Low Intensity Ultrasound Therapy for Upper Back Pain Relief
Condition: Muscle Spasm
MeSH terms: Spasm
Study type: Interventional

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.
    

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.
    

Intervention name(s): Active ultrasound therapy device; Placebo ultrasound therapy device
Intervention type(s): Device; Device
Intervention description(s): low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day; The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Other intervention name(s): ZetrOZ ultrasound device; wearable ultrasound device; long duration ultrasound; LITUS device; long duration low intensity device; ZetrOZ ultrasound device; wearable ultrasound device; long duration ultrasound; LITUS device; long duration low intensity device
Intervention MeSH terms: Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trapezius; upper back; muscle pain; pain relief; ultrasound; double blind; Sam; ZetrOZ; muscle; LITUS; low intensity therapeutic ultrasound