Clinical trial: Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow) (NCT02861183)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female between 18 and 65 years of age

          2. Clinical diagnosis of unilateral lateral epicondylosis defined as:

               1. Pain reproducible on palpation of the lateral epicondyle / common extensor
                  origin; and

               2. Pain reproducible during resisted wrist extension

          3. Subject is symptomatic for at least 6 weeks

          4. Subject has pain in the index lateral epicondyle after grip strength testing that
             measures ≥ 40 mm on a 100 mm VAS

          5. Subject must be willing to abstain from other pharmacological and surgical treatments
             of the index elbow for the duration of the study

          6. Subject is willing to discontinue all systemic and/or topical analgesics including
             NSAIDs, (except the rescue medication oral acetaminophen/paracetamol), for the
             treatment of lateral epicondylosis at least seven days before the initial treatment
             injection and through the completion of the study

          7. If pain medication is needed during the study, subject is willing to use only
             acetaminophen/paracetamol (up to a maximum of 3.0 grams per day per the package
             insert) for the treatment of elbow pain for the duration of the study

          8. At least twenty four hours prior to the Baseline Visit and each follow-up visit, the
             subject must discontinue use of acetaminophen/paracetamol, if used

          9. Subject is able to understand and comply with the requirements of the study and
             voluntarily provides consent

        Exclusion Criteria:

          1. Subjects with a history of hypersensitivity to any of the ingredients in the
             hyaluronan or an inability to tolerate acetaminophen/paracetamol

          2. Subjects in which the investigator believes the anatomical landmarks for injection are
             unable to be adequately identified

          3. Subjects who have a history of surgery to the intra-articular joint of the index elbow
             and/or history of index elbow dislocation

          4. Any diagnosed pathology or trauma that causes pain or symptoms in the index elbow
             other than lateral epicondylosis (e.g. intra-articular pathology, ligament injury,
             cervical radiculopathy, radial tunnel syndrome, osteochondral radiocapitellar lesion
             or posterolateral elbow plica, pain starting after a motor vehicle accident)

          5. Hyaluronic acid injections in the index elbow within the last 6 months

          6. Steroid injections in the index elbow within the last 3 months

          7. Infections or skin diseases in the area of the injection site or elbow joint

          8. Known inflammatory or autoimmune disorders, or other pre-existing medical conditions
             that, in the opinion of the investigator, could impact healing or affect the ability
             of the subject to complete the study and comply with the study requirements

          9. Subject is taking medications at the time of consent which could interfere with the
             treatment procedure, healing and/or assessments. This includes but is not limited to
             oral or injectable anticoagulant treatments, anti-aggregant platelet treatment and
             opioid analgesics. Low dose aspirin (81 mg) used for cardiovascular protection is
             allowed if a stable regimen is maintained for the duration of the study.

         10. Subject is receiving or in litigation for worker's compensation

         11. Subject is a woman who is pregnant or breastfeeding at the screening visit or a woman
             of child bearing potential who refuses to use effective contraception during the
             course of the study

         12. Subject was involved in any other research study involving an investigational product,
             or a new application of an approved product, within 60 days of signing the Informed
             Consent Form (ICF)
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