Trial Outcomes & Findings for Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis (NCT NCT04391842)

Last Updated: 2023-06-27

Results Overview

Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

34 participants

Primary outcome timeframe

7 days

Results posted on

2023-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: SAM Ultrasound and Diclofenac Patch Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. Sustained Acoustic Device with 1% Diclofenac patch: 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 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: SAM Ultrasound and Diclofenac Patch Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. Sustained Acoustic Device with 1% Diclofenac patch: 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 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: SAM Ultrasound and Diclofenac Patch n=32 Participants Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. Sustained Acoustic Device with 1% Diclofenac patch: 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 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device
Age, Categorical <=18 years	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=32 Participants
Age, Categorical >=65 years	17 Participants n=32 Participants
Age, Continuous	53.6 YEARS STANDARD_DEVIATION 8.8 • n=32 Participants
Sex: Female, Male Female	14 Participants n=32 Participants
Sex: Female, Male Male	18 Participants n=32 Participants
Region of Enrollment United States	32 participants n=32 Participants
Numeric Rating Scale (NRS)	4.06 Pain Units on a Scale STANDARD_DEVIATION 2.39 • n=32 Participants
WOMAC	1168 Units on a Scale STANDARD_DEVIATION 528 • n=32 Participants

PRIMARY outcome

Timeframe: 7 days

Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.

Outcome measures

Outcome measures
Measure	Experimental: SAM Ultrasound and Diclofenac Patch n=32 Participants Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. Sustained Acoustic Device with 1% Diclofenac patch: 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 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline	2.00 pain units on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: 7 days

WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in the scores. 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

Outcome measures
Measure	Experimental: SAM Ultrasound and Diclofenac Patch n=32 Participants Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. Sustained Acoustic Device with 1% Diclofenac patch: 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 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores, Ranging From 0 Being No Difficulty to 2400 Being Extreme Difficulty, From Baseline	-353 scores on a scale Interval -508.0 to -195.0

Adverse Events

Experimental: SAM Ultrasound and Diclofenac Patch

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

Dr. Ralph Ortiz

Medical Pain Consultants

Phone: (607) 844-9979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place