Long Duration Therapeutic Ultrasound for Tendon Healing

January 29, 2017 updated by: ZetrOZ, Inc.
ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • ZetrOZ, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • 18-65 years of age, inclusive
  • Diagnosis of tendinitis in the elbow (lateral or medial epicondyle), Achilles tendon, or patellar tendon based on examination of medical history and confirmed by physical examination including either manual movements of the injured limb, e.g., a positive Mill's Test for elbow tendinitis, or local tenderness upon palpation of the tendon;
  • Body mass index (BMI) less than or equal to 30.0
  • Not taking NSAIDs or prescription pain medications for their tendinitis, and agree to document all pain medication use during the study period.

Exclusion Criteria:

  • History or current diagnosis of tendon tear in treated tendon
  • Known neuropathy
  • Type I or Type II diabetes mellitus
  • Had surgery in target treatment area within 6 months
  • Refuse to agree to not increase current use or initiate new use of pain medication during the trial unless medically necessary to ensure patient safety
  • Refuse to agree to not use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided
  • Refuse to discontinue all other interventional treatment modalities (e.g., transcutaneous electrical nerve stimulation, other ultrasound therapy, etc.)
  • Have had a local corticosteroid or platelet-rich plasma injection within the past 3 months
  • Have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAM Ultrasound Diathermy Device
SAM (sam Professional System) 3 MHz ultrasound diathermy device: 4 hours/day, at least 5 days per week, for 6 weeks
Device: SAM Ultrasound Diathermy Device
Other Names:
  • sustained acoustic medicine
  • SAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain (Numeric Rating Scale; NRS)
Time Frame: Change from Baseline to Week 6
Change from Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain (NRS): 50% response rate
Time Frame: Week 6
Week 6
Pain (NRS) during treatment session
Time Frame: Pre-treatment to Post-treatment (4 hours)
Pre-treatment to Post-treatment (4 hours)
Grip Strength (dynamometer)
Time Frame: Change from Baseline to Week 6
Change from Baseline to Week 6
Treatment Compliance (subject-reported use of device compared to protocol)
Time Frame: weekly through Week 6
weekly through Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZetrOZ, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 29, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TN-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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