Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
With
CTM vs. Steroid is a double-blind randomized controlled trial. Patients will be randomized to CTM Boost or Kenalog-40 (corticosteroid). Patients will be followed for six months and have three follow-up visits where they will have a physical exam, complete questionnaires, have a physical exam, including physical functional assessments, be screened for adverse events. Data will be collected from their medical chart after each visit. CTM Boost (CTM Biomedical, Miami, FL) is a tissue allograft derived from decellularized, particulate human placental connective tissue. It is regulated as a minimally-manipulated human cell, tissue, and cellular and tissue-based product (HCT/P) biologic by the FDA and is marketed for homologous use to supplement or replace damaged or inadequate connective tissue. It is implanted via injection into the tissue. CTM Boost is available in a range of volumes. In this study, the 2.0cc volume of CTM Boost will be administered by injection directly into the subacromial space using a 20G needle. Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of kenalog-40 will be administered directly into the subacromial space using a 20G needle (for patients randomized to this control arm). Study Questionnaires are as follows: * WORC: The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff. * SANE: The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline. SANE scores are most commonly used by orthopedic sports specialist surgeons, and usually for the shoulder and the knee. * VAS: The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be). * ASES: The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function * Functional Assessments: various arm/shoulder exercises with dumbbells, weights or resistance. Time until patient is fatigued and/or number of repetitions will be measured. * These tests will include the following: * Empty can exercise with dumbbell resistance: Arm held in a position with weighted resistance, while measuring number of seconds to fatigue (or unable to maintain arm at 90 degrees). * Side-lying external rotation with dumbbell resistance: Lie on side (opposite shoulder) with weight held in hand, elbow flexed to 90 degrees while rotate through a full range of motion at the shoulder. The number of repetitions during a 30-second period are recorded. Full can exercise with dumbbell resistance: Stand parallel to wall with the handheld in a fist and shoulder forward flexed parallel to the floor. A measuring stick will be used to measure how far forward on the yardstick patient can reach. The number of repetitions during a 60-second period are recorded. External rotation of shoulder at 0 and 90 degrees with Thera-Band resistance. Patient will be instructed to perform rapid swinging motions in a 30-degree arc until fatigued. Safety Evaluation: * Infection * Tear of the tendon * Shoulder stiffness * Admission to the hospital for a shoulder-related issue * Surgical rotator cuff repair or subacromial decompression. Data collected from a medical record review: MRN Age Gender Weight Height Comorbidities Duration of symptoms Smoking status Diabetes Shoulder imaging reports from pre-enrollment MRI/xray Progress/Office notes Concomitant Medication
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
