The study design for comparing ketoprofen patches and diclofenac gel was a prospective, randomized, open-label trial conducted over 7-14 days. It involved outpatients aged 18-70 with acute, sport-related soft-tissue injuries (sprains, strains, contusions) occurring within the prior 48 hours. Participants were randomly assigned to either a once-daily 100 mg ketoprofen patch or a diclofenac gel applied 2-4 g three times daily. The primary objective was to compare efficacy in pain reduction, functional improvement, and treatment compliance. Results showed comparable pain relief (79% vs. 77% reduction at day 7), with the ketoprofen patch demonstrating superior functional recovery and higher cure rates (64% vs. 46%).
Key Points Explained:
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Study Type & Duration
- Prospective, randomized, open-label design: Eliminated selection bias through randomization while allowing real-world assessment of treatment effects.
- 7-14 day timeframe: Captured both short-term pain relief (day 7) and longer-term functional recovery (day 14).
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Participant Profile
- Age 18-70: Focused on the active demographic most likely to experience sports injuries.
- Acute soft-tissue injuries: Included sprains, strains, and contusions diagnosed within 48 hours to standardize baseline pain levels.
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Intervention Groups
- Ketoprofen patches[/topic/ketoprofen-patches]: 100 mg applied once daily, emphasizing convenience and sustained release.
- Diclofenac gel: 2-4 g applied thrice daily, representing a standard topical NSAID regimen.
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Outcome Measures
- Pain reduction: Both treatments achieved >75% pain reduction by day 7, with ketoprofen showing marginally better efficacy (-1.17 difference, 95% CI -5.86 to 3.52).
- Functional improvement: Ketoprofen outperformed in restoring mobility (e.g., pain on passive motion at days 7/14) and pressure tolerance.
- Cure rates: Higher with ketoprofen (64% vs. 46%), likely due to consistent drug delivery from the patch.
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Practical Implications
- Compliance advantage: Once-daily patches may improve adherence over multi-dose gels.
- Tolerability: Both treatments had low adverse events, but ketoprofen scored higher in patient-reported comfort.
Did the study’s open-label design influence patient-reported outcomes? While blinding reduces bias, the focus on real-world usability justified this approach for comparing adherence and comfort. The results highlight how delivery systems—not just active ingredients—shape therapeutic success in sports medicine.
Summary Table:
| Aspect | Ketoprofen Patch | Diclofenac Gel |
|---|---|---|
| Dosage Frequency | Once daily (100 mg) | Thrice daily (2-4 g) |
| Pain Reduction (Day 7) | 79% | 77% |
| Functional Recovery | Superior | Moderate |
| Cure Rate | 64% | 46% |
| Compliance | High (once daily) | Moderate (thrice daily) |
| Patient Comfort | Higher | Lower |
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