Clinical trial NCT05883241: Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
Official title: Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Bone Fracture
Fresh Fracture
Keywords: Low-Intensity Ultrasound
Drug Delivery
Sonophoresis
Transdermal Drug Delivery
Non-Steroidal Anti-Inflammatory Drugs
Sustained Acoustic Medication
Low-Intensity Continuous Ultrasound
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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 at the completion of treatment.

Over 90 subjects will be recruited from neighboring communities to the study site(s). The study is designed to reach a diverse target patient population.

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.

Primary outcomes:
measure: Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline
timeFrame: Through study completion, average of 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Trumbull
country: United States
facility: ZetrOZ Systems LLC
state: Connecticut
city: Lansdowne
country: United States
facility: National Sports Medicine Institute
state: Virginia
Study officials:
affiliation: ZetrOZ Systems
name: George K. Lewis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: