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


- candidate number4205
- NTR NumberNTR1485
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2008
- Secondary IDs0801-38 
- Public TitleEffectiveness of Diclofenac versus Paracetamol in primary care patients with knee osteoarthritis.
- Scientific TitleEffectiveness of Diclofenac versus Paracetamol in primary care patients with knee osteoarthritis.
- ACRONYMN/A
- hypothesisWhat 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.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Knee, NSAID, Diclofenac, Paracetamol
- Inclusion criteria1. 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.
3. Have an indication for pain medication.
4. A score of 3 or more on the pain severity scale (0-10 scale).
5. Patientsí aged 45 years or older.
- Exclusion criteria1. 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.
3. Already taking NSAID or Paracetamol medication of similar or higher doses as in the study.
4. Surgery or major trauma of the affected joint within the previous 6 months.
5. Pregnancy.
6. Use of corticosteroid of hyaluronic acid.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-aug-2010
- Target number of participants154
- InterventionsTreatment 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.
- Primary outcomePain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS).
- Secondary outcome1. Patientsí perceived pain measured on a 11 point numerical rating scale (NRS) (0= no pain; 10= unbearable pain).
2. Patientsí quality of life using the EuroQol instrument EQ-5D.
3. All direct medical and patient costs (TIC-P Questionnaire) and indirect costs (PRODISQ).
4. Compliance to the therapy.
5. Co-interventions (e.g. changes in doses of co-medication).
6. Adverse reactions.
- TimepointsAll 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.
- Trial web sitehttp://www.erasmusmc.nl/huisartsgeneeskunde
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. P.A.J. Luijsterburg
- CONTACT for SCIENTIFIC QUERIESDr. P.A.J. Luijsterburg
- Sponsor/Initiator Erasmus Medical Center, Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryObjectives:
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).
- Main changes (audit trail)New Closingdate: 1- june-2012
- RECORD9-okt-2008 - 22-sep-2013


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