Abstract
BackgroundOsteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee. According to international guidelines and the Dutch general practitioners guidelines for non-traumatic knee symptoms, acetaminophen should be the pain medication of first choice for osteoarthritis. However, of all prescribed pain medication in general practice, 90% consists of non-steroidal anti-inflammatory drugs compared to 10% of acetaminophen. Because general practitioners may lack evidence showing a similar efficacy of acetaminophen and non-steroidal anti-inflammatory drugs, we present the design of a randomized open-label trial to investigate the efficacy of a non-steroidal anti-inflammatory drug (diclofenac) compared with acetaminophen in new consulters with knee osteoarthritis in general practice.Methods/DesignPatients aged 45 years or older consulting their general practitioner with non-traumatic knee pain, meeting the clinical American College of Rheumatology criteria, and with a pain severity score of 2 or higher (on a 0-10 scale), will be randomly allocated to either diclofenac (maximum daily dose of 150 mg) or acetaminophen (maximum daily dose of 3000 mg) for 2 weeks and, if required, an additional 1-2 weeks, with a total follow-up period of 12 weeks. The primary outcomes are knee pain measured with a daily diary, and pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and at 3, 6, 9, and 12-weeks follow-up. Secondary outcomes are patients' perceived recovery, quality of life, medical, patient, and productivity costs, compliance to therapy, co-interventions, and adverse reactions.DiscussionThe successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis.Trial registrationDutch trial registry NTR1485.
Highlights
Osteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee
The successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis
* Correspondence: s.verkleij@erasmusmc.nl Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Netherlands prospective cohort of first consulters with non-traumatic knee symptoms in 40 Dutch general practices showed that general practitioner (GP) prescribed pain medication in 27% of these patients, 90% received non-steroidal anti-inflammatory drugs (NSAIDs) and only 10% received acetaminophen
Summary
Osteoarthritis (OA) is the most frequent chronic joint disease causing pain and disability of especially hip and knee [1]. A systematic review of 15 randomized clinical trials (RCTs; median length 6 weeks) on the comparative effectiveness of NSAIDs versus acetaminophen in patients with hip/knee OA reported that acetaminophen was more effective than placebo, it provided less pain relief than NSAIDs [5]. One trial reported (not surprisingly) that prior use of NSAIDs predicted a better response of NSAIDs compared to acetaminophen [8] These latter studies do not represent patients with OA in general practice, or patients who consult their GP for the first time with a new episode of complaints. In view of the lack of trials comparing the efficacy of NSAIDs with acetaminophen in new consulters with OA, we designed an RCT to explore whether there is a clinically relevant difference between diclofenac (an NSAID) and acetaminophen in new patients with knee OA in general practice. Presented below is the protocol of the diclofenac versus acetaminophen trial (DIPA trial), which is registered in the Dutch trial registry (NTR1485) [11]
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