Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture

Launched by ZETROZ, INC. · May 20, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called long-duration low-intensity therapeutic ultrasound (LITUS) to help relieve pain from bone fractures. The study aims to see if this treatment can effectively reduce pain over a 12-week period and help patients return to work more quickly. If you or a loved one has a diagnosed bone fracture, is between 18 and 80 years old, and is experiencing moderate pain that affects daily life, you might be eligible to participate in this study.

Participants will use the ultrasound device daily at home, and they will be asked to avoid using other pain relief treatments during the study. It's important to know that certain conditions, like having an active infection or being pregnant, could prevent someone from joining the trial. Overall, this study seeks to find a new way to help manage pain from bone fractures, which could improve quality of life for many people.

Gender

ALL

Eligibility 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.