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Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial

NCT02083861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2018-05-07

Study results available
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Summary

The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase range of motion and muscle strength of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.

Conditions

Interventions

DEVICE

Sam Ultrasonic Diathermy Device

Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • ZetrOZ, Inc.

    lead INDUSTRY

Principal Investigators

  • Ralph Ortiz, D.O., MPH · Medical Pain Consultants

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02083861 on ClinicalTrials.gov