Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial

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: NCT02083861
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
ZetrOZ, Inc.

Tracking Information
First Submitted Date  ICMJE March 7, 2014
First Posted Date  ICMJE March 11, 2014
Results First Submitted Date  ICMJE February 27, 2017
Results First Posted Date  ICMJE May 7, 2018
Last Update Posted Date May 7, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion [ Time Frame: Baseline, Week 6 ]
The numeric rating scale (NRS) was used to assess change in pain from baseline to study conclusion. NRS range from 0-10 with 0 being no pain and 10 the worst pain possible.
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
  • Change in pain on the visual analog scale (VAS) from baseline to study conclusion [ Time Frame: Baseline, Week 8 ]
  • Change in pain score (VAS) from the previous day [ Time Frame: Daily: Day 0, Day 1...Day 56 ]
  • Change in mobility from baseline to study conclusion [ Time Frame: Baseline, Week 8 ]
    Patients wear an actigraph (a wearable accelerometer clinically proven to capture high resolution movement data and physical activity measures) throughout all waking hours of the study. (www.actigraphcorp.com)
  • Change in mobility from previous day [ Time Frame: Daily: Day 0, Day 1...Day 56 ]
    Patients wear an actigraph (a wearable accelerometer clinically proven to capture high resolution movement data and physical activity measures) throughout all waking hours of the study. (www.actigraphcorp.com)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • Quality of Life (WOMAC) Change From Baseline [ Time Frame: Baseline, Week 6 ]
    WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index). WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400).
  • Range of Motion Change From Baseline in Treated Knee [ Time Frame: Baseline, Week 6 ]
    JTech equipment was used to evaluate range of motion range of motion using an inclinometer (www.jtechmedical.com) in flexion and extension of the treated knee. 0 degrees is fully extended and 150 degrees is normal flexion. Positive flexion change indicates improvement in flexion. Negative extension indicates improvement in extension.
  • Muscle Strength Change From Baseline in Treated Knee [ Time Frame: Baseline to 6 Weeks ]
    Muscle strength in flexion, extension, and rotation were measured using JTECH muscle testing equipment.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
  • Change in quality of life from baseline [ Time Frame: Baseline, Week 8 ]
    WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index)
  • Change in range of motion and muscle strength of affected knee vs. unaffected knee [ Time Frame: Baseline, Week 8 ]
    JTech equipment will be leveraged to evaluate muscle strength and range of motion using a dynamometer and inclinometer (www.jtechmedical.com)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 10, 2014)
Number of participants with Serious and Non-Serious Adverse Events [ Time Frame: Baseline through Week 8 (duration of study) ]
 
Descriptive Information
Brief Title  ICMJE Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial
Official Title  ICMJE ZetrOZ Wearable Ultrasound Clinical Study
Brief Summary The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase range of motion and muscle strength of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.
Detailed Description

This is an eight week study to clinically evaluate the effect of the low intensity long duration ultrasound (LITUS) device on symptoms of patients suffering from knee osteoarthritis. The device, sam® has been FDA-cleared for use. For the first two weeks of the study, baseline data will be collected as patients report pain scores (NRS) three times per day. During the following 6 weeks, patients will self-apply the wearable LITUS device to their affected knee for 4 hours daily. Each day of the study, pain scores (NRS) will be recorded immediately before application of LITUS device as well as 30 minutes, 2-hours and 4-hours after applying the device. A quality of life assessment (WOMAC), muscle strength and range of motion assessment (JTech) will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.

Up to 93 subjects will be recruited from neighboring communities to the study site. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals where non-pharmacotherapies do not exist to manage pain. Subjects will be randomly assigned to active (60%) and placebo groups (40%). The sponsor and investigators are blinded as to which type of device each patient is assigned.

The study will be monitored by an external monitor and a data safety monitoring board (DSMB).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Device: Sam Ultrasonic Diathermy Device
Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
Other Names:
  • ZetrOZ ultrasound device
  • wearable ultrasound device
  • long duration ultrasound
  • LITUS device
  • long duration low intensity device
Study Arms  ICMJE
  • Experimental: Active ultrasound device
    Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
    Intervention: Device: Sam Ultrasonic Diathermy Device
  • Placebo Comparator: Placebo ultrasound device
    Patients wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
    Intervention: Device: Sam Ultrasonic Diathermy Device
Publications * Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018 Oct 16;13(1):257. doi: 10.1186/s13018-018-0965-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2017)
93
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2014)
80
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Physician-diagnosed mild to moderate knee osteoarthritis (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
  • Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
  • 35-80 years of age
  • Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding enrollment
  • Report that knee pain negatively affects quality of life
  • 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
  • Deemed appropriate by their physician or by the study site physician to participate

Exclusion Criteria:

  • Cannot successfully demonstrate the ability to put on and take off the device
  • Display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions.
  • Have severe OA or have little to no cartilage in the knee
  • Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
  • Are non-ambulatory
  • Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
  • Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
  • Currently taking steroids
  • Have contraindication to radiograph
  • Have a secondary cause of arthritis (metabolic or inflammatory)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083861
Other Study ID Numbers  ICMJE OA-03
1R43MD008597-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZetrOZ, Inc.
Study Sponsor  ICMJE ZetrOZ, Inc.
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Ralph Ortiz, D.O., MPH Medical Pain Consultants
PRS Account ZetrOZ, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP