Using low-intensity ultrasound to treat knee pain from osteoarthritis
Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
This study is testing if a new ultrasound device paired with a pain medication can help people with knee pain from osteoarthritis feel better and improve their daily life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | ZetrOZ, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Stamford, Connecticut and 2 other locations) |
| Trial ID | NCT06257537 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a wireless Sustained Acoustic Medicine (SAM) device combined with diclofenac for alleviating knee pain in patients with osteoarthritis over a 24-week period. Participants will self-administer the treatment daily for four hours, while their pain scores and quality of life will be assessed at various intervals. The study aims to recruit over 300 subjects, focusing on rural and socioeconomically disadvantaged individuals. The primary goal is to determine the analgesic effect of the treatment, with secondary objectives including improvements in joint function.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-85 with mild to moderate knee osteoarthritis who experience frequent pain affecting their quality of life.
Not a fit: Patients with severe knee osteoarthritis or those currently using other analgesic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce knee pain and improve quality of life for patients with osteoarthritis.
How similar studies have performed: Other studies using low-intensity ultrasound for pain management have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 50-85 years of age * Report a frequent pain score between 4-7 (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 ultrasound gel 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 use of 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 any contraindication to radiograph. * Have a secondary cause of arthritis (metabolic or inflammatory).
Where this trial is running
Stamford, Connecticut and 2 other locations
- Orthopaedic Foundation — Stamford, Connecticut, United States (Recruiting)
- ZetrOZ Systems — Trumbull, Connecticut, United States (Recruiting)
- Cayuga Medical Center - Medical Pain Consultants — Dryden, New York, United States (Recruiting)
Study contacts
- Principal investigator: George K Lewis, Ph.D. — ZetrOZ Systems
- Study coordinator: George K Lewis, Ph.D.
- Email: george@zetroz.com
- Phone: 8882029831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.