Antonio Frizziero1, Araldo Causero2, Stefano Bernasconi3, Rocco Papalia4, Mario Longo5, Vincenzo Sessa6, Francesco Sadile7, Pasquale Greco8, Umberto Tarantino9, Stefano Masiero1, Stefano Rovati10, Valeria Frangione10. 1. Department of Physical and Rehabilitation Medicine, University of Padova, Padova, Italy. 2. Orthopaedics Clinic, "Santa Maria Misericordia" University Hospital, Udine, Italy. 3. Orthopaedics and Traumatology Unit, General Hospital, Legnano (MI), Italy. 4. Orthopaedics and Traumatology Unit, Campus Bio-Medico University, Rome, Italy. 5. Orthopaedics and Traumatology Unit, General Hospital, Pavullo nel Frignano (MO), Italy. 6. Orthopaedics and Traumatology Unit, "San Giovanni Calibita Fatebenefratelli" Hospital, Rome, Italy. 7. Department of Orthopaedic Surgery, University Federico II, Naples, Italy. 8. Orthopaedics and Traumatology Unit, "Sant'Anna e San Sebastiano" Hospital, Caserta, Italy. 9. Orthopaedics and Traumatology Department, "Tor Vergata" University Hospital, Rome, Italy. 10. IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.
Abstract
OBJECTIVE: to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy. METHODS: randomized, double-blind, placebo-controlled study with assignment 2:2:1:1 to BMV medicated plaster applied daily for 12 hours, daily for 24 hours or matched placebo. 62 patients aged ≥18 years with chronic lateral elbow tendinopathy were randomized. The primary efficacy variable was pain reduction (VAS) at day 28. Secondary objectives included summed pain intensity differences (SPID), overall treatment efficacy and tolerability. RESULTS: mean reduction in VAS pain score at day 28 was greater in both BMV medicated plaster groups, -39.35±27.69 mm for BMV12-h and -36.91±32.50 mm for BMV24-h, than with placebo, -20.20±27.32 mm. Considering the adjusted mean decreases, there was a statistically significant difference between BMV12-h and placebo (p=0.0110). Global pain relief (SPID) and overall treatment efficacy were significantly better with BMV. BMV and placebo plasters had similar local tolerability and there were few treatment-related adverse events. CONCLUSIONS:BMV plaster was significantly more effective than placebo at reducing pain in patients with chronic elbow tendinopathies. The BMV plaster was safe and well tolerated.
RCT Entities:
OBJECTIVE: to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy. METHODS: randomized, double-blind, placebo-controlled study with assignment 2:2:1:1 to BMV medicated plaster applied daily for 12 hours, daily for 24 hours or matched placebo. 62 patients aged ≥18 years with chronic lateral elbow tendinopathy were randomized. The primary efficacy variable was pain reduction (VAS) at day 28. Secondary objectives included summed pain intensity differences (SPID), overall treatment efficacy and tolerability. RESULTS: mean reduction in VAS pain score at day 28 was greater in both BMV medicated plaster groups, -39.35±27.69 mm for BMV12-h and -36.91±32.50 mm for BMV24-h, than with placebo, -20.20±27.32 mm. Considering the adjusted mean decreases, there was a statistically significant difference between BMV12-h and placebo (p=0.0110). Global pain relief (SPID) and overall treatment efficacy were significantly better with BMV. BMV and placebo plasters had similar local tolerability and there were few treatment-related adverse events. CONCLUSIONS:BMV plaster was significantly more effective than placebo at reducing pain in patients with chronic elbow tendinopathies. The BMV plaster was safe and well tolerated.