Overall Design [Prospective randomized double-blind study for the clinical effect of combined
ESWT and platelet-rich plasma (PRP) or PRP or ESWT alone or sham treatment on patients with
shoulder rotator cuff lesions and without complete tear.]
The participants will be separated into 4 groups according to computer statistical
randomization.
The investigators shall use STORZ MEDICAL Extracorporeal Shock Wave Therapy 3000 impulse 24KV
(0.32mJ/mm2) Focus at two points (3000 impulse each point) near the insertion of
supraspinatus and rotation interval of the involved shoulder.
PRP: The PRP form Regen Kit BCT 1 Platelet Rich Plasma PRP will be used and will be injected
into the Subacromial bursa (Hyajoint injection as a control)
HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5
mL per syringe
The randomized, double-blind, placebo-controlled clinical study will involve 30-50 patients
who have rotator cuff lesions without complete tear. The inclusion criteria are (1) patients
who have pain around the shoulder, a positive impingement sign, and a positive imaging
diagnosis of rotator cuff pathology without complete tear; (2) patients who do not respond to
conservative therapy or rehabilitation for at least 3 months; and (3) patients age between 35
and 80 years, who sign the informed consent form. The investigators will exclude patients who
have rheumatic diseases, glenohumeral osteoarthritis, full-thickness cuff tears, fractures,
infections, or tumors; those who have received a subacromial injection within 3 weeks; and
those who are pregnant or want to become pregnant; and those who have arrhythmia, pacemaker,
coagulopathy, or malignancy.
The intent-to-treat population is a fully randomized group of patients who have a baseline
value (Constant score and VAS before treatment). The imaging diagnosis of a rotator cuff
lesion is made by a musculoskeletal radiologist who has considerable experience in
interpreting magnetic resonance imaging (MRI) results for shoulders. On MRI, rotator cuff
tendinosis is characterized by increased in tratendinous signal intensity onT2-weighted
images without tendon disruption. The tendinosis of the MRI imaging was further diverted into
three grades. Grade 1 indicates less than 1/3 of the supraspinatus tendon is involved, Grade
2 indicates 1/3 to 2/3 and Grade 3 indicates more than 2/3 of the supraspinatus tendon is
involved. Partial-thickness tearing is characterized by the presence of focal hyperintense
fluid or a fluid-like signal intensity that extended into the tendon on the T2-weighted
images. A full thickness tear is diagnosed by the extension of hyperintense fluid or
fluid-like signal intensity through the entire thickness of the interrupted rotator cuff
tendon on T2-weighted images.
Every participant will have Subacromial injection of 2.5 ml PRP or HA (control) one week
before ESWT or sham therapy. In Group I, patients receive 3000 impulses of shockwaves at 24kV
(energy flux density, 0.32mJ/mm2) to the affected shoulder as a 1-time treatment. Treatments
are performed on an outpatient basis. The area of treatment (2 points near the supraspinatus
insertion and rotator interval) is focused with a control guide on the machine, and surgical
lubricant is placed on the skin in contact with the shockwave tube with the patient in a
supine position. The sham treatment entail use of the device in which the silicone pad was
removed from the stand-off device, but the participants can still hear the sound of the shock
wave and have tingling sensation over the skin but without energy transduced. The
participants' vital signs and local discomfort are monitored throughout the course of
treatment. The treated area is inspected for local swelling, ecchymosis, or hematoma
immediately after the treatment.
The participants will have a pain medication-free interval 3 days prior to each evaluation.
After treatment and during follow-up, participants will be restricted to the use of a 750mg
of acetaminophen per day for pain, in order to facilitate usage and comparison of the
medications among the patients. Follow-up examinations are performed independently by one of
the coauthors, who is blinded to patient treatment status at 1week, 2week, 1month, 3 months,
6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected one week
and 1 month after treatment and shoulder MRI will be checked 12 months after treatment. The
participants who have persistent shoulder discomfort may be advised to undergo surgical
intervention.