Low Intensity Ultrasound Therapy for Upper Back Pain Relief
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 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.
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.
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 medically necessary to ensure patient
 safety.

 -  Subjects who refuse to agree to not use any cream, gel, or topical solution during the
 administration of treatment other than the approved ultrasound gel provided to the
 subject at the initiation of the study.

 -  Subjects who refuse to discontinue massage therapy or spinal manipulation during the
 duration of this study.

 -  Subjects who have had massage therapy within 1 day of beginning the protocol

 -  Subjects who refuse to discontinue all other interventional treatment modalities (i.e.
 transcutaneous electrical nerve stimulation (TENS), ultrasound)

 -  Subjects who had a local corticosteroid or PRP (platelet-rich plasma) injection within
 the past 3 months.

 -  Subjects who have a clinically significant or unstable medical or psychological
 conditions that would compromise participation in the study.

 -  Subjects who have participated in another clinical trial for an investigational drug
 and/or agent within 30 days prior to screening.

 -  Subjects involved in any injury-related litigation in the target area.

 -  Subjects with abnormal neurological history, lumbar radicular symptoms, spinal
 stenosis, foot drop, herniated nucleus pulposus (gel-like substance within a spinal
 disc), or other structural defects.

 -  Subjects with back pain related to major trauma in the last 6 months

 -  Subjects with open sores or wounds in the treatment area that would prevent use of the
 device