Actively Recruiting
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
Led by ZetrOZ, Inc. · Updated on 2025-02-28
90
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.
CONDITIONS
Official Title
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
ZetrOZ Systems LLC
Trumbull, Connecticut, United States, 06611
Actively Recruiting
2
National Sports Medicine Institute
Lansdowne, Virginia, United States, 20176
Actively Recruiting
Research Team
G
George K. Lewis, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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