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Device
SAM + Diclofenac for Broken Bone Pain
Phase 1
Recruiting
Led By George K. Lewis, Ph.D.
Research Sponsored by ZetrOZ, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 12 weeks.
Awards & highlights
Study Summary
This trial aims to investigate if LITUS can reduce bone-fracture pain and speed up return to work over 12 weeks.
Who is the study for?
This trial is for adults aged 18-80 with a physician-diagnosed bone fracture, experiencing moderate pain that affects their quality of life. Participants must not use other pain treatments or start new medications during the study and should be able to apply the treatment themselves.Check my eligibility
What is being tested?
The trial tests if Sustained Acoustic Medicine (SAM), combined with a Diclofenac patch, can reduce pain from bone fractures over 12 weeks better than just the Diclofenac patch alone. It also looks at whether SAM helps patients return to work sooner.See study design
What are the potential side effects?
Potential side effects may include skin irritation where the device or patch is applied, possible discomfort from using the device, and typical side effects of Diclofenac like digestive issues or local skin reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, average of 12 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 12 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline
Trial Design
1Treatment groups
Experimental Treatment
Group I: SAM Ultrasound Device and Diclofenac PatchExperimental Treatment2 Interventions
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm^2 intensity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sustained Acoustic Device with 2.5% Diclofenac Patch
2022
Completed Phase 2
~290
2.5% Diclofenac Patches
2023
Completed Phase 2
~200
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ZetrOZ, Inc.Lead Sponsor
15 Previous Clinical Trials
1,175 Total Patients Enrolled
George K. Lewis, Ph.D.Principal InvestigatorZetrOZ Systems
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to walk.My fracture pain lowers my quality of life.I cannot put on or take off the device by myself.I have cancer in the area that will be treated.I have a diagnosed nerve condition.I have a genetic condition that causes excessive bleeding.I agree to stop any other treatments like TENS or ultrasound on the affected area during the study.I have a bone fracture diagnosed by a doctor.I am between 18 and 80 years old.I am not using and will not start using opioid or non-opioid painkillers.I agree not to use any skin products other than what's given to me in the study.I can take my treatment by myself every day, except when I'm in water.I have an infection or open wounds in the area that would be treated.I have numbness in the area to be treated, possibly due to chemotherapy or anesthesia.I am currently on steroids.
Research Study Groups:
This trial has the following groups:- Group 1: SAM Ultrasound Device and Diclofenac Patch
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does my profile meet the criteria for being admitted into this medical experiment?
"This medical study has a capacity of 90 individuals and is accepting applications from adults between the ages 18 to 80 with broken bones."
Answered by AI
Is this experiment open to participants aged 50 and above?
"This clinical trial restricts enrolment to those aged 18-80. Separate trials are available for individuals younger than 18 and senior citizens over 65, with 68 and 298 programs respectively."
Answered by AI
To whom is this opportunity currently available?
"According to clinicaltrials.gov, this particular medical study is not presently accepting new participants as the trial was last updated on May 20th of this year (2023). Although recruitment for this specific research has been suspended, 359 other trials are actively searching for volunteers."
Answered by AI
What risks have been associated with the SAM Ultrasound Device and Diclofenac Patch in patient trials?
"The safety of SAM Ultrasound Device and Diclofenac Patch is rated a 1 on our scale due to the limited data available from Phase 1 trials indicating its efficacy and security."
Answered by AI
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