Clinical trial: Efficacy of Injection Therapy for Lateral Epicondylosis (NCT01476605)

Eligibility criteria:
Inclusion Criteria:

          1. age 18-65 years

          2. diagnosis of CLE, confirmed by the PI using clinical symptoms and exam findings of
             tenderness over the lateral epicondyle and/or extensor tendon, and pain on 2 extensor
             muscle provocation tests

          3. self-reported CLE-related pain for at least 6 months

          4. self-reported failure of at least 2 of the 3 most common treatments for CLE (a course
             of NSAIDS, physical therapy or corticosteroid injections).

        Exclusion Criteria:

          1. current bilateral CLE

          2. a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE

          3. current carpal tunnel syndrome, other elbow pathology, or acute trauma of the
             CLE-affected upper extremity

          4. self-reported history of bleeding disorders, other hematologic conditions,
             inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or
             neuropathy

          5. current use of opioids for pain

          6. anticoagulation or immunosuppressive therapy in the prior month

          7. intent to use NSAIDs or steroids

          8. known allergy to dextrose, acetaminophen or lidocaine

          9. MRI contraindications: non-compatible metal in the CLE-affected upper extremity or
             severe claustrophobia

         10. unresolved litigation

         11. self-reported pregnancy. Pregnant women are excluded from the study because pregnancy
             changes the characteristics of connective tissue including ligaments and tendons
             associated with CLE and, so, is an unacceptable confounder in this pilot level study.
             There is no report however, about dextrose, morrhuate sodium or PrT being harmful to
             pregnant women. Therefore we will not draw confirmatory labs to ensure that women of
             childbearing age are not pregnant. Rather we will accept self-report on pregnancy
             status at the time of consent. If a woman becomes pregnant during the study she will
             be dropped from the study.
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