Using low-intensity ultrasound to relieve pain from bone fractures
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
PHASE1 · ZetrOZ, Inc. · NCT05883241
This study is testing if a special ultrasound device combined with a pain patch can help people with painful bone fractures feel better over 12 weeks.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | ZetrOZ, Inc. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Trumbull, Connecticut and 1 other locations) |
| Trial ID | NCT05883241 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a Sustained Acoustic Medicine (SAM) device combined with a diclofenac patch in alleviating pain associated with bone fractures over a 12-week period. Participants will self-administer the treatment for four hours daily while reporting their pain scores before, during, and after treatment. The study aims to recruit over 90 subjects from local communities, focusing on those who experience significant pain affecting their quality of life. The primary goal is to assess the analgesic effects of low-intensity therapeutic ultrasound on fracture-related pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with physician-diagnosed bone fractures and moderate pain levels that impact their quality of life.
Not a fit: Patients with severe pain requiring opioid analgesics or those currently using other interventional treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and effective pain management option for patients with bone fractures.
How similar studies have performed: While the use of low-intensity ultrasound for pain management is emerging, this specific combination of SAM and diclofenac is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have physician-diagnosed bone fracture * Are between 18-80 years of age * Report a pain score between 3-7 (range: 0-10) prior to enrolment * Report that pain from fracture 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 affected 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. * 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). * Are currently taking steroids.
Where this trial is running
Trumbull, Connecticut and 1 other locations
- ZetrOZ Systems LLC — Trumbull, Connecticut, United States (RECRUITING)
- National Sports Medicine Institute — Lansdowne, Virginia, 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.
Conditions: Bone Fracture, Fresh Fracture, Low-Intensity Ultrasound, Drug Delivery, Sonophoresis, Transdermal Drug Delivery, Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication