Trial Outcomes & Findings for Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain (NCT NCT05050448)
NCT ID: NCT05050448
Last Updated: 2025-05-02
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/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-05-02
Participant Flow
Participant milestones
| Measure |
SAM Ultrasound Device and Diclofenac Patch
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
|
SAM2 Ultrasound Device and Diclofenac Patch
Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
|
Topical Pain-Relief Gel
Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.
1% Diclofenac Topical Gel: Topical pain-relief gel
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SAM Ultrasound Device and Diclofenac Patch
n=20 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
|
SAM2 Ultrasound Device and Diclofenac Patch
n=20 Participants
Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
|
Topical Pain-Relief Gel
n=20 Participants
Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.
1% Diclofenac Topical Gel: Topical pain-relief gel
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
60 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
30 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
30 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 8 weeksChange 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
| Measure |
SAM Ultrasound Device and Diclofenac Patch
n=17 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
|
SAM2 Ultrasound Device and Diclofenac Patch
n=17 Participants
Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
|
Topical Pain-Relief Gel
n=18 Participants
Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.
1% Diclofenac Topical Gel: Topical pain-relief gel
|
|---|---|---|---|
|
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
|
-3.56 units on a scale
Standard Error 0.37
|
-3.29 units on a scale
Standard Error 0.41
|
-1.00 units on a scale
Standard Error 0.37
|
PRIMARY outcome
Timeframe: 8 weeksWOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome.
Outcome measures
| Measure |
SAM Ultrasound Device and Diclofenac Patch
n=17 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
|
SAM2 Ultrasound Device and Diclofenac Patch
n=17 Participants
Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
|
Topical Pain-Relief Gel
n=18 Participants
Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.
1% Diclofenac Topical Gel: Topical pain-relief gel
|
|---|---|---|---|
|
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline
|
-15.71 units on a scale
Standard Error 2.31
|
-16.71 units on a scale
Standard Error 4.87
|
-5.72 units on a scale
Standard Error 2.31
|
Adverse Events
SAM Ultrasound Device and Diclofenac Patch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAM2 Ultrasound Device and Diclofenac Patch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topical Pain-Relief Gel
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