to 150 mg daily for next 8 weeks; Tablet/oral administration; 12-week duration; Drug tablet return
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 40 to 80 years. 2. Knee pain for greater than or equal to 14 days of each month for >3 months. 3. Significant knee pain on most days (defined as a visual analogue scale (VAS) >40mm) on 100mm VAS pain. 4. Meet American College of Rheumatology (ACR) clinical criteria for knee OA confirmed by a rheumatologist.
Exclusion criteria
1. Severe knee OA (defined as joint space narrowing (JSN) on X-ray as Grade 3 using the OARSI atlas) 2. Prior knee joint replacement surgery. 3. Arthroscopy or open surgery in the study knee <12 months. 4. Intra-articular steroid injection <3 months. 5. Inflammatory arthritis (gout, rheumatoid arthritis, juvenile arthritis, etc). 6. Patients with a psychiatric disorder including major depressive disorder (Patient Health Questionnaire-9 score (PHQ-9)>9). 7. Contraindication to venlafaxine use including: • Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation; • Current use of opioid medication; • Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs). • History of seizures. • Current use of venlafaxine or other antidepressants, amiodarone or domperidone. • Pregnancy or breastfeeding. • High cholesterol (total cholesterol >13.3 mmol/l). • Hyponatremia (low amount of sodium in the blood <135 mmol/L). • Increased risk of bleeding due to clotting disorder; • History of increased intra-ocular pressure or closed angle glaucoma. • Severe uncontrolled high blood pressure (supine diastolic blood pressure (SDBP) greater than or equal to 90 mm Hg). • Heart attack within the last 3 months. • Cirrhosis of the liver or abnormal liver function (alanine transaminase (ALT) 3x upper normal limit). • Mild to moderate kidney impairment (estimated glomerular filtration rate (eGFR) <89 ml/min per 1.73 m2). 8. Inability to provide informed consent.
Outcome results
None listed