Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis

Not Applicable

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Device: Ultrasonic Diathermy Device; Device: Sham Ultrasonic Diathermy Device

• Registration Number: NCT01993693
• Lead Sponsor: ZetrOZ, Inc.

Brief Summary

The purpose of this study is to evaluate the ability of a wearable therapeutic ultrasound device to reduce pain and increase mobility for subjects with knee osteoarthritis.

Detailed Description

Up to 50 million people in the U.S. suffer from some form of chronic pain, and 60% of these Americans are under 65 and have limited mobility because of knee or hip Osteoarthritis (OA). Pharmaceuticals currently dominate the treatment options due to widespread insurance coverage and convenience. However, there are a myriad of public health problems associated with analgesic use, including costs, untoward side effects, and addiction potential with opioid analgesics.

Ultrasound therapy for pain and healing has been approved by the U.S. FDA and has been in use around the globe for the last 60 years. Traditionally, ultrasound-mediated pain treatment has been delivered in clinics and has been limited to short and confined periods of 5-15 min at acoustic intensities from 1-4 W/cm2 over a course of weeks to months. Over the past decade, research has increasingly focused on lower-intensity therapeutic ultrasound (30-1000 mW/cm2) delivered over extended 1-8 hr periods. (mW = milliwatt) Recent animal studies using low-intensity therapeutic ultrasound (LITUS) have demonstrated successful inflammation reduction, reduced cartilage degeneration, and tendon and fracture healing. It is believed that using a lower-intensity ultrasonic treatment regimen over extended treatment periods works with the body's natural healing process and minimizes acoustic insult as compared with traditional, higher intensity treatments. This study proposes to evaluate clinically the first wearable low intensity ultrasound system for noninvasive treatment of arthritis pain. This technology has the potential to measurably increase the quality of life for millions of people who suffer from osteoarthritis pain by providing a safe, effective, and easy-to-use treatment.

The pilot study will test the versatile ultrasound therapy system in a clinical study that will enroll up to 60 patients with mobility-impairing knee OA. The goal of the study is to establish statistically significant data that daily 4 hour LITUS treatment decreases participant pain (Visual Analog Scale \[VAS\]) and improves patient mobility (measured by an accelerometer worn by each participant) over placebo devices.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Status Verified: 2014-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonic Diathermy Device	Ultrasonic Diathermy Device	Therapeutic ultrasound used daily.
Sham Ultrasonic Diathermy Device	Sham Ultrasonic Diathermy Device	Sham device that does not deliver ultrasound

Primary Outcome Measures

Name	Time	Method
Pain	Pain will be recorded twice a day, immediately before application of the device and then immediately after the 4 hour treatment.	Pain will be recorded using the Visual Analogue Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Mobility	Mobility will be recorded logged every 5 minutes, up to 24 hours a day, by the actigraph that the subject is wearing on their wrist.	Mobility will be measured using an actigraph that will be worn on the subject's wrist 24 hours a day.

Trial Locations

Locations (1)

Upstate Orthopedics; 🇺🇸 East Syracuse, New York, United States