Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain

Knee Osteoarthritis Clinical Trial

Official title:

Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050448
• Other study ID #: HF-01-2021
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: ZetrOZ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Sustained Acoustic Device with 2.5% Diclofenac Patch
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.

Drug:
• 1% Diclofenac Topical Gel
Topical pain-relief gel

Locations

Country	Name	City	State
United States	Cayuga Medical Center - Medical Pain Consultants	Dryden	New York
United States	Orthopaedic Foundation	Stamford	Connecticut
United States	ZetrOZ Systems	Trumbull	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ZetrOZ, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-	Through study completion, average of 8 weeks
Primary	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).	Through study completion, average of 8 weeks

External Links

•   Class II Medical Device