Clinical trial NCT03232749
Conditions: Osteoarthritis of the Glenohumeral Joint
Sponsor: University of Florida
Start date: 2018-04-18; Completion date: 2019-06-06
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.

Detailed description:
The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.

Arms: arm 1: Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder
Interventions: intervention 1: intraarticular corticosteroid injections (IACSI) intervention 2: corticosteroid injections intervention 3: Ultrasound
Intervention descriptions: intervention 1: ultrasound-guided IACSI will be administered intervention 2: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder intervention 3: ultrasound-guided IACSI

Protocol documents:
Prot_SAP_000.pdf: 
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Protocol 
1. Project Title: 
Predicting Response to Intra-Articular Corticosteroid Injection in Patients with Osteoarthritis 
of the Glenohumeral Joint 
 
2. Investigators: 
 
PI:   
Bradley Schoch, M.D. 
Co-I:  
Daniel Herman, M.D. 
Jason Zaremski, M.D.  
M. Seth Smith, M.D. 
Bryan Prine, M.D. 
Thomas Wright, M.D. 
Kevin Vincent, M.D. 
Heather Vincent, Ph.D. 
Kevin Farmer, M.D. 
Michael Moser, M.D. 
Joseph King, M.D. 
 
3. Abstract 
In 2009, the AAOS made formal recommendations for osteoarthritis of the glenohumeral 
joint, but was unable to formally recommend physical therapy, pharmacotherapy or 
corticosteroid injection.  Despite a lack of clinical evidence, orthopedic surgeons continue to 
recommend conservative treatments prior to considering surgical intervention for primary 
osteoarthritis of the glenohumeral joint.  Generally, activity modification, over the counter 
analgesics, and intraarticular corticosteroid injections (IACSI) are offered prior to considering 
arthroplasty.5,6  The scientific literature remains limited regarding IACSI success for 
glenohumeral arthritis, with practices largely being adopted from the lower extremity 
literature.  There remains only one small study assessing outcomes following IACSI, where 
success was indicated as significant pain reduction, improvement in the Constant-Murley 
scale, Shoulder Pain and Disability Index (SPADI) scores and satisfaction with treatment.3  
The purpose of this study is to assess the effectiveness of IACSI for glenohumeral arthritis 
by 1) measuring clinical and radiographic parameters and 2) identifying predictors of IACSI 
success.  
 
4.  Background and Significance 
Research regarding IACSI for glenohumeral OA is limited.  While many articles have 
assessed the role of hyaluronic injections for this condition, only one study has assessed the 
effectiveness of IACSI. 4,3,7,2  In this study, IACSI was retrospectively compared to intra-
articular hyaluronic acid (HA) injections.3  All injections were administered in an unguided 
fashion.  Corticosteroid dose for each injection was 40 mg of Depomedrol. Both groups 
received three injections one week apart, including the steroid group.  Within the IACSI group, 
pain relief was only found to be significant at one month (6.25 vs 4.4, p=0.04).  The clinical 
significance of this change remains debatable.  This improvement was significant for both pain 
at night, as well as pain with activity.  No significant differences remained at three months or 
six months.  SPADI scores showed no significant changes over time.  The range of motion 


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subscore of the Constant-Murley score remained significantly improved.  They were unable to 
associate the grade of OA to pain relief following IACSI.   
 
This study differs dramatically from clinical practice, where IACSI is normally administered 
as a single injection.  Repeat injections are often delayed, with some surgeons 
recommending a three month break between injections.  Presently, there is an evidence gap 
with respect to evidence of the effectiveness of single-injection IACSI on clinical and patient-
reported outcomes in patients with glenohumeral OA.   
 
5. Specific Aims 
To address this deficit in the literature, there are two specific aims: 
 
1. Assess the effectiveness of IACSI in patients with primary osteoarthritis in the 
shoulder.  This will be determined through three patient-reported outcomes 
measures:   
 
o ASES (American Shoulder & Elbow Surgeon) score improvement > 20.9 points8  
o VAS (Visual Analog Scale) pain score improvement > 1.4 points  
o SST (Simple Shoulder Test) score improvement > 2.4 points 
 
2. Assess clinical and radiographic predictors of success (outlined below) in patients 
who elect to receive IACSI as treatment for primary osteoarthritis in the shoulder.   
o Clinical  
 
Duration of Symptoms 
 
Location of pain (Anatomic Diagram, Figure 1) 
 
Pain diagrams will be analyzed using a computer overlay protocol 
and analyzed in a binary matter according to region. Image 
software (NIH, Bethesda, MD) will be used. Proportions of the 
patients responding to injection in each anatomic region and groups 
of regions will be calculated.  95% confidence intervals will be 
determined.1 
 
History of prior injection  
 
Range of motion (Forward elevation in the scapular plane, ER at 0o 
abduction, IR at 0o abduction) 
 
Standardized pain and function scores (VAS pain, SST, ASES) 
 
Prior analgesia (OTC, Narcotic) 
 
Initial response to anesthetic component (VAS 5-10 min post-injection) 
 
o Radiographic  
 
Joint space narrowing (measured) 
 
Subluxation 
 
Walch classification 
 
Subchondral cysts 
 
Samilson & Prieto Radiological Classification 
 
Mild Arthrosis: inferior humeral and/or glenoid exostosis < 3mm in 
height 


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 
Moderate Arthrosis: inferior humeral and/or glenoid exostosis 
measuring  3mm to 7mm slight gleno-humeral irregularity 
 
Severe Arthrosis: inferior humeral and/or glenoid exostosis 
measuring > 7mm gleno-humeral joint narrowing and sclerosis 
 
6. Research Plan 
 
Subjects: Five hundred patients, both male and female, age 18-100 years, with a diagnosis of 
symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population 
seeking treatment at the Orthopaedics Sports Medicine Institute.  Subjects enrolled into the 
study will be those who have failed previous treatment including over-the-counter analgesics 
and activity modification, and have elected to receive a medically-indicated, ultrasound-guided 
IACSI in the shoulder. Two or three plain film views of the shoulder (including a Grashey and 
axillary lateral) obtained in accordance with standard of care prior to enrollment in the study 
will be reviewed.  Once written informed consent has been obtained, subjects will complete 
the pre-procedural pain chart (Figure 1), ASES, VAS pain (at rest, with activity, at night), and 
SST scores.  Upon completion of all outcomes measures, the ultrasound-guided IACSI (5cc of 
1% lidocaine, 2cc of depomedrol (40mg/mL)) will be administered.  Subjects will be asked to 
repeat the VAS pain score (at rest) 5-10 minutes following administration of the injection to 
assess the response to the anesthetic component of the injection.  Upon conclusion of the 
visit, no clinical follow-up appointment will be scheduled, and subjects will be instructed to 
follow-up with their physician as needed; this is in accordance with standard of care for this 
patient population. 
 
 
(Figure 1: Pre-procedural pain chart, anatomic diagram) 
 
 
Subjects will be contacted via email through the REDCap survey function or a phone call at 
two weeks, one month, two months, three months, and six months following the injection to 
complete the ASES, VAS pain (at rest, with activity, at night), and SST scores. If an email 
survey is not completed in REDCap, a reminder email will be sent every two days, up to two 


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times. If, after the final email reminder, the REDCap survey is still incomplete, a member of 
the study staff will call the subject and complete the survey via telephone call.  
 
 
Exclusion Criteria: Patients will be excluded from the study for any of the following reasons:  
 
Post traumatic osteoarthritis 
 
Inflammatory osteoarthritis 
 
Imaging confirmed rotator cuff tear 
 
Prior ipsilateral shoulder surgery  
 
Memory loss or inability to complete study measures 
 
History of allergy to injection medications 
 
Diabetic patients with patient-reported fasting blood glucose >200   
 
Prior injection in the ipsilateral shoulder within three months 
 
 
Data Collection: The following data points and information will be collected for later analysis:  
 
Patient name 
 
MRN 
 
Gender 
 
Date of birth 
 
E-mail address 
 
Telephone number 
 
Location of pain (pre-procedural pain chart) 
 
Duration of symptoms 
 
History of prior IACSI in ipsilateral shoulder 
 
Prior analgesia 
 
Shoulder Range of Motion (Forward elevation, External rotation, Internal rotation) 
 
Radiographic findings  
 
Date of IACSI 
 
Date of each follow-up survey 
 
Results of each standardized pain and function survey 
 
Confidentiality: Once all enrolled subject data is collected, subject PHI will be removed and the 
data will be maintained by using assigned research identification numbers that uniquely 
identify each individual.  Date of birth will be converted to age, and dates will also be 
converted to time frames.  Coded data will be stored on a secure online database such as 
REDCap and an Excel spreadsheet on a password protected computer within the Department 
of Orthopaedics and Rehabilitation.  Data will be converted to a SPSS file for analysis which 
will also be stored on a secure department server.  Data will be used only in aggregate and no 
identifying characteristics of individuals will be published or presented.  Only the study team 
members will have access to these files.  After the study is completed, local data will be stored 
with other completed research studies in a secured storage room until the appropriate time 
when the research files may be purged according to university policy. 
 
Data Analysis:  
 
Each patient-reported outcome measure will be assessed at each time point pre- and post-
injection and grouped according to the grade of shoulder osteoarthritis.  Groups will be 
compared using a one-way ANOVA analysis.  Groups with a response to injection (VAS score 
improvements greater than the minimal clinically important difference) will be compared to 
those without a significant response.  Single multi-level regression analysis will be performed 
to assess for clinical and radiographic risk factors outlined in Aim Two that may predict 
corticosteroid injection failure.  


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7. Possible Discomforts and Risks 
Subjects may experience the standard discomforts and risks associated with any intraarticular 
injection independent of this study.   
 
Although a minimal risk, completing the study questionnaires may cause stress to some 
participants who may believe that they are not providing correct answers to the research 
team. To reduce this stress, the investigators will reassure subjects that all survey answers 
are based on what they feel, and there is no “correct” answer. 
 
 
 
Follow up surveys will be completed by phone or via email with a secure link to surveys in 
REDCap, thus a loss of confidentiality is a potential risk. 
 
8. Possible Benefits 
There is no direct benefit to patients who take part in this study.  This study may benefit future 
patients by identifying factors to assist providers in predicting a patient’s response to an IACSI. 
 
 
9. Conflict of Interest 
No conflict of interest for this study.  
 
 
10. References 
 
1.  Kennedy DJ, Mattie R, Nguyen Q, Hamilton S, Conrad B. Glenohumeral Joint Pain Referral 
Patterns: A Descriptive Study. Pain Med. Malden Mass. 2015 Aug;16(8):1603–1609. 
doi:10.1111/pme.12797 
2.  Kwon YW, Eisenberg G, Zuckerman JD. Sodium hyaluronate for the treatment of chronic 
shoulder pain associated with glenohumeral osteoarthritis: a multicenter, randomized, 
double-blind, placebo-controlled trial. J. Shoulder Elb. Surg. Am. Shoulder Elb. Surg. Al. 
2013 May;22(5):584–594. doi:10.1016/j.jse.2012.10.040 
3.  Merolla G, Sperling JW, Paladini P, Porcellini G. Efficacy of Hylan G-F 20 versus 6-
methylprednisolone acetate in painful shoulder osteoarthritis: a retrospective controlled trial. 
Musculoskelet. Surg. 2011 Dec;95(3):215–224. doi:10.1007/s12306-011-0138-3 
4.  Noël E, Hardy P, Hagena F-W, Laprelle E, Goebel F, Faure C, et al. Efficacy and safety of 
Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective 
multicenter 
study. 
Jt. 
Bone 
Spine 
Rev. 
Rhum. 
2009 
Dec;76(6):670–673. 
doi:10.1016/j.jbspin.2009.10.008 
5.  Parsons IM, Weldon EJ, Titelman RM, Smith KL. Glenohumeral arthritis and its 
management. 
Phys. 
Med. 
Rehabil. 
Clin. 
N. 
Am. 
2004 
May;15(2):447–474. 
doi:10.1016/j.pmr.2003.12.001 


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6.  Rashid A, Kalson N, Jiwa N, Patel A, Irwin A, Corner T. The effects of pre-operative intra-
articular glenohumeral corticosteroid injection on infective complications after shoulder 
arthroplasty. Shoulder Elb. 2015 Jul;7(3):154–156. doi:10.1177/1758573214557149 
7.  Silverstein E, Leger R, Shea KP. The use of intra-articular hylan G-F 20 in the treatment of 
symptomatic osteoarthritis of the shoulder: a preliminary study. Am. J. Sports Med. 2007 
Jun;35(6):979–985. doi:10.1177/0363546507300256 
8.  Tashjian RZ, Hung M, Keener JD, Bowen RC, McAllister J, Chen W, et al. Determining the 
minimal clinically important difference for the American Shoulder and Elbow Surgeons 
score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder 
arthroplasty. 
J. 
Shoulder 
Elbow 
Surg. 
2017 
Jan;26(1):144–148. 
doi:10.1016/j.jse.2016.06.007 
 

ICF_001.pdf: 
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INFORMED CONSENT FORM
to Participate in Research, and
AUTHORIZATION
to Collect, Use, and Disclose Protected
Health Information (PHI)
INTRODUCTION
Name of person seeking your consent:
Place of employment & position: 
Please read this form which describes the study in some detail. A member of the 
research team will describe this study to you and answer all of your questions.  Your 
participation is entirely voluntary.  If you choose to participate you can change your mind 
at any time and withdraw from the study.  You will not be penalized in any way or lose any 
benefits to which you would otherwise be entitled if you choose not to participate in this 
study or to withdraw.  If you have questions about your rights as a research subject, 
please call the University of Florida Institutional Review Board (IRB) office at (352) 273-
9600.   
GENERAL INFORMATION ABOUT THIS STUDY
1. Name of Participant ("Study Subject")
___________________________________________________________________ 
2.
What is the Title of this research study?
Predicting Response to Intra-Articular Corticosteroid Injection in Patients with 
Osteoarthritis of the Glenohumeral Joint
3. Who do you call if you have questions about this research study?
Principal Investigator:  Bradley Schoch, M.D. at 352-273-7375
Other research staff:   Michelle Bruner, Study Coordinator at 352-273-7337 
Study ID:IRB201700603   Date Approved: 8/2/2017   Expiration Date: 4/26/2020


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IRB Version: 10/19/2011
PI Version: 7/27/2017
INFORMED CONSENT FORM
to Participate in Research, and
AUTHORIZATION
to Collect, Use, and Disclose Protected
Health Information (PHI)
INTRODUCTION
Name of person seeking your consent:
Place of employment & position: 
Please read this form which describes the study in some detail. A member of the 
research team will describe this study to you and answer all of your questions.  Your 
participation is entirely voluntary.  If you choose to participate you can change your mind 
at any time and withdraw from the study.  You will not be penalized in any way or lose any 
benefits to which you would otherwise be entitled if you choose not to participate in this 
study or to withdraw.  If you have questions about your rights as a research subject, 
please call the University of Florida Institutional Review Board (IRB) office at (352) 273-
9600.   
GENERAL INFORMATION ABOUT THIS STUDY
1. Name of Participant ("Study Subject")
___________________________________________________________________ 
2.
What is the Title of this research study?
Predicting Response to Intra-Articular Corticosteroid Injection in Patients with 
Osteoarthritis of the Glenohumeral Joint
3. Who do you call if you have questions about this research study?
Principal Investigator:  Bradley Schoch, M.D. at 352-273-7375
Other research staff:   Michelle Bruner, Study Coordinator at 352-273-7337 
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4.  Who is paying for this research study? 
The sponsor of this study is The University of Florida.
5.  Why is this research study being done? 
The purpose of this research study is to determine how effective a single 
corticosteroid injection is in patients with shoulder arthritis. We are also interested in 
identifying clinical and radiographic (such as x-rays) indicators that could be used to 
help physicians predict how successful a corticosteroid (or cortisone) injection will be 
for patients with shoulder arthritis. 
You are being asked to be in this research study because you are a patient in the 
Department of Orthopaedics and Rehabilitation at University of Florida, age 18-100 
years, with painful shoulder arthritis, and have elected to receive a cortisone injection 
in your shoulder.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. 
 At most, the Web site will include a summary of the results. You can search this Web 
site at any time.
WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY?
6. What will be done as part of your normal clinical care (even if you did not 
participate in this research study)? 
Your shoulder physician may order one or more x-rays of your shoulder, even if you 
recently had other x-rays taken, to make sure they get the best views to properly 
assess the level of arthritis in your shoulder. Your physician has also determined that 
a cortisone injection in one or both of your shoulders may be beneficial to you. This 
procedure, and its benefits and risks, will be described in detail by your physician. 
These x-rays and course of treatment have been recommended regardless of your 
participation in this study.
7.  What will be done only because you are in this research study? 
You will be asked to complete a series of surveys or questionnaires about how your 
shoulder is feeling and functioning, and to let us know of any changes in your medical 
care such as medication changes at six (6) different time points throughout your care: 
to the day of your injection, and 2 weeks, 1 month, 2 months, 3 months, and 6 months 
after your injection. These surveys or questionnaires will take approximately 10-15 
minutes to complete. The follow-up surveys may be completed online through a link 
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sent to you by email or by a telephone call made to you by a member of the study 
staff. 
Information will also be copied from your medical record such as your shoulder pain 
history, previous shoulder injections, range of motion, and information from your 
shoulder x-rays or other radiographic studies (MRI or CT scan). 
If you have any questions now or at any time during the study, please contact one of 
the research team members listed in question 3 of this form.
8. How long will you be in this research study?
You will participate in this research study for 6 months following your cortisone 
injection. 
9. How many people are expected to take part in this research study?
500 subjects will be recruited to participate in this study.
WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND 
WHAT ARE YOUR OPTIONS?
10.What are the possible discomforts and risks from taking part in this research 
study?
You will be receiving a cortisone injection regardless of your participation in this study.  
There are certain discomforts or risks associated with any injection.  If you have any 
questions about these risks, please discuss these with your shoulder physician prior to 
receiving the injection.
Although a minimal risk, completing the study questionnaires may cause stress to 
some participants who may believe that they are not providing correct answers to the 
research team. To reduce this stress, the investigators will reassure you that all 
survey answers are based on what you feel, and there is no “correct” answer.
Researchers will take appropriate steps to protect any information they collect about 
you.  However, there is a slight risk that information about you could be revealed 
inappropriately or accidentally.  Depending on the nature of the information, such a 
release could upset or embarrass you, or possibly affect your insurability or 
employability.  Questions 17-21 in this form discuss what information about you will 
be collected, used, protected, and shared.
This study may include risks that are unknown at this time.
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Participation in more than one research study or project may further increase the 
risks to you.  If you are already enrolled in another research study, please inform 
one of the research team members listed in question 3 of this form or the person 
reviewing this consent with you before enrolling in this or any other research study 
or project.
Throughout the study, the researchers will notify you of new information that may 
become available and might affect your decision to remain in the study. 
If you wish to discuss the information above or any discomforts you may experience, 
please ask questions now or call one of the research team members or listed in 
question 3 of this form.
11a. What are the potential benefits to you for taking part in this research study?
There is no direct benefit to you by participating in this study.
11b. How could others possibly benefit from this study?
This study may benefit future patients by helping physicians identify clinical and 
radiographic (such as x-rays) indicators that could predict how successful a cortisone 
injection will be for patients with shoulder arthritis.
11c. How could the researchers benefit from this study?
In general, presenting research results helps the career of a scientist. Therefore, the 
Principal Investigator listed in question 3 may benefit if the results of this study are 
presented at scientific meetings or in scientific journals.
12.What other choices do you have if you do not want to be in this study? 
You may choose to not participate in this study. You may still receive the cortisone 
injection in your shoulder as previously determined by your physician; however, you 
would not complete the questionnaires before or after the injection. 
If you do not want to take part in this study, tell the member of the research staff that 
is speaking to you about the study and do not sign this Informed Consent Form.
The investigators associated with this project may or may not be involved with your 
medical care before, during, and after this research study.  Your participation in this 
study is voluntary, and any decision to take part or not participate will in no way affect 
any medical care you receive from members of the research team.
If you believe that your participation in this study or your decision to withdraw from or 
to not participate in this study has improperly affected your medical care, you should 
discuss this with the IRB office.
If you have any questions regarding your rights as a research subject, please call the 
Institutional Review Board (IRB) office at (352) 273-9600.
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University of Florida Students:
You have been invited to participate in this research project because you are a student 
with painful shoulder arthritis and have elected to receive a cortisone injection in 
your shoulder.  The investigators associated with this project may or may not teach in 
your college or be associated with courses for which you are enrolled or might be 
expected to register in the future.  Your participation in this study is voluntary and any 
decision to take part or not to participate will in no way affect your grade or class 
standing.
If you believe that your participation in this study or your decision to withdraw from or 
to not participate in this study has improperly affected your grade(s), you should 
discuss this with the dean of your college or you may contact the IRB office.
13a. Can you withdraw from this study?
You are free to withdraw your consent and to stop participating in this study at any 
time.  If you do withdraw your consent, you will not be penalized in any way and you 
will not lose any benefits to which you are entitled.
If you decide to withdraw your consent to participate in this study for any reason, 
please contact one of the research team members listed in question 3 of this form.  
They will tell you how to stop your participation safely.
If you have any questions regarding your rights as a research subject, please call the 
Institutional Review Board (IRB) office at (352) 273-9600.
13b.If you withdraw, can information about you still be used and/or collected?
If you withdraw your consent to participate, information used and/or collected from 
the date of consent up to the date of withdrawal may still be used by the 
investigators; however, no further information will be collected and used in the 
study.
13c. Can the Principal Investigator withdraw you from this study? 
You may be withdrawn from the study without your consent for the following reasons:

