Clinical trial NCT02135094: Low Intensity Ultrasound Therapy for Upper Back Pain Relief
Official title: Short Term Effects of Long Duration Low Intensity Continuous Ultrasound for Trapezius Muscle Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Spasm
Keywords: trapezius
upper back
muscle pain
pain relief
ultrasound
double blind
Sam
ZetrOZ
muscle
LITUS
low intensity therapeutic ultrasound
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: 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
Secondary outcomes:
measure: Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.
timeFrame: Day 1 through Week 4
measure: Change in Pain Rated on Numeric Rating Scale (NRS) From Pre-treatment to 30 Minutes Into Treatment, 2 Hours Into Treatment, and Post-treatment (4 Hours Into Treatment)
timeFrame: Day 1 through Week 4
measure: Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
timeFrame: Week 1, Week 2, Week 3, Week 4, Overall
Other outcomes:
Locations:
city: Trumbull
country: United States
facility: ZetrOZ, Inc.
state: Connecticut
Study officials:
affiliation: ZetrOZ, Inc.
name: George K. Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petterson S, Plancher K, Klyve D, Draper D, Ortiz R. Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial. J Pain Res. 2020 Jun 2;13:1277-1287. doi: 10.2147/JPR.S247463. eCollection 2020.