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

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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.

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.

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

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ZetrOZ Wearable Ultrasound Clinical Study
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



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

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)

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): NCT02083861


Locations
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United States, New York
Medical Pain Consultants
Dryden, New York, United States, 13053
Sponsors and Collaborators
ZetrOZ, Inc.
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Ralph Ortiz, D.O., MPH Medical Pain Consultants
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ZetrOZ, Inc.
ClinicalTrials.gov Identifier: NCT02083861    
Other Study ID Numbers: OA-03
1R43MD008597-01 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2014    Key Record Dates
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018
Last Verified: April 2018
Keywords provided by ZetrOZ, Inc.:
osteoarthritis
arthritis
musculoskeletal
connective tissue disease
ultrasound
pain
mobility
heat
strength
ZetrOZ
LITUS
Sam
grade 1
grade 2
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxymetazoline
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents