Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01993693|
Recruitment Status : Terminated
First Posted : November 25, 2013
Last Update Posted : November 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: Ultrasonic Diathermy Device Device: Sham Ultrasonic Diathermy Device||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Wearable Therapeutic Ultrasound Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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 Name: 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 Name: Sham
- Pain [ Time Frame: 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).
- Mobility [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993693
|United States, New York|
|East Syracuse, New York, United States, 13057|
|Principal Investigator:||Timothy A. Damron, MD||SUNY Upstate Orthopedics|