Minor soft tissue injuries, such as ankle or knee joint sprains, muscle strains or contusions Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Patients were randomised to receive either
1. DHEP medicated plaster (Flector®
, IBSA Institut Biochimique SA): twice daily (morning and evening, every 12 hours) for 7 days
2. Placebo plaster: twice daily (morning and evening, every 12 hours) for 7 days
Sponsors
Institut Biochimique SA (IBSA) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients and emergency patients of both gender 2. Aged between 18 and 65 years 3. With a minor soft tissue injury occurred within the past 72 hours 4. With pain on movement greater than or equal to 50 mm on VAS
Exclusion criteria
Exclusion criteria: 1. Severe injuries requiring orthopaedic, surgical or physiotherapeutic treatment 2. Open skin lesion or any dermatological condition at treated site 3. Administration of any topical medication within the past 24 hours 4. Administration of OTC analgesic or NSAIDs within the past 36-48 hours 5. Administration of long-acting NSAIDs within the past 72 hours 6. Administration of narcotic analgesics within the past 7 days 7. Administration of systemic anti-inflammatory steroidal drugs within the past 60 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in pain on movement (VAS score) at the end of treatment (Day 7), as com-pared to pre-treatment scores | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain on movement day-by-day evaluation (VAS score) 2. Summed pain intensity difference (SPID) 3. Rescue medication consumption (paracetamol) 4. Overall treatment efficacy as judged by patient and Investigator 5. Compliance to treatment 6. Overall treatment tolerability as judged by patient and Investigator 7. Adverse events 8. Pre-/post-treatment changes in haematology, blood chemistry, urinalysis or ECG tests | — |
Countries
China
Outcome results
None listed