Long Duration Therapeutic Ultrasound on Tendon Injuries

Stopped early · Not applicable · Has a placebo group

Conditions studied: Tendon Injuries, Musculoskeletal Pain

In brief

Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase tendon strength, and improve quality of life for patients with tendon injury.

Key facts

Study ID

NCT02340273

Run by

ZetrOZ, Inc.

People needed

13

Starts

2014-12-01

Expected to finish

2015-09-01

Last updated by the study team

2017-01-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has been diagnosed with tendinitis in the elbow (medial or lateral epicondyles), patella, or Achilles tendon based on physical examination by a healthcare practitioner and medical history. Physical examination must include one of the following: assessment of pain during manual movements of the injured limb (e.g. a positive Mill's Test [Wadsworth, 1987] for elbow tendinitis), or local tenderness upon palpation over the tendon
• Experience tendon pain greater than 1 (using the VAS scale of 0-10) during the week preceding study screening
• Between 18 and 70 years of age
• Willing and able to self-administer the study device to the treatment area daily
• Have access to a mobile phone or camera to take a picture of the treatment area immediately after use of the device
• Body Mass Index (BMI) is less than or equal to 34.0
• Agree to document all pain medications and associated dosages during participation in the study.
• If taking prescription pain medication, agree to keep dosage constant (unchanged) during participation in the study.
• Agree not to use any topical solution such as analgesic cream or ointment on the treatment area during participation in the study

You may not qualify if…

• Subjects that cannot speak, read or write English
• History or current diagnosis of tendinosis or a tendon tear
• Known neuropathy (nerve damage that affects the treatment area)
• Surgery in the treatment area within the last 6 months
• Non-ambulatory (unable to walk)
• Prisoner
• Pregnant
• Have a pacemaker
• Malignancy in the treatment area
• Refuse to discontinue all other interventional treatment modalities (i.e. transcutaneous electrical nerve stimulation (TENS), electrical stimulation, or other ultrasound therapy) during the study
• Local corticosteroid or platelet-rich plasma (PRP) injection within the past 3 months
• Clinically significant or unstable medical or psychological conditions that would compromise participation in the study
• Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
• Involved in any injury-related litigation in the treatment area
• Open sores or wounds in the treatment area that would prevent use of the device
• Arthritis in the treatment area
• Carpal tunnel syndrome (if subject has elbow tendinitis)

Where it is running

• Clinical Research Consulting — Milford, Connecticut, United States
• Zetroz, Inc — Trumbull, Connecticut, United States

Full record on ClinicalTrials.gov

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