None listed
Conditions
Brief summary
Medications commonly used to treat osteoarthritis pain remain ineffective or poorly tolerated. Anti-depressant medications can also be used to treat pain and have recently been trialled in people with knee osteoarthritis. While promising, the specific medication tested (Duloxetine) is not approved or subsidised in New Zealand and its effects are not consistent across individuals – some people experience substantial pain relief while others receive no meaningful benefit. This study aims to compare the effectiveness of Duloxetine to a similar, cheaper medication called Venlafaxine for the treatment of knee osteoarthritis pain. In addition, we will test the function of specific pain pathways before treatment, to see if we can predict which individuals will benefit most from these medications. Findings from this research may provide evidence for a new medication in the treatment of osteoarthritis pain and allow doctors to better individualise pain treatment, matching medications to the underlying cause of a person's pain.
Interventions
Inert gelatin placebo taken orally once a day in 1 opaque microcellulose capsule for 1 week; Venlafaxine (75mg) taken orally once a day in 1 opaque microcellulose capsule for 1 week; Venlafaxine (150mg) taken orally once a day in 1 opaque microcellulose capsules for 7 weeks (trial endpoint); Venlafaxine (75mg) taken orally once a day in 1 opaque microcellulose capsule for 2 weeks (tapering dose). Participant adherence will be monitored through the use of daily drug diaries, weekly follow up phon
Inert gelatin placebo taken orally once a day in 1 opaque microcellulose capsule for 1 week; Venlafaxine (75mg) taken orally once a day in 1 opaque microcellulose capsule for 1 week; Venlafaxine (150mg) taken orally once a day in 1 opaque microcellulose capsules for 7 weeks (trial endpoint); Venlafaxine (75mg) taken orally once a day in 1 opaque microcellulose capsule for 2 weeks (tapering dose). Participant adherence will be monitored through the use of daily drug diaries, weekly follow up phone calls and the return of any unused medications at the end of the intervention period.
Sponsors
Waitemata District Health Board
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 No maximum
Healthy volunteers
No
Inclusion criteria
Males and females at least 40 years old who have radiographic evidence of knee osteoarthritis and meet the American College of Rheumatology clinical criteria for the diagnosis of knee osteoarthritis. A history of knee pain for > 14 days days of each month for 3 months or more. A brief pain inventory average pain rating of at least 4/10 at the time of initial screening
Exclusion criteria
Current use of antidepressant medication or any other medication with a serotonergic effect; use of a MAOI inhibitor in the last 14 days; narrow-angle glaucoma; BMI > or = to 40; diagnosis of any other type of arthritis; joint injection or surgery on the index knee within the last 3 months; impending surgery in the next 3 months; medical contraindication to the use of rescue medications (acetaminophen and NSAIDs); patients taking any excluded medications that cannot be discontinued; women who are pregnant, breast feeding or planning to get pregnant; previous diagnosis of a major psychiatric disorder; history of alcoholism; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 100 IU/L or total bilirubin > 27.4 umol/L; glomerular filtration rate of < 30ml/min; a history of myocardial infarction in the last 12 months, QTc interval > 500ms, unstable coronary artery disease or recent unexplained cardiac symptoms; uncontrolled hypertension (> or = to 140mmHg systolic or > or = to 90mmHg diastolic BP); a history of seizures; a history of multiple falls in the last 12 months; current use of warfarin; an inability to perform psychophysical testing.
Outcome results
None listed