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NCT02135094 · ClinicalTrials.gov registry record · NA
Low Intensity Ultrasound Therapy for Upper Back Pain Relief
A NA study, sponsored by ZetrOZ.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT02135094 is a NA study that has completed, run by ZetrOZ. The registered enrollment target is 33 participants.
The verdict
NCT02135094, a NA study, has completed, sponsored by ZetrOZ.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Active ultrasound therapy device
- DEVICE Placebo ultrasound therapy device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02135094
The ClinicalTrials.gov registry entry for NCT02135094 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ZetrOZ, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active ultrasound therapy device is the first listed.
NCT02135094 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02135094 about?
NCT02135094 is a clinical study titled "Low Intensity Ultrasound Therapy for Upper Back Pain Relief". 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 po...
What is the current status of trial NCT02135094?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2014-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02135094?
The interventions under investigation include: Active ultrasound therapy device (DEVICE), Placebo ultrasound therapy device (DEVICE).
Who is sponsoring clinical trial NCT02135094?
This trial is sponsored by ZetrOZ, which has 17 total clinical trials registered on ClinicalTrials.gov.
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