Long Duration Therapeutic Ultrasound for Tendon Healing

Tendinopathy Clinical Trial

Official title:

Long Duration Therapeutic Ultrasound for Tendon Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466308
• Other study ID #: TN-01
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: January 29, 2017
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: ZetrOZ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinitis
• Tendinopathy
• Tendinosis

Intervention

Device:
• SAM Ultrasound Diathermy Device

Locations

Country	Name	City	State
United States	ZetrOZ, Inc.	Trumbull	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ZetrOZ, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (Numeric Rating Scale; NRS)		Change from Baseline to Week 6
Secondary	Pain (NRS): 50% response rate		Week 6
Secondary	Pain (NRS) during treatment session		Pre-treatment to Post-treatment (4 hours)
Secondary	Grip Strength (dynamometer)		Change from Baseline to Week 6
Secondary	Treatment Compliance (subject-reported use of device compared to protocol)		weekly through Week 6