Trial Outcomes & Findings for Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial (NCT NCT02083861)
NCT ID: NCT02083861
Last Updated: 2018-05-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2018-05-07
Participant Flow
Participant milestones
| Measure |
Active Ultrasound Device
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.
|
Placebo Ultrasound Device
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 Study
STARTED
|
57
|
36
|
|
Overall Study
Treated
|
55
|
35
|
|
Overall Study
COMPLETED
|
51
|
33
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only patients that completed study included.
Baseline characteristics by cohort
| Measure |
Active Ultrasound Device
n=55 Participants
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.
|
Placebo Ultrasound Device
n=35 Participants
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
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 Years
n=51 Participants • Only patients that completed study included.
|
51.1 Years
n=33 Participants • Only patients that completed study included.
|
52.6 Years
n=84 Participants • Only patients that completed study included.
|
|
Sex: Female, Male
Female
|
28 Participants
n=51 Participants • Only patients that completed study included.
|
17 Participants
n=33 Participants • Only patients that completed study included.
|
45 Participants
n=84 Participants • Only patients that completed study included.
|
|
Sex: Female, Male
Male
|
23 Participants
n=51 Participants • Only patients that completed study included.
|
16 Participants
n=33 Participants • Only patients that completed study included.
|
39 Participants
n=84 Participants • Only patients that completed study included.
|
|
BMI
|
34.9 kg/m2
STANDARD_DEVIATION 8.9 • n=51 Participants • Only patients that completed study included.
|
34.5 kg/m2
STANDARD_DEVIATION 8.3 • n=33 Participants • Only patients that completed study included.
|
34.7 kg/m2
STANDARD_DEVIATION 8.6 • n=84 Participants • Only patients that completed study included.
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Patients that completed the entire study were included in analysis.
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.
Outcome measures
| Measure |
Active Ultrasound Device
n=51 Participants
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.
|
Placebo Ultrasound Device
n=33 Participants
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.
|
|---|---|---|
|
Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion
|
-1.96 units on a scale
Interval -2.92 to -1.0
|
-0.85 units on a scale
Interval -1.96 to 0.26
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SECONDARY outcome
Timeframe: Baseline, Week 6Population: Patients that completed the entire study were included in analysis.
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).
Outcome measures
| Measure |
Active Ultrasound Device
n=51 Participants
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.
|
Placebo Ultrasound Device
n=33 Participants
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.
|
|---|---|---|
|
Quality of Life (WOMAC) Change From Baseline
WOMAC Pain Score Change
|
-107.3 units on a scale
Interval -147.6 to -66.8
|
-60.8 units on a scale
Interval -100.3 to -21.2
|
|
Quality of Life (WOMAC) Change From Baseline
WOMAC Stiffness Score Change
|
-45.0 units on a scale
Interval -61.1 to -28.9
|
-17.1 units on a scale
Interval -36.0 to -1.9
|
|
Quality of Life (WOMAC) Change From Baseline
WOMAC Function Score Change
|
-352.3 units on a scale
Interval -480.7 to -224.0
|
-220.1 units on a scale
Interval -334.3 to -105.9
|
|
Quality of Life (WOMAC) Change From Baseline
WOMAC Total Score Change
|
-504.6 units on a scale
Interval -683.4 to -325.7
|
-311.2 units on a scale
Interval -473.4 to -148.9
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: 17 patient subset was assessed for range of motion pilot data.
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.
Outcome measures
| Measure |
Active Ultrasound Device
n=9 Participants
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.
|
Placebo Ultrasound Device
n=8 Participants
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.
|
|---|---|---|
|
Range of Motion Change From Baseline in Treated Knee
Flexion Change
|
-6.38 Degrees
Interval -40.5 to 27.8
|
-2.22 Degrees
Interval -29.1 to 24.6
|
|
Range of Motion Change From Baseline in Treated Knee
Extension Change
|
-17.75 Degrees
Interval -52.5 to 17.0
|
-5.56 Degrees
Interval -33.2 to 22.1
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksPopulation: 17 patient subset was assessed for muscle strength pilot data.
Muscle strength in flexion, extension, and rotation were measured using JTECH muscle testing equipment.
Outcome measures
| Measure |
Active Ultrasound Device
n=9 Participants
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.
|
Placebo Ultrasound Device
n=8 Participants
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.
|
|---|---|---|
|
Muscle Strength Change From Baseline in Treated Knee
Flexion
|
1.34 Newtons
Interval -2.22 to 4.89
|
1.01 Newtons
Interval -4.06 to 6.08
|
|
Muscle Strength Change From Baseline in Treated Knee
Rotation
|
3.21 Newtons
Interval 0.23 to 6.06
|
0.68 Newtons
Interval -3.89 to 5.25
|
|
Muscle Strength Change From Baseline in Treated Knee
Extension
|
1.91 Newtons
Interval -3.03 to 6.85
|
1.60 Newtons
Interval -2.74 to 5.94
|
Adverse Events
Active Ultrasound Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Ultrasound Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place