Comparison Between Platelet Rich Plasma and Corticosteroids for the Treatment of Rotator Cuff Tendinopathy Randomized Controlled Double Blind Clinical Trial
Phase: NA
Conditions: Shoulder Tendinopaty
Sponsor: Hospital Italiano de Buenos Aires

Version October 10, 2023
Comparison
between
Platelet
Rich
Plasma
and
Corticosteroids
for
the
Treatment
of
Rotator
Cuff
Tendinopathy
Randomized Controlled Double Blind Clinical Trial
IRB number: 5269
1

Index
Introduction............................3
Hypothesis .............................7
Goals ......................................7
Primary objective .................7
Secondary objective ............7
Materials and methods ...........9
Design ...................................9
Scope ....................................9
Masking-intervention…..…….9
Population .............................11
Selection criteria ....................11
Inclusion criteria .....................11
Exclusion criteria ....................11
Preparation of thePRP………..12
Variables to be measured and documentation of the
data............................................12
Statistic analysis.......................17
Sample size ...............................17
Randomization ..........................18
Ethical considerations ................18
Damage or complications ...........19
References .................................20
Attachments .................................24
Annex 1: Informed consent. (separate sheet)
Annex 2: ASES Score
Annex 3: Constant Score
Appendix 4 : Pittsburgh Sleep Quality Index.
Annex 5: Insurance for clinical trial
2

Introduction
Rotator cuff tendinopathy represents the most common pathology of the shoulder, and
is the main reason for outpatient consultation for pathologies related to the shoulder
girdle.1,2 First-line treatment for rotator cuff tendinopathy usually consists of activity
modification,
stretching
and
strengthening
exercises,
oral
anti-inflammatory
medications.3-6 When these initial measures are not effective, a second line of
treatment
consists
of
local
infiltrations
with
corticosteroids.3-6
Corticosteroid
injections are often used as an inexpensive and effective treatment to reduce pain and
improve movement. However, most of the studies evaluating the effectiveness of
corticosteroids in patients with rotator cuff tendinopathy show that the clinical results
are usually short-lived.6-7 In addition, corticosteroids do not have any biological effect
that helps to regenerate or reverse the structural changes that occur in the rotator cuff
tendons as a consequence of chronic inflammation. 6-7
In this sense, platelet-rich plasma (PRP) emerges as a promising alternative due to its
ability to release pro-regenerative growth factors (FsC) and cytokines at the lesion site
(cite).8-9 Platelet Rich Plasma is considered a minimal handling product. It is
commonly used in the United States, Europe and all of America. According to the
FDA it falls within the scope of section 361 (Public Health Service Law, Code 21 of
Federal Regulation 1271) of minimally manipulated therapies and according to
ANMAT under law 16463 and decree 9763/64. In addition, the centrifuge that will be
used in the following study at the Hospital Italiano de Buenos Aires is approved by
the ANMAT in (RegenLab disposition 13735). Specifically, at the Hospital Italiano de
Buenos Aires (HIBA), platelet-rich plasma has been used for more than 10 years for
different musculoskeletal conditions, both on an outpatient basis or as an adjuvant to
3

different surgical procedures. Its use is framed within Rule 789; code 5851121. The
main indications for which PRP is used in the HIBA orthopedic service and for which
favorable results have been published are: muscle tears, diabetic foot ulcers, knee and
hip osteoarthritis, osteochondral knee lesions, partial lesions of the anterior cruciate
ligament, glenohumeral osteoarthritis and rotator cuff pathology.8-12
FsCs released by platelets have been shown to perform pro-regenerative functions in
vitro, including promoting stem and progenitor cell proliferation and recruitment, as
well
as
modulating inflammatory responses and stimulating angiogenesis.13-15
Furthermore, FsCs released by platelets have been shown not only to increase the
proliferation of rotator cuff-derived tenocytes but also to promote the production of
key extracellular matrix proteins, including collagen types I, II, and X; decorin;
aggrecan; and biglycan.14 In addition, PRP is also known to offer protection against
oxidative stress, which prevents cell apoptosis after injury, and also inhibits the
inflammatory effects of interleukin-1b (IL1b), which can lead to cuff tendon
degeneration. rotator.15
Several small cohort studies and randomized controlled trials have examined the
clinical benefit of PRP for treating patients with rotator cuff tendinopathy, however
their results have been confounded by small patient samples, lack of a control group,
variable or insufficient data from the PRP preparations and short-term follow-up.16
clinical trials using
Different autologous PRP formulations to treat patients with rotator cuff tendinopathy
have yielded controversial results.16 Recently, Hurley et al.16 performed a systematic
review of randomized controlled trials on the use of PRP for the non-surgical
4

