Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-85
SponsorZetrOZ, Inc.
About this trial
The purpose of this study is to assess the ability of long-duration high-frequency continuous-wave therapeutic ultrasound to alleviate knee Osteoarthritis pain over an 12-week period. The primary objective of this study is to evaluate the analgesic effect of ultrasound treatment in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of ultrasound treatment to improve joint function.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
Are between 65-85 years of age
Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
Disqualifiers
Cannot successfully demonstrate the ability to put on and take off the device.
Displays 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.
Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
Is pregnant.
Trial design
Design model
Parallel
Treatments tested in this trial
Sustained Acoustic Device with 2.5% Diclofenac Patch
DevicePatients 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\^2 with 2.5% Diclofenac patches.
Sustained Acoustic Device with 0% Diclofenac Patch
DevicePatients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
Intra articular injection
DrugSingle intraarticular injection of 1cc 40mg/cc triamcinolone acetonide
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: SAM Ultrasound Device and Diclofenac PatchExperimental treatment 1 intervention
Group B: SAM Ultrasound Device and SAM PatchActive comparator 1 intervention
Group C: Corticosteroid InjectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Change in the self-described pain units on a scale by patient at baseline and post-treatment
Time frame
Through study completion, average of 12 weeks2
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).
Time frame
Through study completion, average of 12 weeks.Secondary outcomes
1
Change in Global Rating of Change (GROC) on a Scale (-7 to +7)
Subject-reported rating of impact of pain on sleep on a scale from 0 no impact, to 100 greatest impact.
Time frame
Through study completion, average of 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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