CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Intense Therapeutic Ultrasound Treatmentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03255733
NCT03255733N/ACompleted

Intense Therapeutic Ultrasound for Chronic, Subcutaneous Lateral Epicondylitis Musculoskeletal Pain Reduction

Guided Therapy Systems·interventional·Posted Aug 21, 2017·Updated Nov 17, 2017

In Brief

A clinical study evaluating Intense Therapeutic Ultrasound Treatment for Tennis Elbow. Completed, enrolled 29 participants across 1 site.

Detailed Summary

This study evaluates the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal tissue pain reduction began in July 2015 and was completed in March 2017. The More Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTennis Elbow
CountriesUnited States
CollaboratorsMore Foundation

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 21, 2017
Enrollment StartJul 14, 2015
Primary CompletionMar 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.9 years ago

Interventions

Intense Therapeutic Ultrasound Treatmentdevice