Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial
<p>Abstract</p> <p>Background</p> <p>Osteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee. According to international guidelines and the Dutch general practitioners guidelines for non-traumatic knee sympto...
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| Format: | Article |
| Language: | English |
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BMC
2010-01-01
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| Series: | BMC Musculoskeletal Disorders |
| Online Access: | http://www.biomedcentral.com/1471-2474/11/7 |
| _version_ | 1818808241831804928 |
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| author | Bohnen Arthur M Koes Bart W Luijsterburg Pim AJ Verkleij Saskia PJ Bierma-Zeinstra Sita MA |
| author_facet | Bohnen Arthur M Koes Bart W Luijsterburg Pim AJ Verkleij Saskia PJ Bierma-Zeinstra Sita MA |
| author_sort | Bohnen Arthur M |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Osteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee. According to international guidelines and the Dutch general practitioners guidelines for non-traumatic knee symptoms, acetaminophen should be the pain medication of first choice for osteoarthritis. However, of all prescribed pain medication in general practice, 90% consists of non-steroidal anti-inflammatory drugs compared to 10% of acetaminophen. Because general practitioners may lack evidence showing a similar efficacy of acetaminophen and non-steroidal anti-inflammatory drugs, we present the design of a randomized open-label trial to investigate the efficacy of a non-steroidal anti-inflammatory drug (diclofenac) compared with acetaminophen in new consulters with knee osteoarthritis in general practice.</p> <p>Methods/Design</p> <p>Patients aged 45 years or older consulting their general practitioner with non-traumatic knee pain, meeting the clinical American College of Rheumatology criteria, and with a pain severity score of 2 or higher (on a 0-10 scale), will be randomly allocated to either diclofenac (maximum daily dose of 150 mg) or acetaminophen (maximum daily dose of 3000 mg) for 2 weeks and, if required, an additional 1-2 weeks, with a total follow-up period of 12 weeks. The primary outcomes are knee pain measured with a daily diary, and pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and at 3, 6, 9, and 12-weeks follow-up. Secondary outcomes are patients' perceived recovery, quality of life, medical, patient, and productivity costs, compliance to therapy, co-interventions, and adverse reactions.</p> <p>Discussion</p> <p>The successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis.</p> <p>Trial registration</p> <p>Dutch trial registry NTR1485.</p> |
| first_indexed | 2024-12-18T19:38:26Z |
| format | Article |
| id | doaj.art-308da5ffbdd541fdbad1bbe07a156e5e |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-12-18T19:38:26Z |
| publishDate | 2010-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-308da5ffbdd541fdbad1bbe07a156e5e2022-12-21T20:55:31ZengBMCBMC Musculoskeletal Disorders1471-24742010-01-01111710.1186/1471-2474-11-7Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trialBohnen Arthur MKoes Bart WLuijsterburg Pim AJVerkleij Saskia PJBierma-Zeinstra Sita MA<p>Abstract</p> <p>Background</p> <p>Osteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee. According to international guidelines and the Dutch general practitioners guidelines for non-traumatic knee symptoms, acetaminophen should be the pain medication of first choice for osteoarthritis. However, of all prescribed pain medication in general practice, 90% consists of non-steroidal anti-inflammatory drugs compared to 10% of acetaminophen. Because general practitioners may lack evidence showing a similar efficacy of acetaminophen and non-steroidal anti-inflammatory drugs, we present the design of a randomized open-label trial to investigate the efficacy of a non-steroidal anti-inflammatory drug (diclofenac) compared with acetaminophen in new consulters with knee osteoarthritis in general practice.</p> <p>Methods/Design</p> <p>Patients aged 45 years or older consulting their general practitioner with non-traumatic knee pain, meeting the clinical American College of Rheumatology criteria, and with a pain severity score of 2 or higher (on a 0-10 scale), will be randomly allocated to either diclofenac (maximum daily dose of 150 mg) or acetaminophen (maximum daily dose of 3000 mg) for 2 weeks and, if required, an additional 1-2 weeks, with a total follow-up period of 12 weeks. The primary outcomes are knee pain measured with a daily diary, and pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and at 3, 6, 9, and 12-weeks follow-up. Secondary outcomes are patients' perceived recovery, quality of life, medical, patient, and productivity costs, compliance to therapy, co-interventions, and adverse reactions.</p> <p>Discussion</p> <p>The successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis.</p> <p>Trial registration</p> <p>Dutch trial registry NTR1485.</p>http://www.biomedcentral.com/1471-2474/11/7 |
| spellingShingle | Bohnen Arthur M Koes Bart W Luijsterburg Pim AJ Verkleij Saskia PJ Bierma-Zeinstra Sita MA Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial BMC Musculoskeletal Disorders |
| title | Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial |
| title_full | Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial |
| title_fullStr | Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial |
| title_full_unstemmed | Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial |
| title_short | Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial |
| title_sort | effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis ntr1485 dipa trial design of a randomized clinical trial |
| url | http://www.biomedcentral.com/1471-2474/11/7 |
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