Arthritis, Osteo Arthritis of the Knee
Conditions
Keywords
high-frequency continuous ultrasound, sustained acoustic medicine, low-intensity continuous ultrasound, wearable long duration ultrasound
Brief summary
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.
Detailed description
This is an 12-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 12 weeks, patients will self-apply their assigned treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as at the completion of treatment. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.
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\^2 with 2.5% Diclofenac patches.
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
DRUGIntra articular injection
Single intraarticular injection of 1cc 40mg/cc triamcinolone acetonide
Sponsors
ZetrOZ, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Report that knee 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 ultrasound gel 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 use of opioid and/or non-opioid analgesic medications. * Be willing to discontinue any other interventional treatment modalities on the knee 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. * Is non-ambulatory (unable to walk). * 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 replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months. * Are currently taking steroids. * Have any contraindication to radiograph. * Have a secondary cause of arthritis (metabolic or inflammatory). * Have a known contraindication, allergy, or hypersensitivity to corticosteroids or any component of Kenalog®-40 (if assigned to the injection group).
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 12 weeks | Change in the self-described pain units on a scale by patient at baseline and post-treatment |
| Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Through study completion, average of 12 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 12 weeks. | Subject-reported rating of impact of pain on sleep on a scale from 0 no impact, to 100 greatest impact. |
Countries
United States
Contacts
CONTACTRalph Ortiz, DO, MPH
Outcome results
None listed