Low Intensity Ultrasound Therapy for Upper Back Pain Relief

NCT02135094 | Completed Results

• 2 other identifiers: TP-02201306603
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasm

Keywords

trapezius; upper back; muscle pain; pain relief; ultrasound; double blind; Sam; ZetrOZ; muscle; LITUS; low intensity therapeutic ultrasound

Outcome Measures

Primary Outcomes (2)

• Pain on the Numeric Rating Scale (NRS)

  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.

  Week 1, Week 2, Week 3, Week 4

• Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.

  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.

  Day 1 through Week 1, Week 2, Week 3, and Week 4

Secondary Outcomes (3)

• Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.

  Day 1 through Week 4

• 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)

  Day 1 through Week 4

• Comparison of Pain Level Using Global Rating of Change (GROC) Scale.

  Week 1, Week 2, Week 3, Week 4, Overall

Study Arms (2)

Active ultrasound therapy device

EXPERIMENTAL

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

Device: Active ultrasound therapy device

Placebo ultrasound therapy device

PLACEBO COMPARATOR

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.

Device: Placebo ultrasound therapy device

Interventions

Active ultrasound therapy device DEVICE

low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day

Also known as: ZetrOZ ultrasound device, wearable ultrasound device, long duration ultrasound, LITUS device, long duration low intensity device

Active ultrasound therapy device

Placebo ultrasound therapy device DEVICE

The placebo device appears and operates identically to the active device except that it does not emit ultrasound.

Also known as: ZetrOZ ultrasound device, wearable ultrasound device, long duration ultrasound, LITUS device, long duration low intensity device

Placebo ultrasound therapy device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (1)

ZetrOZ, Inc.

Trumbull, Connecticut, 06611, United States

Location

Related Publications (1)

• 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.

  PMID: 32606899 DERIVED

MeSH Terms

Conditions

Spasm; Myalgia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Pain

Results Point of Contact

• Title: Dr. Ralph Ortiz
• Organization: Pain Management Associates

rodoc@cnymail.com

(607) 844-9979

Study Officials

• George K. Lewis, PhD

  ZetrOZ, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 9, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 2, 2020
• Results First Posted: June 11, 2018

Record last verified: 2020-03

Locations

US (1)