Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
Recruiting
Phase 1
Interventional Study
Bone Fracture
Fresh Fracture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- ZetrOZ, Inc. · Industry
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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 tim…
Trial Locations
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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 th…
Contacts