Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis

Wearable Therapeutic Ultrasound Study

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.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Ultrasonic Diathermy Device; Device: Sham Ultrasonic Diathermy Device

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • East Syracuse, New York, United States, 13057
      • Upstate Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Individual will be included if they:

1. Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months,
2. are between 35-65 years of age
3. report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
4. report mobility limitations because of their knee pain
5. are currently not taking any prescription pain medication other than nonsteroidal antiinflammatory drugs (NSAIDs). All pain medication taken during the study should be documented.
6. are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
7. are deemed appropriate by their physician to participate.

Individuals will be excluded if they:

1. cannot successfully demonstrate the ability to put on and take off the device
2. are cognitively impaired
3. have bone-on-bone crepitus
4. have severe OA or patients with little to no cartilage on the knee
5. have knee replacement or other surgical intervention
6. take variable prescription medication
7. are non-ambulatory
8. participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
9. are currently taking neuropathic medications (ie: Neurontin, Lyrica or Topamax) and/or antidepressants (ie: Amitriptyline).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasonic Diathermy Device; Therapeutic ultrasound used daily.	Device: Ultrasonic Diathermy Device; The Ultrasonic Diathermy Device provides low intensity therapeutic ultrasound to musculoskeletal tissues and joints for the purpose of pain relief, relief of muscle spasm, treatment of joint contraction, and local increase of circulation. The device is FDA-cleared for up to 4 hours of continuous use per treatment. It is a stationary hands-free device.; Other Names: sam
Placebo Comparator: Sham Ultrasonic Diathermy Device; Sham device that does not deliver ultrasound	Device: Sham Ultrasonic Diathermy Device; Sham therapy delivered by Ultrasonic Diathermy Device that appears identical to active device but does not deliver ultrasound; Other Names: Sham

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility	Mobility will be measured using an actigraph that will be worn on the subject's wrist 24 hours a day.	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.

Collaborators and Investigators

• Sponsor: ZetrOZ, Inc.
• Collaborators: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Timothy A. Damron, MD, SUNY Upstate Orthopedics

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: osteoarthritis; pain; ultrasound; knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OA-02; 2012-1 (SUNY Upstate IRB (Upstate Medical University))