NCT02466308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
Last Updated

January 31, 2017

Status Verified

June 1, 2015

Enrollment Period

7 months

First QC Date

June 3, 2015

Last Update Submit

January 29, 2017

Conditions

TendinopathyTendinitisTendinosis

Keywords

sustained acoustic medicinetherapeutic ultrasoundSAMLITUS

Outcome Measures

Primary Outcomes (1)

  • Pain (Numeric Rating Scale; NRS)

    Change from Baseline to Week 6

Secondary Outcomes (4)

  • Pain (NRS): 50% response rate

    Week 6

  • Pain (NRS) during treatment session

    Pre-treatment to Post-treatment (4 hours)

  • Grip Strength (dynamometer)

    Change from Baseline to Week 6

  • Treatment Compliance (subject-reported use of device compared to protocol)

    weekly through Week 6

Study Arms (1)

SAM Ultrasound Diathermy Device

EXPERIMENTAL

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

Interventions

SAM Ultrasound Diathermy DeviceDEVICE
Also known as: sustained acoustic medicine, SAM
SAM Ultrasound Diathermy Device

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZetrOZ, Inc.

Trumbull, Connecticut, 06611, United States

Location

Related Publications (1)

  • 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.

    PMID: 26468991DERIVED

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 9, 2015

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 31, 2017

Record last verified: 2015-06

Locations

US(1)