Effectiveness of Diclofenac versus Paracetamol in primary care patients with knee osteoarthritis.

Objectives:
Therefore, the primary objective is to assess whether
there is a clinically relevant effectiveness of Diclofenac compared to
Paracetamol over a period of two weeks and if necessarily another two
weeks in new consulters with knee OA in the general practice.


Study design:
A randomized open label trial.


Study population:
154 primary care patients of 45 years and older consulting their general practitioner with a complaints of pain due to knee OA.


Intervention:
One group of patients (N=77) receives Diclofenac
(maximum daily dose of 150 mg) and the other group (N=77) receives
Paracetamol (maximum daily dose of 3000 mg) for a period of two weeks
and if necessarily another two weeks.

Main outcomes:
The primary outcomes are pain and function measured
with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

What is the effectiveness of Diclofenac compared to
Paracetamol over a period of two weeks and if necessarily another two
weeks (consistent with the Dutch guidelines for general practitioners)
in new consulters with knee osteoarthritis in the general practice.

All outcome measures will be obtained by a questionnaire at baseline and at 3,6, 9, and 12 weeks after randomization, with the exception of the outcome measures pain on the 11-point NRS and therapy compliance that will be assessed daily through a diary. Costs will only be obtained at 12 weeks follow-up.

Treatment with diclofenac (maximum daily dose of 150
mg) or Paracetamol (maximum daily dose of 3000 mg) for a period of two
weeks and if necessarily another two weeks.