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Long Duration Therapeutic Ultrasound for Tendon Healing

Primary Purpose

Tendinopathy, Tendinitis, Tendinosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAM Ultrasound Diathermy Device
Sponsored by
ZetrOZ, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring sustained acoustic medicine, therapeutic ultrasound, SAM, LITUS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ZetrOZ, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAM Ultrasound Diathermy Device

Arm Description

SAM (sam Professional System) 3 MHz ultrasound diathermy device: 4 hours/day, at least 5 days per week, for 6 weeks

Outcomes

Primary Outcome Measures

Pain (Numeric Rating Scale; NRS)

Secondary Outcome Measures

Pain (NRS): 50% response rate
Pain (NRS) during treatment session
Grip Strength (dynamometer)
Treatment Compliance (subject-reported use of device compared to protocol)

Full Information

First Posted
June 3, 2015
Last Updated
January 29, 2017
Sponsor
ZetrOZ, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02466308
Brief Title
Long Duration Therapeutic Ultrasound for Tendon Healing
Official Title
Long Duration Therapeutic Ultrasound for Tendon Healing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Tendinitis, Tendinosis
Keywords
sustained acoustic medicine, therapeutic ultrasound, SAM, LITUS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAM Ultrasound Diathermy Device
Arm Type
Experimental
Arm Description
SAM (sam Professional System) 3 MHz ultrasound diathermy device: 4 hours/day, at least 5 days per week, for 6 weeks
Intervention Type
Device
Intervention Name(s)
SAM Ultrasound Diathermy Device
Other Intervention Name(s)
sustained acoustic medicine, SAM
Primary Outcome Measure Information:
Title
Pain (Numeric Rating Scale; NRS)
Time Frame
Change from Baseline to Week 6
Secondary Outcome Measure Information:
Title
Pain (NRS): 50% response rate
Time Frame
Week 6
Title
Pain (NRS) during treatment session
Time Frame
Pre-treatment to Post-treatment (4 hours)
Title
Grip Strength (dynamometer)
Time Frame
Change from Baseline to Week 6
Title
Treatment Compliance (subject-reported use of device compared to protocol)
Time Frame
weekly through Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ZetrOZ, Inc.
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26468991
Citation
Best TM, Moore B, Jarit P, Moorman CT, Lewis GK. Sustained acoustic medicine: wearable, long duration ultrasonic therapy for the treatment of tendinopathy. Phys Sportsmed. 2015 Nov;43(4):366-74. doi: 10.1080/00913847.2015.1095617. Epub 2015 Oct 15.
Results Reference
derived

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Long Duration Therapeutic Ultrasound for Tendon Healing

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