Osteoarthritis
Conditions
Keywords
Continuous ultrasound, Sustained Acoustic Medicine, Musculoskeletal Injuries, Low Intensity Continuous Ultrasound, Pain, Joint Injury, Osteoarthritis
Brief summary
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.
Interventions
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 worn for 4 hours at least 5 days a week via SAM patch.
Sponsors
ZetrOZ, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Report that knee, shoulder, elbow, ankle, hip, or spine pain negatively affects quality of life * Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study * Are deemed appropriate by their physician or by the study site physician to participate. * Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device. * Not use or initiate opioid and/or non-opioid analgesic medications. * Be willing to discontinue any other interventional treatment modalities on the treatment area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
Exclusion criteria
* 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. * Is a prisoner. * Has a pacemaker. * Has a malignancy in the treatment area. * Has an active infection, open sores, or wounds in the treatment area. * Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia. * Has a known neuropathy (disease of the brain or spinal nerves). * Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage). * Have knee, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months. * Requires oxygen support * Has an allergy to aspirin or other NSAIDs * Have a secondary cause of arthritis (metabolic or inflammatory)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline | Through study completion, average of 8 weeks | Change in the self described pain units on a scale by patient at baseline and post- |
| Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Time Frame: Through study completion, average of 8 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Rating of Change (GROC) on a Scale (-7 to +7) | Through study completion, average of 24 weeks. | Subject-reported change in overall pain on a scale, -7 = worst, +7 = best. |
| Change in the Pain & Sleep Questionnaire (PSQ-3) | Through study completion, average of 24 weeks. | Subject-reported rating of impact of pain on sleep on a scale from 0 no impact, to 100 greatest impact |
| Change in Depression Anxiety Stress Scale (DASS21) | Through study completion, average of 24 weeks. | 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. |
Countries
United States
Contacts
Primary ContactGeorge K. Lewis, Ph.D.
Outcome results
None listed