Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Knee Osteoarthritis Clinical Trial

Official title:

Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254574
• Other study ID #: OA-01-2022
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2022
• Est. completion date: February 28, 2023

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 compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of knee osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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 35-80 years of age
• Report a frequent pain score between 3-7 (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 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 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 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.
• Placebo Sustained Acoustic Device with 0% Diclofenac Patch
Patients apply the placebo SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% Diclofenac patches.

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

Locations

Country	Name	City	State
United States	James A Haley Veterans Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ZetrOZ, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Best TM, Petterson S, Plancher K. Sustained acoustic medicine as a non-surgical and non-opioid knee osteoarthritis treatment option: a health economic cost-effectiveness analysis for symptom management. J Orthop Surg Res. 2020 Oct 19;15(1):481. doi: 10.1186/s13018-020-01987-x. — View Citation

Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018 Oct 16;13(1):257. doi: 10.1186/s13018-018-0965-0. — View Citation

Langer MD, Levine V, Taggart R, Lewis GK, Hernandez L, Ortiz R. Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis. Proc IEEE Annu Northeast Bioeng Conf. 2014 Apr;2014:14789673. doi: 10.1109/NEBEC.2014.6972850. — View Citation

Madzia A, Agrawal C, Jarit P, Petterson S, Plancher K, Ortiz R. Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18. — View Citation

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).	Time Frame: Through study completion, average of 8 weeks