Clinical trial NCT05050448: Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain
Official title: Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Keywords: Non-Steroidal Anti-Inflammatory Drugs
Sustained Acoustic Medication
Low-Intensity Continuous Ultrasound
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
* Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
* 35-80 years of age
* Report a frequent pain score between 4-7 (NRS range: 0-10) during the week preceding enrollment
* Report that knee pain negatively affects quality of life
* 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
* Deemed appropriate by their physician or by the study site physician to participate
* 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 initiate use of opioid and/or non-opioid analgesic medications
* Willing to discontinue any other interventional treatment modalities on the knee during the study period

Exclusion Criteria:

* Cannot successfully demonstrate the ability to put on and take off the device
* Display 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
* Have severe OA or have little to no cartilage in the knee
* Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
* Is non-ambulatory (unable to walk)
* 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 known neuropathy
* Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage)
* Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
* Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
* Currently taking steroids
* Have contraindication to radiograph
* Have a secondary cause of arthritis (metabolic or inflammatory)

Primary outcomes:
measure: Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
timeFrame: 8 weeks
measure: Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Orthopaedic Foundation
state: Connecticut
city: Trumbull
country: United States
facility: ZetrOZ Systems
state: Connecticut
city: Dryden
country: United States
facility: Cayuga Medical Center - Medical Pain Consultants
state: New York
Study officials:
affiliation: ZetrOZ Systems
name: George K Lewis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: