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.
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:
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