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Topical or Oral Ibuprofen

Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain in older people?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79353052
Enrollment
283
Registered
2003-04-25
Start date
2002-07-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Knee pain Musculoskeletal Diseases

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 chose

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, which measures pain and disability in the preceding 48 hours.

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026