Sustained Acoustic Medicine for Osteoarthritis Pain
ConditionOsteoarthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age35-85
SponsorZetrOZ, Inc.
About this trial
The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).
Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
Are between 35-85 years of age
Report a frequent pain score between 3-7 (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
Single group
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@ with 2.5% Diclofenac patches.
2.5% Diclofenac Patches
DrugTopical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: SAM Ultrasound Device and Diclofenac PatchExperimental treatment 2 interventions
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-
Time frame
Through study completion, average of 8 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
Time Frame: Through study completion, average of 8 weeksSecondary outcomes
1
Change in Global Rating of Change (GROC) on a Scale (-7 to +7)
Subject-reported change in overall pain on a scale, -7 = worst, +7 = best.
Time frame
Through study completion, average of 24 weeks.2
Change in the Pain & Sleep Questionnaire (PSQ-3)
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 24 weeks.3
Change in Depression Anxiety Stress Scale (DASS21)
Subject-reported measures of depression, anxiety, and stress on a scale of 0-3, 0 being not applicable, 1 meaning applicable to some degree, 2 meaning applicable often, and 3 meaning applicable most of the time. Questions are divided into three categories: depression, anxiety, and stress.
Time frame
Through study completion, average of 24 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov