Topical or Oral Ibuprofe
- Conditions
- Knee painMusculoskeletal Diseases
- Registration Number
- ISRCTN79353052
- Lead Sponsor
- Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 283
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, which measures pain and disability in the preceding 48 hours.
- Secondary Outcome Measures
Name Time Method 1. The postal version of the Chronic Pain Grade, which measures pain and disability over the preceding six months<br>2. The Euro Quality of Life questionnaire (EQ-5D), a measure of health-related quality of life<br>3. The 36-item Short Form health survey (SF-36) version 2, a different measure of health related quality of life<br>4. A question assessing satisfaction with treatment