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Long Duration Therapeutic Ultrasound on Tendon Injuries

Primary Purpose

Tendon Injuries, Musculoskeletal Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic ultrasound
Placebo therapeutic ultrasound
Sponsored by
ZetrOZ, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendon Injuries focused on measuring tendinopathy, ultrasound, pain, heat, strength, LITUS, long duration, therapeutic ultrasound, tendonopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Clinical Research Consulting
  • Zetroz, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Therapeutic ultrasound device

Placebo therapeutic ultrasound device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in pain on the visual analog scale (VAS) from baseline to study conclusion

Secondary Outcome Measures

Pressure point sensitivity as measured through algometry
Change in pain during functional testing as measured by VAS
Change in strength of limb through dynamometry
Quality of life and functioning through limb-specific standardized questionnaires

Full Information

First Posted
January 12, 2015
Last Updated
January 29, 2017
Sponsor
ZetrOZ, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02340273
Brief Title
Long Duration Therapeutic Ultrasound on Tendon Injuries
Official Title
Long Duration Therapeutic Ultrasound on Tendon Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZetrOZ, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injuries, Musculoskeletal Pain
Keywords
tendinopathy, ultrasound, pain, heat, strength, LITUS, long duration, therapeutic ultrasound, tendonopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic ultrasound device
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo therapeutic ultrasound device
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Therapeutic ultrasound
Other Intervention Name(s)
Therapeutic ultrasound (active), wearable ultrasound device, long duration ultrasound, LITUS device, long duration low intensity device
Intervention Description
Patients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
Intervention Type
Device
Intervention Name(s)
Placebo therapeutic ultrasound
Intervention Description
Patients receive "sham" therapeutic ultrasound daily for 4 hours.
Primary Outcome Measure Information:
Title
Change in pain on the visual analog scale (VAS) from baseline to study conclusion
Time Frame
Baseline, Week 7
Secondary Outcome Measure Information:
Title
Pressure point sensitivity as measured through algometry
Time Frame
Baseline, Week 7
Title
Change in pain during functional testing as measured by VAS
Time Frame
Baseline, Week 7
Title
Change in strength of limb through dynamometry
Time Frame
Baseline, Week 7
Title
Quality of life and functioning through limb-specific standardized questionnaires
Time Frame
Baseline, Week 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George K Lewis, PhD
Organizational Affiliation
Sponsor GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Consulting
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Zetroz, Inc
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States

12. IPD Sharing Statement

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Long Duration Therapeutic Ultrasound on Tendon Injuries

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