Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
ZetrOZ, Inc.
Summary
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.
Description
This is a 12-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from pain related to a bone fracture(s). The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 12 weeks, patients will self-apply their treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device, during treatment, and…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
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 o…
Interventions
- DeviceSustained Acoustic Device with 2.5% Diclofenac Patch
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3-megahertz (MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.
- Drug2.5% Diclofenac Patches
Topical pain relief-gel worn during treatment via SAM patch.
Locations (2)
- ZetrOZ Systems LLCTrumbull, Connecticut
- National Sports Medicine InstituteLansdowne, Virginia