A randomized, blinded, comparator-controlled trial investigating a 28-day course of Lyrica in participants with knee osteoarthritis who exhibit neuropathic pain, compared with a 28-day course of acetaminophen.
- Conditions
- OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12613000840785
- Lead Sponsor
- Dr Robert Will
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 90
Unilateral diagnosis of knee OA greater than 6 months duration, according to the American College of Rheumatology clinical classification system (diagnosis performed by an experienced Rheumatologist (Dr Will) based on radiological & clinical presentation); Pain in the index knee greater than or equal to 4 out of 10 with an additional 1-1.5 out of 10 increase in pain on walking when withdrawn from their usual analgesic medication; No additional clinically significant joint involvement and otherwise in good health; American Rheumatology Association functional Class I, II or III; No recent arthroscopy, injections with glucocorticoid or hyaluronan in last 6 months to index knee; No plan for joint replacement surgery during the study period.
History of other systemic inflammatory conditions; neurological deficits (motor, cognitive or sensory); recent lower limb injury or surgery (< 6 months); history of other chronic pain disorders (eg fibromyalgia); skin allergies; history of allergic reaction to pregabalin / gabapentin / acetaminophen; ASA of IV; severe hepatic dysfunction (serum albumin <25g/l); congestive heart failure; chronic renal failure; pregnancy; breast feeding;
compromised creatinine clearance (<30mL/min); hereditary
problems with galactose metabolism; History of severe depression or currently on medication for depression or anxiety.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method