Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-trial: design of a randomized clinical trial.
BACKGROUND
Osteoarthritis 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
Patients 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.


CONCLUSIONS
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.


BACKGROUND
Dutch trial registry NTR1485.
Verkleij
Saskia P J
SP
Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Netherlands. s.verkleij@erasmusmc.nl
Luijsterburg
Pim A J
PA
Koes
Bart W
BW
Bohnen
Arthur M
AM
Bierma-Zeinstra
Sita M A
SM
D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D018771:Arthralgia / Q000188:drug therapy; D002985:Clinical Protocols; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement / Q000379:methods; D010349:Patient Compliance; D017060:Patient Satisfaction; D018579:Patient Selection; D011320:Primary Health Care / Q000379:methods / Q000706:statistics & numerical data; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D000082:Acetaminophen