Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZetrOZ, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sustained Acoustic Device with 2.5% Diclofenac Patch
DevicePatients 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.
2.5% Diclofenac Patches
DrugTopical pain relief-gel worn during treatment via SAM patch.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: SAM Ultrasound Device and Diclofenac PatchExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline
Change in the self-described pain units on a scale by patient at baseline and post-treatment.
Time frame
Through study completion, average of 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov