Long Duration Therapeutic Ultrasound on Tendon Injuries

January 29, 2017 updated by: ZetrOZ, Inc.
Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase tendon strength, and improve quality of life for patients with tendon injury.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The ability of long duration therapeutic ultrasound to reduce pain, increase strength, and improve quality of life for patients with tendon injury [e.g. tendinopathy of the elbow (medial or lateral], Achilles tendon, or patellar tendon) will be assessed. During the 7-week protocol, participants will receive 4 continuous hours of therapy daily.

For the first week, baseline data will be collected as participants report pain scores (VAS) in the morning, noon, and night. During the next 6 weeks, participants will self-apply the device each day and record their pain score (VAS) before and treatment; and record their pain score (VAS) while performing specified movements designed to evaluate tendon rehabilitation. At bi-weekly site visits, strength measurements will be performed on the injured and uninjured limb. Participants will also complete a standardized questionnaire to assess disability due to the specific tendon injury at baseline and study conclusion.

Study Type

Interventional

Enrollment (Actual)

13

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
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting
      • 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has been diagnosed with tendinitis in the elbow (medial or lateral epicondyles), patella, or Achilles tendon based on physical examination by a healthcare practitioner and medical history. Physical examination must include one of the following: assessment of pain during manual movements of the injured limb (e.g. a positive Mill's Test [Wadsworth, 1987] for elbow tendinitis), or local tenderness upon palpation over the tendon
  • Experience tendon pain greater than 1 (using the VAS scale of 0-10) during the week preceding study screening
  • Between 18 and 70 years of age
  • Willing and able to self-administer the study device to the treatment area daily
  • Have access to a mobile phone or camera to take a picture of the treatment area immediately after use of the device
  • Body Mass Index (BMI) is less than or equal to 34.0
  • Agree to document all pain medications and associated dosages during participation in the study.
  • If taking prescription pain medication, agree to keep dosage constant (unchanged) during participation in the study.
  • Agree not to use any topical solution such as analgesic cream or ointment on the treatment area during participation in the study

Exclusion Criteria:

  • Subjects that cannot speak, read or write English
  • History or current diagnosis of tendinosis or a tendon tear
  • Known neuropathy (nerve damage that affects the treatment area)
  • Surgery in the treatment area within the last 6 months
  • Non-ambulatory (unable to walk)
  • Prisoner
  • Pregnant
  • Have a pacemaker
  • Malignancy in the treatment area
  • Refuse to discontinue all other interventional treatment modalities (i.e. transcutaneous electrical nerve stimulation (TENS), electrical stimulation, or other ultrasound therapy) during the study
  • Local corticosteroid or platelet-rich plasma (PRP) injection within the past 3 months
  • Clinically significant or unstable medical or psychological conditions that would compromise participation in the study
  • Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
  • Involved in any injury-related litigation in the treatment area
  • Open sores or wounds in the treatment area that would prevent use of the device
  • Arthritis in the treatment area
  • Carpal tunnel syndrome (if subject has elbow tendinitis)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic ultrasound device
Patients receive treatment from the long duration therapeutic ultrasound device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Device: Therapeutic ultrasound
Patients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
Other Names:
  • wearable ultrasound device
  • long duration ultrasound
  • LITUS device
  • long duration low intensity device
  • Therapeutic ultrasound (active)
Placebo Comparator: Placebo therapeutic ultrasound device
Patients receive the "sham" long duration therapeutic ultrasound device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Device: Placebo therapeutic ultrasound
Patients receive "sham" therapeutic ultrasound daily for 4 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain on the visual analog scale (VAS) from baseline to study conclusion
Time Frame: Baseline, Week 7
Baseline, Week 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Pressure point sensitivity as measured through algometry
Time Frame: Baseline, Week 7
Baseline, Week 7
Change in pain during functional testing as measured by VAS
Time Frame: Baseline, Week 7
Baseline, Week 7
Change in strength of limb through dynamometry
Time Frame: Baseline, Week 7
Baseline, Week 7
Quality of life and functioning through limb-specific standardized questionnaires
Time Frame: Baseline, Week 7
Baseline, Week 7

Collaborators and Investigators

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

Sponsor

ZetrOZ, Inc.

Investigators

  • Principal Investigator: George K Lewis, PhD, Sponsor GmbH

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

December 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 29, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TN-02 (ZetrOZ-20140923)

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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