Long Duration Therapeutic Ultrasound for Tendon Healing

NCT ID: NCT02466308

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-09-30

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.

Conditions

Tendinopathy; Tendinitis; Tendinosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAM Ultrasound Diathermy Device

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

Group Type: EXPERIMENTAL

SAM Ultrasound Diathermy Device

Intervention Type: DEVICE

Interventions

SAM Ultrasound Diathermy Device

Intervention Type: DEVICE

Other Intervention Names

sustained acoustic medicine; SAM

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZetrOZ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ZetrOZ, Inc.

Trumbull, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26468991 (View on PubMed)

Other Identifiers

TN-01

Identifier Type: -

Identifier Source: org_study_id