Low Intensity Ultrasound Therapy for Upper Back Pain Relief
Muscle Spasm
About this trial
This is an interventional treatment trial for Muscle Spasm focused on measuring trapezius, upper back, muscle pain, pain relief, ultrasound, double blind, Sam, ZetrOZ, muscle, LITUS, low intensity therapeutic ultrasound
Eligibility Criteria
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
Sites / Locations
- ZetrOZ, Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active ultrasound therapy device
Placebo ultrasound therapy device
Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity
Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.