Effectiveness of Diclofenac versus Paracetamol in primary care patients with knee osteoarthritis.
- Conditions
- Knee osteoarthritis, pain, General Practitioner, NSAID, Paracetamol
- Registration Number
- NL-OMON21842
- Lead Sponsor
- Erasmus MC, Department of general practice
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 154
1. Patients consulting for a new episode with non-traumatic knee pain in the general practice.
2. Complying to the clinical American College of Rheumatology (ACR) criteria for osteoarthrosis of the knee.
1. Contra-indication for NSAID or Paracetamol use (these are: Gastrointestinal bleedings in history or active, blood dyscrasia, bone marrow depression, serious heart failure, serious liver or kidney disease (glomerular filtration < 30 ml/min), known alcoholism, Colitis Ulcerosa, Crown disease, sulphite hypersensitivity, appearance of asthma, urticaria, angioedema, nasal polyps or rhinitis after use of acetylsalicylic acid or other prostaglandin synthetase inhibitors, or use of anti-depressives (SSRIs).
2. An arthroplasty or osteotomy of the knee in contralateral or unilateral side.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain and function measured with the Knee Injury and <br>Osteoarthritis Outcome Score (KOOS).<br><br><br>
- Secondary Outcome Measures
Name Time Method 1.Patients’ perceived pain measured on a 11 point numerical rating scale (NRS) (0= no <br>pain; 10= unbearable pain).<br /><br>2.Patients’ quality of life using the EuroQol instrument EQ-5D.<br /><br>3.All direct medical and patient costs (TIC-P Questionnaire) and indirect costs (PRODISQ).<br /><br>4.Compliance to the therapy.<br /><br>5.Co-interventions (e.g. changes in doses of co-medication).<br /><br>6.Adverse reactions.<br>