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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
Sponsor:
Collaborator:
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Ultrasonic Diathermy Device Device: Sham Ultrasonic Diathermy Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Wearable Therapeutic Ultrasound Study
Study Start Date : October 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Locations
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United States, New York
Upstate Orthopedics
East Syracuse, New York, United States, 13057
Sponsors and Collaborators
ZetrOZ, Inc.
State University of New York - Upstate Medical University
Investigators
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Principal Investigator: Timothy A. Damron, MD SUNY Upstate Orthopedics
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Responsible Party: ZetrOZ, Inc.
ClinicalTrials.gov Identifier: NCT01993693    
Other Study ID Numbers: OA-02
2012-1 ( Other Identifier: SUNY Upstate IRB (Upstate Medical University) )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: June 2014
Keywords provided by ZetrOZ, Inc.:
knee
pain
osteoarthritis
ultrasound
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases