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

Table 1 Inclusion and exclusion criteria of the DIPA trial.

Inclusion Criteria	Exclusion Criteria
People with a new episode of non-traumatic knee pain	Contra-indication for NSAID or acetaminophen
Age ≥ 45 years	Arthroplasty/osteotomy
Comply with the clinical ACR criteria*	Already on NSAID or acetaminophen use^
Pain severity scale ≥ 2 on a 11-point numeric rating scale	Surgery or major trauma of affected knee in previous 6 months
	Oral corticosteroid use
	Myocardial infarction or stroke in previous 6 months

*Clinical ACR criteria: Age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth. Patients comply with the clinical ACR criteria if they meet at least 3 of the 6 criteria.
^Excluded are those with a pre-study medication use comparable with the study dose of diclofenac (≥ 150 mg/day) or acetaminophen (≥ 3000 mg/day)

ISSN: 1471-2474