Low Intensity Ultrasound Therapy for Upper Back Pain Relief (NCT02135094) | Clinical Trial Compass
CompletedNot Applicable
Low Intensity Ultrasound Therapy for Upper Back Pain Relief
United States33 participantsStarted 2014-06
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between the ages of 18 and 65 years.
* Has acute trapezius muscle pain that has been assessed by a health care practitioner.
* Has a NRS pain severity score of 3.0 or higher in the trapezius muscle 3-4 times over the past week prior to enrolling in the trial.
* Subjects must 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 device under test.
* Not taken any prescription pain medications or muscle relaxers in the 5 days prior to the study and agree not to take any during the study and to maintain any dosage of NSAIDs (nonsteroidal antiinflammatory drug) or non-prescription pain medications constant during the study
* Has access to a mobile phone or camera and the help of another individual to take a picture of the upper back area immediately after use of the device
Exclusion Criteria:
* Subjects with known neuropathy will be excluded from the study
* Women who are pregnant may not participate.
* Prisoners
* Smokers
* Subjects with Type I or Type II Diabetes
* Subjects who have had surgery in the target area within the last 6 months will be excluded from the study.
* Subjects who are non-ambulatory (i.e. who cannot walk) will be excluded from the study.
* Subjects who refuse to agree to not increase current use or initiate new use of pain medication during the course of the trial unless medi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain on the Numeric Rating Scale (NRS)
Timeframe: Week 1, Week 2, Week 3, Week 4
2
Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.
Timeframe: Day 1 through Week 1, Week 2, Week 3, and Week 4