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Low Intensity Ultrasound Therapy for Upper Back Pain Relief

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ClinicalTrials.gov Identifier: NCT02135094
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : June 11, 2018
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
ZetrOZ, Inc.

Tracking Information
First Submitted Date  ICMJE May 2, 2014
First Posted Date  ICMJE May 9, 2014
Results First Submitted Date  ICMJE May 9, 2018
Results First Posted Date  ICMJE June 11, 2018
Last Update Posted Date April 2, 2020
Study Start Date  ICMJE June 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • Pain on the Numeric Rating Scale (NRS) [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]
    Patients applied the ultrasound device when trapezius muscle pain exceeds a score of 3 or higher by numeric rating scale (NRS). NRS range was 0-10 with 0 being no pain and 10 the worst pain possible. Device maybe be worn safely for 4 h per day for 7 days a week. Participants recorded NRS score daily (pre-treatment) and on days when the device was applied participants recorded pain 30 minutes into treatment, 2 hours into treatment and post-treatment (after 4 hours). The post-treatment score is used to find the week average and standard deviation.
  • Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment. [ Time Frame: Day 1 through Week 1, Week 2, Week 3, and Week 4 ]
    The Day 1 pre-treatment score was used to find the change in pain each week, rated on the numeric rating scale (NRS). NRS was rated from 0-10 with 0 being in no pain and 10 the worst pain possible. Weekly averaged post-treatment scores were subtracted from Day 1 pre-treatment score.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
Change in pain on the visual analog scale (VAS) [ Time Frame: Baseline, Week 2, Week 4 ]
Patients apply the ultrasound device when trapezius muscle pain exceeds a score of 3 or higher by VAS. Device maybe be worn safely for 4 h per day for 7 days a week. Patients record VAS score on days when the device is applied - before treatment, during treatment, and after treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment. [ Time Frame: Day 1 through Week 4 ]
    Participants recorded pain rated on the numeric rating scale (NRS) at 4 time points: before treatment, 30 minutes into treatment, 2 hours into treatment, and directly after treatment. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. The average time point scores across the study is used to assess pain during treatment.
  • 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) [ Time Frame: Day 1 through Week 4 ]
    The numeric rating scale (NRS) was used to assess pain before treatment, 30 minutes into treatment, 2 hours into treatment, and post-treatment. NRS range was from 0-10 with 0 being in no pain and 10 the worst pain possible. Change in pain was calculated by subtracting intra-treatment and post-treatment average scores from pre-treatment average score.
  • Comparison of Pain Level Using Global Rating of Change (GROC) Scale. [ Time Frame: Week 1, Week 2, Week 3, Week 4, Overall ]
    Participants were asked to report how their body feels overall compared to the day before, on days when the ultrasound device (or placebo) were applied. The score was reported after the 4-hour treatment completion and rated on a 15-point global rating of change scale, with -7 being "a very great deal worse" than the day before, 0 being "no change" from the day before, and +7 being "a very great deal better" than the day before. The weekly average GROC and average GROC for the entire study (Overall) were assessed.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • Comparison of pain level using Global Rating of Change (GROC) scale. [ Time Frame: Baseline, Week 2, Week 4 ]
    GROC score will be recorded daily after treatment. Scores will be compared for baseline, Week 2, and Week 4
  • Change in trigger point depth [ Time Frame: Baseline, Week 2, Week 4 ]
    The certified examiner will measure depth at each trigger point location with a pressure algometer. The examiner will identify 2 trigger points on the subject's left and right upper trapezius muscle and place the algometer at the location. The examiner will apply small amounts of pressure to the algometer to measure the tightness of the muscle.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Intensity Ultrasound Therapy for Upper Back Pain Relief
Official Title  ICMJE Short Term Effects of Long Duration Low Intensity Continuous Ultrasound for Trapezius Muscle Pain
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Muscle Spasm
Intervention  ICMJE
  • Device: Active ultrasound therapy device
    low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
    Other Names:
    • ZetrOZ ultrasound device
    • wearable ultrasound device
    • long duration ultrasound
    • LITUS device
    • long duration low intensity device
  • Device: Placebo ultrasound therapy device
    The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
    Other Names:
    • ZetrOZ ultrasound device
    • wearable ultrasound device
    • long duration ultrasound
    • LITUS device
    • long duration low intensity device
Study Arms  ICMJE
  • Experimental: Active 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
    Intervention: Device: Active ultrasound therapy device
  • Placebo Comparator: Placebo ultrasound therapy device
    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.
    Intervention: Device: Placebo ultrasound therapy device
Publications * 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. Erratum in: J Pain Res. 2020 Jul 27;13:1899-1900.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2018)
33
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
60
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135094
Other Study ID Numbers  ICMJE TP-02
201306603 ( Other Identifier: Schulman Associates IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZetrOZ, Inc.
Study Sponsor  ICMJE ZetrOZ, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: George K. Lewis, PhD ZetrOZ, Inc.
PRS Account ZetrOZ, Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP