Clinical trial NCT02466308: Long Duration Therapeutic Ultrasound for Tendon Healing
Official title: Long Duration Therapeutic Ultrasound for Tendon Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Tendinitis
Tendinosis
Keywords: sustained acoustic medicine
therapeutic ultrasound
SAM
LITUS
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain (Numeric Rating Scale; NRS)
timeFrame: Change from Baseline to Week 6
Secondary outcomes:
measure: Pain (NRS): 50% response rate
timeFrame: Week 6
measure: Pain (NRS) during treatment session
timeFrame: Pre-treatment to Post-treatment (4 hours)
measure: Grip Strength (dynamometer)
timeFrame: Change from Baseline to Week 6
measure: Treatment Compliance (subject-reported use of device compared to protocol)
timeFrame: weekly through Week 6
Other outcomes:
Locations:
city: Trumbull
country: United States
facility: ZetrOZ, Inc.
state: Connecticut
Study officials:
References:
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.