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

ZetrOZ

Status and phase: Completed; Phase 2; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Device: Sustained Acoustic Device with 2.5% Diclofenac Patch; Drug: 1% Diclofenac Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05050448

HF-01-2021

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

SAM Ultrasound Device and Diclofenac Patch

Experimental group

Description:

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Treatment:

Device: Sustained Acoustic Device with 2.5% Diclofenac Patch

SAM2 Ultrasound Device and Diclofenac Patch

Experimental group

Description:

Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Treatment:

Device: Sustained Acoustic Device with 2.5% Diclofenac Patch

Topical Pain-Relief Gel

Placebo Comparator group

Description:

Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.

Treatment:

Drug: 1% Diclofenac Topical Gel