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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Knee Osteoarthritis
Intervention Device: Sam Ultrasonic Diathermy Device
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Ultrasound Device Placebo Ultrasound Device
Hide Arm/Group Description

Patients (n=55) 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.

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.

Patients (n=35) 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.

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.

Period Title: Overall Study
Started 57 36
Treated 55 35
Completed 51 33
Not Completed 6 3
Arm/Group Title Active Ultrasound Device Placebo Ultrasound Device Total
Hide Arm/Group Description

Patients (n=55) 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.

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.

Patients (n=35) 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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 55 35 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 51 participants 33 participants 84 participants
53.6
(35 to 80)
51.1
(35 to 72)
52.6
(35 to 80)
[1]
Measure Analysis Population Description: Only patients that completed study included.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 33 participants 84 participants
Female
28
  54.9%
17
  51.5%
45
  53.6%
Male
23
  45.1%
16
  48.5%
39
  46.4%
[1]
Measure Analysis Population Description: Only patients that completed study included.
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 51 participants 33 participants 84 participants
34.9  (8.9) 34.5  (8.3) 34.7  (8.6)
[1]
Measure Analysis Population Description: Only patients that completed study included.
1.Primary Outcome
Title Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the entire study were included in analysis.
Arm/Group Title Active Ultrasound Device Placebo Ultrasound Device
Hide Arm/Group Description:

Patients (n=55) 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.

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.

Patients (n=35) 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.

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.

Overall Number of Participants Analyzed 51 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.96
(-2.92 to -1.00)
-0.85
(-1.96 to 0.26)
2.Secondary Outcome
Title Quality of Life (WOMAC) Change From Baseline
Hide Description 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).
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the entire study were included in analysis.
Arm/Group Title Active Ultrasound Device Placebo Ultrasound Device
Hide Arm/Group Description:

Patients (n=55) 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.

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.

Patients (n=35) 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.

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.

Overall Number of Participants Analyzed 51 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
WOMAC Pain Score Change
-107.3
(-147.6 to -66.8)
-60.8
(-100.3 to -21.2)
WOMAC Stiffness Score Change
-45.0
(-61.1 to -28.9)
-17.1
(-36.0 to -1.9)
WOMAC Function Score Change
-352.3
(-480.7 to -224.0)
-220.1
(-334.3 to -105.9)
WOMAC Total Score Change
-504.6
(-683.4 to -325.7)
-311.2
(-473.4 to -148.9)
3.Secondary Outcome
Title Range of Motion Change From Baseline in Treated Knee
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
17 patient subset was assessed for range of motion pilot data.
Arm/Group Title Active Ultrasound Device Placebo Ultrasound Device
Hide Arm/Group Description:

Patients (n=9) 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.

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.

Patients (n=8) 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.

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.

Overall Number of Participants Analyzed 9 8
Mean (95% Confidence Interval)
Unit of Measure: Degrees
Flexion Change
-6.38
(-40.5 to 27.8)
-2.22
(-29.1 to 24.6)
Extension Change
-17.75
(-52.5 to 17.0)
-5.56
(-33.2 to 22.1)
4.Secondary Outcome
Title Muscle Strength Change From Baseline in Treated Knee
Hide Description Muscle strength in flexion, extension, and rotation were measured using JTECH muscle testing equipment.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
17 patient subset was assessed for muscle strength pilot data.
Arm/Group Title Active Ultrasound Device Placebo Ultrasound Device
Hide Arm/Group Description:

Patients (n=9) 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.

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.

Patients (n=8) 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.

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.

Overall Number of Participants Analyzed 9 8
Mean (95% Confidence Interval)
Unit of Measure: Newtons
Flexion
1.34
(-2.22 to 4.89)
1.01
(-4.06 to 6.08)
Rotation
3.21
(0.23 to 6.06)
0.68
(-3.89 to 5.25)
Extension
1.91
(-3.03 to 6.85)
1.60
(-2.74 to 5.94)
Time Frame 8 weeks (study duration)
Adverse Event Reporting Description No adverse events (serious or non-serious) were observed. Patients were supplied with daily diaries where adverse reactions could be self reported. Additionally, follow-up appointments assessed for adverse reactions during weeks 1, 3 (baseline) and week 5, 7, 8 (intervention period).
 
Arm/Group Title Active Ultrasound Device Placebo Ultrasound Device
Hide Arm/Group Description

Patients (n=55) 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.

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.

Patients (n=35) 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.

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.

All-Cause Mortality
Active Ultrasound Device Placebo Ultrasound Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/35 (0.00%) 
Hide Serious Adverse Events
Active Ultrasound Device Placebo Ultrasound Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Ultrasound Device Placebo Ultrasound Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/35 (0.00%) 
Small number of patients enrolled in range of motion and strength study may have limited statistical analysis. Future studies should include larger sample sizes.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ralph Ortiz
Organization: Pain Management Associates
Phone: (607) 844-9979
EMail: rodoc@cnymail.com
Layout table for additonal information
Responsible Party: ZetrOZ, Inc.
ClinicalTrials.gov Identifier: NCT02083861    
Other Study ID Numbers: OA-03
1R43MD008597-01 ( U.S. NIH Grant/Contract )
First Submitted: March 7, 2014
First Posted: March 11, 2014
Results First Submitted: February 27, 2017
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018