None listed
Conditions
Brief summary
This study aims to investigate whether the neuropathic pain medication pregabalin (Lyrica) is more effective than standard paracetamol in relieving pain and widespread neuropathic-type symptoms in individuals with mild to moderately painful knee osteoarthritis, who have been assessed for the additional presence of neuropathic pain.
Interventions
This study aims to investigate whether the neuropathic pain medication pregabalin (Lyrica) is more effective than standard paracetamol in relieving pain and widespread neuropathic-type symptoms in individuals with mild to moderately painful knee osteoarthritis, who have been assessed for the additional presence of neuropathic pain.
Participants will be randomly allocated to take either Lyrica (intervention) and placebo paracetamol (sugar pills) or 1000mg paracetamol four times daily (active con
This study aims to investigate whether the neuropathic pain medication pregabalin (Lyrica) is more effective than standard paracetamol in relieving pain and widespread neuropathic-type symptoms in individuals with mild to moderately painful knee osteoarthritis, who have been assessed for the additional presence of neuropathic pain. Participants will be randomly allocated to take either Lyrica (intervention) and placebo paracetamol (sugar pills) or 1000mg paracetamol four times daily (active control) and placebo Lyrica (sugar pills) daily for 28 days. The Lyrica dose will be titrated from 75mg daily to a potential maximum of 150mg over 14 days, dependent on individual tolerance level. All medications are to be taken orally. All patients will be issued with a medication diary in which clear instructions are provided for titrating medications. In addition to this, patients will receive regular telephone calls to ensure titration instructions are understood and adhered to. Research staff will work very closely with patients in this area. Note: Patients will be required to complete the medication diary with the number of tablets taken on each day. This will be returned at the end of the study along with any unused medication. At this point drug accountability will be performed by research staff before returning to Pharmacy, who will also monitor drug accountability.
Sponsors
Dr Robert Will
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed