Venlafaxine for pain reduction in patients with knee osteoarthritis

Phase 2

• Conditions: Chronic pain; Knee osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12619000878178
• Lead Sponsor: niversity of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-20
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in knee pain measured on the visual analog scale (VAS, 0-100 mm) over 12 weeks[Baseline, 4, 8 and 12 weeks post intervention commencement.]