Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis

NCT ID: NCT01993693

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-07-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ultrasonic Diathermy Device

Therapeutic ultrasound used daily.

Group Type: EXPERIMENTAL

Ultrasonic Diathermy Device

Intervention Type: 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.

Sham Ultrasonic Diathermy Device

Sham device that does not deliver ultrasound

Group Type: PLACEBO_COMPARATOR

Sham Ultrasonic Diathermy Device

Intervention Type: DEVICE

Sham therapy delivered by Ultrasonic Diathermy Device that appears identical to active device but does not deliver ultrasound

Interventions

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.

Intervention Type: DEVICE

Sham Ultrasonic Diathermy Device

Sham therapy delivered by Ultrasonic Diathermy Device that appears identical to active device but does not deliver ultrasound

Intervention Type: DEVICE

Other Intervention Names

sam; Sham

Eligibility Criteria

Exclusion Criteria

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).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: collaborator

ZetrOZ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy A. Damron, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Upstate Orthopedics

Locations

Upstate Orthopedics

East Syracuse, New York, United States

Countries

United States

Other Identifiers

2012-1

Identifier Type: OTHER

Identifier Source: secondary_id

OA-02

Identifier Type: -

Identifier Source: org_study_id