treatment of rotator cuff disease. Five randomized controlled trials met the inclusion
criteria, with 108 patients treated with PRP and 106 treated with a control. Two
studies found that PRP produced better outcomes, mainly pain scores, compared to a
control. One study showed no difference in clinical outcomes and two other studies
reported that PRP alone produced inferior results to control groups.16. Controlled trials
were needed to further investigate the benefits of PRP in early rotator cuff disease.16
Finally, regarding the safety of platelet-rich plasma, it has been shown to be a safe
product in multiple clinical trials. A recent Chocrane meta-analysis evaluated the
adverse effects and complications of PRP in 19 clinical trials (1088 patients).17 This
study included patients who had undergone surgery for multiple orthopedic conditions
including rotator cuff tears, anterior cruciate ligament tears, Achilles and patellar
tendinopathy, and epicondylitis. The percentage of complications associated with
treatment was 1.1% (12/1088 patients). In 15 of the 19 clinical trials there were no
adverse effects or complications related to PRP. Reported complications were
generally mild, including injection site hyperesthesia, local edema, and superficial
injection site infections. No severe complications associated with the procedure were
reported in any of the 1088 patients.17
The purpose of this study is to perform a double-blind randomized controlled trial,
comparing PRP with corticosteroids to provide pain relief and improve function in
patients with rotator cuff tendinopathy. The hypothesis of this study is that PRP would
provide improved pain relief and function in patients with rotator cuff tendinopathy
compared to standard treatment of CS injections.
5

6

Hypothesis
In patients with rotator cuff tendinopathy, PRP subacromial injections produce
significantly greater improvement in shoulder pain and function than standard
treatment with corticosteroid subacromial injection.
Goals
primary objective
To evaluate in patients with rotator cuff tendinopathy whether a subacromial
infiltration with PRP produces a significant improvement in pain (measured through
the visual analogue scale (VAS) for pain) compared to a control group treated with
standard corticosteroid therapy.
secondary objective
2. To assess whether the use of PRP applied as a subacromial infiltration in patients
with rotator cuff tendinopathy improves the functional results (measured using the
American Shoulder and Elbow Surgeons (ASES) score) 18 and Constant's score,19
compared
to
a
control
group
that
underwent
subacromial
infiltration
with
corticosteroids.
3. To assess whether the use of PRP applied as a subacromial infiltration in patients
with rotator cuff tendinopathy improves the sleep disorders (measured using the
Pittsburgh score)
20 compared to a control group that underwent subacromial
infiltration with corticosteroids.
7

4. Confirm that platelet-rich plasma is a proceduresafe through the systematic
recording of adverse effects and complications associated with its use.
Materials and methods
Design
Randomized controlled clinical trial, with intervention group and control group, usual
treatment, blind for the treatment received by the patient and for clinical and
radiological evaluation.
Scope
The entire study will be carried out at the Hospital Italiano de Buenos Aires
headquarters.
Schedule - masking - intervention
Stage 1: All patients with rotator cuff tendinopathy, clinically diagnosed and
confirmed by MRI, will be invited to participate in this study.
After confirming that the patient meets the inclusion criteria, the study will be
explained in detail through the informed consent process (See Consent Annex 1).
Stage 2: Once the patient agrees to participate and has signed the informed consent,
they will be randomized (see randomization).
To the patients of group 1: (control) a subacromial infiltration with corticosteroids
(betamethasone 2 mg) will be performed under ultrasound control.
To the patients of group 2: (Intervention) a subacromial infiltration with PRP will be
performed under ultrasound control.
The week prior to the infiltration, all patients will undergo a prior ultrasound to
confirm rotator cuff tendinopathy and rule out associated supraspinatus ruptures.
8

Masking of patients:
At the time of blood collection, patients will be placed in a hemotherapy extraction
chair with a screen that will prevent the patient from seeing their arm at the time of
blood collection. All patients will have a local anesthetic (cutaneous lidocaine) placed
in the crease of the elbow at the extraction site. The patients in the intervention group
will be injected with the extraction needle and 20 ml of blood will be obtained for the
preparation of the PRP.
On the other hand, the patients in the control group (corticosteroid) will be given
anesthetic and a dermal micro-puncture will be performed with the vacutainer
simulating blood extraction. After this, they will wait 1 minute, simulating the time it
takes for the extraction bag to fill with 20 ml.
In this way, we will ensure the masking of the treatment received, an essential
condition in this type of study since the scores used and validated for the clinical
evaluation of this pathology have a subjective component that could be altered or
biased if the patient knows which treatment received. On the other hand, the control
group, although it has active masking, only consists of a skin micropuncture with a
previous local anesthetic, which does not present complications or adverse effects and
may not be perceived by the patient due to the local anesthesia.
Both procedures will be carried out under antiseptic conditions by a Hemotherapy
technician in the procedure room of the Hemotherapy Service.
Subsequently, the patients will be accompanied to the procedure room where the
assigned treatment will be applied under ultrasound control by the principal
investigator. For patients in the CS group, 1 vial of 2 ml of Betamethasone will be
9

applied. The injection will be performed through a posterolateral approach. The CS
will infiltrate the subacromial bursa. For patients in the PRP group, a volume of 5 ml
will also be injected through a posterolateral approach. Patients will be informed
about possible adverse reactions to both injections. Patients will be allowed to
continue activity as tolerated after the injection and each patient will receive a specific
exercise program to do at home. Patients will not know what treatment they received,
meaning they will be blinded to the intervention. For this, at the time of injection, the
syringe will be covered with black insulating tape so that the patient cannot see the
contents of the syringe.
stage 3: Once the intervention is finished, all the patients will be rehabilitated by the
shoulder team of the rehabilitation center of the Italian Hospital of Buenos Aires. The
rehabilitation protocol will be the one recommended by the American Shoulder and
Elbow Society (ASES).21which is commonly used in the hospital.
Stage 4: During the development of the rehabilitation protocol, the evolution of the
patient will be objectively evaluated with the analogous visual scale, the ASES score,
the Constant score and the Pittsburgh score.(Annex 3 -4 and 5) one month, 3 and 6
months post-infiltration. The physician in charge of the objective evaluation and
documentation of the patient's scores will be the shoulder improvement fellow who
will be blind to the intervention received by the patient.
10

Population
1.
Adults between 18 and 50 years with rotator cuff tendinopathy.
Selection criteria
Inclusion criteria
1. Adults between 18 and 50 years old with rotator cuff tendinopathy defined as
clinically compatible and confirmed by ultrasound.
2. At least 3 months of failed conservative treatment (decreased activity,
anti-inflammatories, kinesiology for at least 3 months before diagnosis).
Exclusion criteria
1. Refusal to participate or informed consent,
2. previous shoulder surgery,
3. Partial or total tears of the rotator cuff,
4. Patients with shoulder osteoarthritis > 2 according to the Samilson and Prieto
classification
5. Advanced fatty infiltration of the rotator cuff muscles (STAGE 3 or 4
according to Goutallier)32
6. Systemic or rheumatoid arthritis,
7. uncontrolled diabetes,
8. Acute or chronic infections of the shoulder to be operated on
9. Ongoing cancer chemotherapy therapies
10. Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
11. Patients with autoimmune diseases;
12. pregnant,
11

Eligible patients will be enrolled in the study by giving their informed consent.
Preparation of platelet-rich plasma
For the PRP group, a leukocyte-poor preparation from a prepackaged kit (RegenLab,
Lausanne, Switzerland) will be used. According to the manufacturer's manual, 10 ml
of venous blood will be drawn into a blood collection tube containing a sodium citrate
anticoagulant and a proprietary separating gel (thixotropic gel) to isolate the red and
white blood cells from the PRP. Samples will be centrifuged at 1500g for 5 minutes to
produce
approximately
7
mL
of
80%
platelets
at
1.6x concentration. The
manufacturer reports a filtration of 99.7%, 87 to 89%, 70 to 75%, and 96.5% of red
blood cells, white blood cells, mononuclear cells, and granulocytes, respectively. The
supernatant is then resuspended by inverting the tube several times and withdrawn
into a separate 5 mL syringe for subacromial injection.
This procedure will be performed 2 times in each patient. The product from the first
kit will be injected into the patient. Instead, the product from the second kit will be
used to evaluate the final composition of the PRP. These specific measurements will
include: the final average of platelets, leukocytes and erythrocytes, and the specific
formula of leukocytes and growth factors. This will allow us to establish a correlation
between the specific composition of the PRP and the functional results of the patient.
Variables to be measured and data documentation
All the variables to be measured will be recorded in a RedCap database specially
designed for this clinical trial.
A) Demographic and related to the injury.
They will be recorded by the principal investigator 24-48 hours prior to the
infiltration.
12

●
Sex: male - female
●
Age: Age in years on the day of infiltration
●
Smoking: yes-no
B) Cynic variables
Pre-infiltration evaluation: It will be in charge of the principal investigator and it
will be carried out 24-48 hours before the infiltration in the orthopedics office.
In it will be evaluated:
clinical variables: Mobility - Pain - Functional Scores (ASES - Constant) - Sleep
disorders (Pittburgh Score)
Imaging variables: Chronic tendinopathy will be defined as the presence of a
hyperintense signal in the supraspinatus on magnetic resonance imaging (carried out a
maximum of 6 months prior to clinical diagnosis), with the absence of partial or total
ruptures of the tendon or as the presence of a hyperechoic signal in the supraspinatus.
supraspinatus with increased intratendon Doppler flow. The presence of the
tendinopathy will be confirmed by ultrasound the week prior to the infiltration to rule
out the progression of the tendinopathy to a partial rupture of the tendon and to
evaluate the presence of flow within the supraspinatus as a sign of tendinopathy with
echodoppler.
Post-infiltration evaluation:
In it will be evaluated:
clinical variables: Mobility - Pain - Functional Scores (ASES - Constant) - (Pittburgh
Score) at one month, 3 months and 6 months postinfiltration. It will be in charge of
the Shoulder Fellow who will not know to which branch of treatment the patient was
assigned. That is to say it will beblinded to intervention.
13

Imaging variables: The presence of vascular flow within the tendon will be measured
in the musculoskeletal ultrasound 6 months after the infiltration in the usual way. It
will be in charge of a doctor specialized in musculoskeletal ultrasound who does not
will know to which treatment arm the patient was assigned. That is to say it will
beblinded to intervention.
The variables that will be evaluated are described below:
●
Mobility:The 4 mobility parameters will be measured in degrees with a
goniometer
-Anterior flexion
-Abduction
-External Rotation with the arm at 900of abduction
-Internal Rotation with the arm at 900of abduction
●
Pain: The visual analogue scale (VAS) will be used to assess the level of pain during
activities of daily living. 0 will be considered as "absence of pain" and 10 as "the
worst pain of your life".
●
General function of the shoulder:The ASES (American Shoulder and Elbow
Surgeons) score will be used.15 (Annex 2) and Constant's score16 (Annex 3) Both
scores evaluate the general functionality of the shoulder in different activities of daily
living, the global mobility of the shoulder, and pain with usual tasks. They are scores
ranging from 0 to 100. Both scores are validated and are the reference scores for
clinical research on rotator cuff pathology.15,16
●
Sleep disorders:The Pittsburgh score will be used.20(Annex 4)
14

c) Imaging variables
●
Magnetic resonance imaging (MRI) of the affected shoulder:
The preinfiltration MRI will measure the presence of pathological hyperintensity
in the supraspinatus, in the absence of partial or total tears of the rotator cuff.
The resonance must have been performed a maximum of 6 months prior to the clinical
diagnosis of the tendinopathy. Otherwise it will be repeated.
Ultrasound 1 week before infiltration and 6 months after infiltration:
The shoulder musculoskeletal ultrasound that will be performed on all patients 1
week before infiltration will confirm the diagnosis of cuff tendinopathy and the
absence of partial or total cuff tears. In addition, an echodoppler will be performed
to
determine
the presence of intratendinous flow as a manifestation of
tendinopathy. In the post-infiltration control musculoskeletal ultrasound 3 months
after the infiltration, tendon healing will be evaluated, which will be defined as the
absence of intratendinous vascular flow. Both MRI and ultrasound are part of the
study and routine follow-up of patients treated for rotator cuff tendinopathy.
d) Variables related to security
Adverse effects and immediate post-infiltration complications, one month, 3 months
and 6 months post-infiltration will be recorded.
In the event that the patient presents a complication, they will have the contact
number of the principal investigator to be attended by him or by a surgeon from the
team in the orthopedic clinics or on duty at the Italian Hospital of Buenos Aires.
Likewise, the doctors on duty will be informed about the development of the
following protocol in order to notify the principal investigator or a member of the
team in the event that a patient presents any post-infiltration complication.
15

Scheme of the evaluation points in time, responsible for the evaluation and the
variables that will be recorded
pre-infiltration
(24-48 hours
prior)
1 month
post-infiltration
3 months
post-infiltration
6 months
post-infiltration
Evaluator
Principal
investigator
Shoulder Fellow
Shoulder Fellow
(clinical variables)
Sonographer (imaging
variables)
Shoulder Fellow
(clinical variables)
Variables
Clinics
-Demographic
-Mobility
-Pain
-Functional
Scores (ASES –
Constant -
Pittsburgh)
-Mobility
-Pain
-Functional
Scores (ASES –
Constant-Pittsbu
rgh)
-complications
-Mobility
-Pain
-Functional Scores
(ASES –
Constant-Pittsburgh)
-complications
-Mobility
-Pain
-Functional Scores
(ASES –
Constant-Pittsburg
h)
-complications
Imaging
variables
Magnetic
nuclear
resonance
Ecodoppler
musculoesquel
ético
Ecodoppler
musculoesquelético
16

Statistical analysis raised
Quantitative variables will be presented as mean and standard deviation or median
and interquartile interval according to the observed distribution. Categorical variables
will be presented as proportions. The 95% confidence intervals will be calculated for
each of the estimators.
The comparison of continuous data between two groups will be analyzed with the t
test if the distribution of the variables is normal or with the Mann-Withney-Wilcoxon
test if it is not. The analysis of categorical data will be carried out with the chi-square
test. Statistical analysis will be performed with STATA MP version 16 (Stata
Corporation, College Station, TX). A p value less than 0.05 will be considered
statistically significant.
Sample size
To calculate the sample size, the expected values ​of the variable "pain" represented by
the VAS, which is the main outcome variable, are used. The minimal clinically
relevant difference (MCID) was previously described in the setting of rotator cuff
disease as 1.5 points with a standard deviation of 2.41 points on a 10-point scale for
shoulder pain.22 We will work with a type I error probability of 5% and a power of
90%. Using these parameters in a superiority formula, a sample size of 45 patients per
group was calculated. Considering the possibility of a loss to follow-up of 10% of the
patients per group, 50 patients per group will be included, with a total final sample of
100 patients. The sample size was calculated using the formula of Fleiss et al.23
17

Randomization
All included patients will be randomized after obtaining informed consent. Each
patient will be randomly assigned a treatment arm using the online randomizer
(http://protocolos.hospitalitaliano.org.ar)
to
treatment
arms
1
(control)
or
2
(intervention)
ethical considerations
Participation in the study will be in all cases voluntary and certified by the informed
consent process. The study will be carried out in full accordance with current national
and international regulations: Declaration of Helsinki of the World Medical
Association, Provision 6677/10 of ANMAT, and the Standards of Good Clinical
Practices ICH E6.
The proposed intervention does not frequently present adverse events and there are
known contraindications for its application. The procedure will be paid for by the
financing of the study, it will not imply any cost to the patient or their health
coverage. The costs of monitoring and periodic evaluations will be borne by the study
investigators.
All study data will be treated with the utmost confidentiality, with restricted access
only to authorized personnel for the purposes of the study in accordance with current
legal regulations National Law on Protection of Personal Data 25,326 (Habeas Data
Law.
18

Damage or complications
The coverage for the risk of Institutional Malpractice is attached, of the Clinical Trial
that will be contracted to carry out the following study once approved by the Ethics
Committee.(Annex 5) In the same Coverage is granted to the claim or claims that
occur due to any injury, illness or death of Patients, caused or alleged to have been
caused, by: The administration of medicinal products indicated in the Investigation
Protocol, By acts of Medical Praxis committed during the execution of the Clinical
Trial (negligence, incompetence, imprudence and non-observance of duties). In this
multidisciplinary work, 2 Orthopedics and Hemotherapy services will be included.
Each service will be responsible for the costs of interventions free of charge and with
overtime.
In the case of the preparation of the PRP, they will be carried out free of charge by a
Hemotherapy service plant doctor.
The infiltrations will be carried out by a doctor of the Shoulder Pathology team of the
Orthopedics and Traumatology Service of the Italian Hospital of Buenos Aires
The rehabilitation will be carried out with the standard HIBA kinesiology protocol for
patients with chronic rotator cuff tendinopathy and will be carried out by the
rehabilitation team of the HIBA Kinesiology service.
19

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