No registrations found.
ID
Source
Brief title
Health condition
Knee osteoarthritis, pain, General Practitioner, NSAID, Paracetamol
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain and function measured with the Knee Injury and
Osteoarthritis Outcome Score (KOOS).
Secondary outcome
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.
Background summary
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).
Study objective
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.
Study design
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.
Intervention
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.
Department of General Practice<br>
Room NA1905<br>
PO Box 2040<br>
P.A.J. Luijsterburg
Rotterdam 3000 CA
The Netherlands
+31 10 7037513
p.luijsterburg@erasmusmc.nl
Department of General Practice<br>
Room NA1905<br>
PO Box 2040<br>
P.A.J. Luijsterburg
Rotterdam 3000 CA
The Netherlands
+31 10 7037513
p.luijsterburg@erasmusmc.nl
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1425 |
| NTR-old | NTR1485 |
| Other | - : 0801-38 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |