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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21842

Enrollment

154

Registered

2008-10-09

Start date

2009-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis, pain, General Practitioner, NSAID, Paracetamol

Interventions

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.

Eligibility

Inclusion criteria

Inclusion criteria: 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. 3. Have an indication for pain medication. 4. A score of 3 or more on the pain severity scale (0-10 scale). 5. Patients’ aged 45 years or older.

Exclusion criteria

Exclusion criteria: 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. 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.

Design outcomes

Primary

Measure	Time frame
Pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS).	—

Secondary

Measure	Time frame
1. Patients’ perceived pain measured on a 11 point numerical rating scale (NRS) (0= no pain; 10= unbearable pain). 2. Patients’ 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.	—

Contacts

Public ContactP.A.J. Luijsterburg

Erasmus Medical Center Department of General Practice Room NA1905 PO Box 2040

p.luijsterburg@erasmusmc.nl+31 10 7037513

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)