Clinical trial NCT05254574: Sustained Acoustic Medicine for Osteoarthritis Pain
Official title: Sustained Acoustic Medicine for Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: Continuous ultrasound
Sustained Acoustic Medicine
Musculoskeletal Injuries
Low Intensity Continuous Ultrasound
Pain
Joint Injury
Osteoarthritis
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.


Eligibility criteria: Inclusion Criteria:

* Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).
* Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
* Are between 35-85 years of age
* Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment
* Report that knee, shoulder, elbow, ankle, hip, or spine 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 treatment area 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.
* 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, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months.
* Requires oxygen support
* Has an allergy to aspirin or other NSAIDs
* 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: Through study completion, average of 8 weeks
measure: Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Time Frame: Through study completion, average of 8 weeks
Secondary outcomes:
measure: Change in Global Rating of Change (GROC) on a Scale (-7 to +7)
timeFrame: Through study completion, average of 24 weeks.
measure: Change in the Pain & Sleep Questionnaire (PSQ-3)
timeFrame: Through study completion, average of 24 weeks.
measure: Change in Depression Anxiety Stress Scale (DASS21)
timeFrame: Through study completion, average of 24 weeks.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A Haley Veterans Hospital
state: Florida
Study officials:
affiliation: James A. Haley Veterans Hospital
name: Sandra Winkler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.