Skip to main content
OpenTrials
Completed

NCT Number: NCT02466308

Long Duration Therapeutic Ultrasound for Tendon Healing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinitis Tendinosis Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZetrOZ, Inc.

Trumbull, Connecticut, 06611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAM Ultrasound Diathermy Device

Device

Other names: sustained acoustic medicine, SAM

Primary outcomes

  1. Pain (Numeric Rating Scale; NRS)

    Time frame: Change from Baseline to Week 6

Secondary outcomes

  1. Pain (NRS): 50% response rate

    Time frame: Week 6

  2. Pain (NRS) during treatment session

    Time frame: Pre-treatment to Post-treatment (4 hours)

  3. Grip Strength (dynamometer)

    Time frame: Change from Baseline to Week 6

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

    Time frame: weekly through Week 6

Sponsors and collaborators

Lead sponsor

ZetrOZ, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 9, 2015
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.