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02 September 2010
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| [ Print-friendly version ] |
| Topical or Oral Ibuprofen |
| ISRCTN | ISRCTN79353052 |
| ClinicalTrials.gov identifier | |
| Public title | Topical or Oral Ibuprofen |
| Scientific title | Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain in older people? |
| Acronym | TOIB |
| Serial number at source | HTA 01/09/02 |
| Study hypothesis |
1. To ascertain, for older people with knee pain, if oral and topical ibuprofen are equally effective at reducing pain and disability in a randomised controlled trial
2. To compare the incidence of adverse effects from oral and topical ibuprofen used to treat older people with knee pain 3. To compare the cost effectiveness of oral and topical ibuprofen used for treatment of older people with knee pain 4. To compare expected and actual satisfaction with treatment, with effectiveness of oral and topical ibuprofen for older people with knee pain 5. To explore how older people's expressed preferences for, and previous use of, oral or topical medication for chronic knee pain influences treatment effectiveness 6. To explore older people's beliefs about and expectations of treatments for chronic knee pain |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Knee pain |
| Participants - inclusion criteria |
1. Aged 50 or over
2. Have ever had pain in or around the knee on most days for at least a month and have experienced knee pain for more than three months out of the preceding year 3. General Practitioner (GP) consultation, or treatment, for knee pain in the preceding three years 4. Informed consent 5. Agreement to use chosen or allocated treatment 6. GP agreement to prescribe oral/topical ibuprofen 7. Ability to complete postal questionnaires |
| Participants - exclusion criteria |
1. Peptic ulceration (past or current)
2. Current moderate or severe indigestion 3. Previous severe adverse reaction to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 4. Hypertension (systolic Blood Pressure [BP] of 155 mmHg or more or a diastolic BP of 105 mmHg or more) 5. Uncontrolled heart failure 6. Creatinine greater than 140 mmol/L 7. Abnormal liver function sufficient to contraindicate use of NSAIDs (as liver function tests performed and reference ranges vary between different laboratories, this decision is at the discretion of the participant's GP) 8. GP request not to include 9. Serious psychological or psychiatric disorders (including dementia) 10. Previous knee replacement/s or awaiting knee surgery 11. Inflammatory arthropathy 12. Pain referred from hip or back 13. Serious injury within six months 14. Currently on anticoagulants or oral steroids 15. Anaemia (Haemoglobin [Hb] less than 12.4 g/L for men or less than 11.8 g/L for women) 16. Disseminated malignancy To meet the American College of Rheumatologists (ACR) clinical criteria for osteoarthritis of the knee, patients need to have knee pain, as defined for this study, and meet three out of the following six criteria: 1. Aged over fifty 2. Less than 30 minutes morning stiffness 3. Crepitus 4. Bony tenderness 5. Bony enlargement 6. No palpable warmth |
| Anticipated start date | 01/07/2002 |
| Anticipated end date | 31/08/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 283 |
| Interventions |
The two interventions being compared are the GP's recommendation (either a prescription or advice to get an over-the-counter preparation) to use either topical or oral ibuprofen. For those whose chosen/allocated treatment is oral ibuprofen, practices are asked to use no more than 1.2 g per day. Treatments for knee pain other than NSAIDs may be used as each patient's doctor thinks appropriate.
Participants are sent postal questionnaires three, six, 12 and 24 months after randomisation. One year and two years after randomisation participants are asked to visit the practice to have their blood pressure and respiratory function measured and blood taken for full blood count, serum ferritin, creatinine and liver function tests. The medical records are examined one year after randomisation to identify unplanned hospital admissions, and after two years (or at the end of the study) to collect health service activity data and confirm reported changes in medication and adverse effects. |
| Primary outcome measure(s) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, which measures pain and disability in the preceding 48 hours. |
| Secondary outcome measure(s) |
1. The postal version of the Chronic Pain Grade, which measures pain and disability over the preceding six months
2. The Euro Quality of Life questionnaire (EQ-5D), a measure of health-related quality of life 3. The 36-item Short Form health survey (SF-36) version 2, a different measure of health related quality of life 4. A question assessing satisfaction with treatment |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications |
2008 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/18511476
2008 HTA monograph at http://www.ncbi.nlm.nih.gov/pubmed/18505668 2008 main results publication at http://www.ncbi.nlm.nih.gov/pubmed/18056743 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16274477 |
| Contact name | Prof Martin Underwood |
| Address |
Queen Mary's School of Medicine & Dentistry
Barts & The London Centre for Health Sciences Abernethy Building 2 Newark Street Whitechapel |
| City/town | London |
| Zip/Postcode | E1 2AT |
| Country | United Kingdom |
| Tel | +44 (0)207 882 2511 |
| Fax | +44 (0)207 882 2552 |
| m.underwood@qmul.ac.uk | |
| Sponsor | Department of Health (UK) |
| Address |
Quarry House
Quarry Hill |
| City/town | Leeds |
| Zip/Postcode | LS2 7UE |
| Country | United Kingdom |
| Sheila.Greener@doh.gsi.gov.uk | |
| Sponsor website: | http://www.dh.gov.uk/en/index.htm |
| Date applied | 25/04/2003 |
| Last edited | 24/08/2009 |
| Date ISRCTN assigned | 25/04/2003 |
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