Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-16 @ 3:30 PM
Study NCT ID:
NCT02371902
Status:
COMPLETED
Last Update Posted:
2015-02-26
First Post:
2015-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study
Sponsor:
University of Roma La Sapienza
Organization:
Study Overview
Official Title:
Extracorporeal Shock Wave Therapy vs Cryoultrasound Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: