Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT02135094
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2014-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Intensity Ultrasound Therapy for Upper Back Pain Relief
Sponsor:
ZetrOZ, Inc.
Organization:
Study Overview
Official Title:
Short Term Effects of Long Duration Low Intensity Continuous Ultrasound for Trapezius Muscle Pain
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device for relief of pain associated with the trapezius muscle of the upper back over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers most of the upper back and the posterior of the neck.The hypothesis is that the ultrasound device will lower the reported daily pain level of subjects suffering from trapezius muscle pain in their upper back.
Subjects who participate in the study will self-administer the ultrasound device daily if pain is rated 3.0 or higher on the numeric rating scale (0-10). Subjects will be required to visit the clinical site at enrollment and weeks 2 and 4 for a total of 3 visits. Subjects will report their daily pain levels in a diary. Subject will also report pain levels at 30 min, 2 hours, and 4 hours (treatment completion) after start of each treatment.
The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of joint contracture, relief of muscle spasm, and increased circulation.
Subjects who participate in the study will self-administer the ultrasound device daily if pain is rated 3.0 or higher on the numeric rating scale (0-10). Subjects will be required to visit the clinical site at enrollment and weeks 2 and 4 for a total of 3 visits. Subjects will report their daily pain levels in a diary. Subject will also report pain levels at 30 min, 2 hours, and 4 hours (treatment completion) after start of each treatment.
The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of joint contracture, relief of muscle spasm, and increased circulation.
Detailed Description:
The study will have approximately 33 subjects randomly assigned into a user group (active ultrasound device) of 25 participants or a control group (inactive ultrasound device) of 8 participants with an equal number of males and females in each group. The research coordinator will be blinded to the assignment of devices to each group.
The daily pain scores reported by patients who receive active devices will be compared to those who receive placebo devices.
Background:
Approximately 50 to 80 million people in the United States suffer from some form of chronic pain. Back pain is the most common neurological disorder in the United States after headaches and costs consumers nearly $50 billion annually. Pharmaceuticals currently dominate the treatment options despite a myriad of public health problems including cost, untoward side effects, and addiction to widely available opioid analgesics. Non-pharmaceutical treatments, such as the one under test, provide a safer and potentially lower cost alternative to traditional analgesic use.
The daily pain scores reported by patients who receive active devices will be compared to those who receive placebo devices.
Background:
Approximately 50 to 80 million people in the United States suffer from some form of chronic pain. Back pain is the most common neurological disorder in the United States after headaches and costs consumers nearly $50 billion annually. Pharmaceuticals currently dominate the treatment options despite a myriad of public health problems including cost, untoward side effects, and addiction to widely available opioid analgesics. Non-pharmaceutical treatments, such as the one under test, provide a safer and potentially lower cost alternative to traditional analgesic use.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 201306603 | OTHER | Schulman Associates IRB | View |