Clinical trial: Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis (NCT01921569)

Eligibility criteria:
Inclusion Criteria:

          -  At least 18 years old.

          -  Medicare patients may be selected.

          -  Both male and female patients will be selected.

          -  A negative x-ray of the elbow

          -  Diagnosis of lateral epicondylitis by history and exam with symptoms for no longer
             than one year.

          -  Females of childbearing potential must be willing to use acceptable methods of
             contraception (birth control pills, barriers, or abstinence).

          -  Patient understands and is willing to participate in the clinical study and can comply
             with weekly visits and the follow-up regimen.

          -  Patient has read and signed the IRB/IEC approved Informed Consent Form before
             screening procedures are undertaken.

        Exclusion Criteria:

          -  Prior surgery at the site

          -  Site exhibits clinical signs and symptoms of infection.

          -  History of chronic soft tissue inflammation of more than 6 months.

          -  A positive X-ray for fracture or significant anatomic abnormality including fracture,
             advanced arthritis, excessive calcification, etc.

          -  No history of corticosteroid injection within the past 30 days.

          -  Joint instability

          -  No rheumatologic conditions involving the elbow.

          -  No evidence of significant neurological entrapment or neurological disease of the
             forearm

          -  Concurrent cervical radiculopathy

          -  The presence of comorbidities that can be confused with or can exacerbate the
             condition including:

               -  Previous elbow trauma

               -  Previous elbow surgery

          -  Patients with a history of more than two weeks treatment with immuno-suppressants
             (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to
             initial screening, or who receive such medications during the screening period, or who
             are anticipated to require such medications during the course of the study. (i.e. a
             one month "washout period" for these drugs.)

          -  Patients on any investigational drug(s) or therapeutic device(s) within 30 days
             preceding screening.

          -  History of radiation at the site.

          -  Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.

          -  Patients who are unable to understand the aims and objectives of the trial.

          -  Presence of any condition(s) which seriously compromises the subject's ability to
             complete this study, or has a known history of poor adherence with medical treatment.

          -  Pregnant or breast feeding. No pregnancy within the past 6 months.
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.


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