NCT02371902

ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study

Extracorporeal Shock Wave Therapy vs Cryoultrasound Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Chronic lateral epicondylitis is usually managed conservatively. The purpose of this single-blinded, randomized, controlled study is to compare the clinical therapeutic effects of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US) therapy in chronic lateral epicondylitis (LE) during a period of 12 months.

Detailed description

Eighty participants with chronic LE were randomly assigned to receive 3 ESWT sessions at 48/72-hours intervals -2400 impulses at energy flux density 0.14-0.20 mJ/mm2 at each session- (ESWT Group, n=40) or 12 Cryo-US therapy sessions (4 daily sessions per week) in a continuous modality at 1.8 Watt/cm2 and -2˚C at each session- (Cryo-US Group, n=40). Visual Analogue Scale (VAS) and satisfactory results, considered as the sum of the excellent and good scores in the Roles and Maudsley score, were used as outcome measures at baseline and 3, 6, and 12 months post-treatment.

Conditions

• Tendinopathy

Interventions

Type	Name	Description
DEVICE	MODULITH® SLK, STORZ MEDICAL AG, Switzerland	Three sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2, depending on the maximum tolerated pain of each patient. Analgesics or local anaesthetics were not administered before, during or after treatment.
DEVICE	Cryoultrasound™, Medisport S.r.l., Italy	Cryo-US therapy was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. The treatment was performed in 3 weeks (4 daily sessions per week).

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2015-02-26
• Last updated: 2015-02-26

Locations

1 site across 1 country: Italy