Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02466308
Other study ID # TN-01
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT03307499 - NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery N/A
Completed NCT02499484 - Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy N/A
Completed NCT01944150 - Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis N/A
Recruiting NCT04578418 - Effect of Collagen Supplementation on Tendinopathy N/A
Completed NCT03262181 - The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy N/A
Completed NCT03502434 - A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers Phase 1
Recruiting NCT04278833 - Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions Phase 4
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Recruiting NCT05603468 - Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair Phase 4
Terminated NCT01544244 - The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis N/A
Recruiting NCT04144946 - Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
Terminated NCT02978833 - Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy Phase 4
Completed NCT03229291 - A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects Phase 1
Recruiting NCT06056440 - Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab) N/A
Recruiting NCT04058509 - Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain N/A
Withdrawn NCT02981394 - Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Active, not recruiting NCT02600910 - Natural History of Shoulder Pathology in Manual Wheelchair Users
Completed NCT04793971 - Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
Not yet recruiting NCT01225497 - Eccentric Exercise for Chronic Mid-portion Achilles Tendinopathy N/A