Clinical trial: Long Duration Therapeutic Ultrasound for Tendon Healing (NCT02466308)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 17-year-old male comes to the office due to several months of right elbow pain.  The pain is worse with activity and limits his workouts and activities.  He has tried over-the-counter medications with limited relief.  Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment.  He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy.

Patient description (patient's own words): I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already.

Does the patient match the trial criteria? Contradiction