You choose not to have the standard of care shoulder injection;

The investigators decide that continuing in the study would be harmful to you; 

At a later time, you no longer consent to any future changes that may be made 
to this study plan;

Failure to complete follow-up surveys; or

For any other reason.
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WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
14. If you choose to take part in this research study, will it cost you anything?
No. There will be no extra cost to you for participating in this Research Study.
15. Will you be paid for taking part in this study?
You will not receive any payment for taking part in this study.
16.What if you are injured because of the study?  
Please contact the Principal Investigator listed in question 3 of this form if you 
experience an injury or have questions about any discomforts that you experience 
while participating in this study.
17. How will your health information be collected, used and shared?
If you agree to participate in this study, the Principal Investigator will create, collect, 
and use private information about you and your health. This information is called 
protected health information or PHI. In order to do this, the Principal Investigator 
needs your authorization.  The following section describes what PHI will be collected, 
used and shared, how it will be collected, used, and shared, who will collect, use or 
share it, who will have access to it, how it will be secured, and what your rights are to 
revoke this authorization. 
Your protected health information may be collected, used, and shared with others to 
determine if you can participate in the study, and then as part of your participation in 
the study.  This information can be gathered from you or your past, current or future 
health records, from procedures such as physical examinations, x-rays, blood or urine 
tests or from other procedures or tests.  This information will be created by receiving 
study treatments or participating in study procedures, or from your study visits and 
telephone calls.  More specifically, the following information may be collected, used, 
and shared with others: 

Demographic information including name, date of birth, sex 

Phone number, e-mail and mailing address for the purpose of follow-up 
surveys 

Records about phone calls made as part of this research

Past and present medical records

Records about your study visits

Information obtained during this research study about
o
Physical exams and prior operative exams
o
X-ray, and other test results
o
Responses to questionnaires and surveys 
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This information will be stored in locked filing cabinets or on computer servers with 
secure passwords, or encrypted electronic storage devices. 
Some of the information collected could be included in a "limited data set" to be used 
for other research purposes.  If so, the limited data set will only include information 
that does not directly identify you.  For example, the limited data set cannot include 
your name, address, telephone number, social security number, photographs, or 
other codes that link you to the information in the limited data set.  If limited data sets 
are created and used, agreements between the parties creating and receiving the 
limited data set are required in order to protect your identity and confidentiality and 
privacy.
18. For what study-related purposes will your protected health information be 
collected, used, and shared with others?
Your PHI may be collected, used, and shared with others to make sure you can 
participate in the research, through your participation in the research, and to evaluate 
the results of the research study.  More specifically, your PHI may be collected, used, 
and shared with others for the following study-related purpose(s):

To assess the effectiveness of a single cortisone injection in patients with 
shoulder arthritis.

To assess factors that can help clinicians predict the success of cortisone 
injections in patients with shoulder arthritis.
Once this information is collected, it becomes part of the research record for this 
study.
19. Who will be allowed to collect, use, and share your protected health 
information?
Only certain people have the legal right to collect, use and share your research 
records, and they will protect the privacy and security of these records to the extent 
the law allows. These people include:

The study Principal Investigator (listed in question 3 of this form) and research 
staff associated with this project.

Other professionals at the University of Florida or Shands Hospital that provide 
study-related treatment or procedures.

The University of Florida Institutional Review Board (IRB; an IRB is a group of 
people who are responsible for looking after the rights and welfare of people 
taking part in research).  
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20.  Once collected or used, who may your protected health information be shared 
with?
Your PHI may be shared with:

The study sponsor (listed in Question 4 of this form).

United States governmental agencies that are responsible for overseeing 
research, such as the Food and Drug Administration, the Department of Health 
and Human Services, and the Office of Human Research Protections.

Government agencies who are responsible for overseeing public health 
concerns such as the Centers for Disease Control and federal, state and local 
health departments.
Otherwise, your research records will not be released without your permission 
unless required by law or a court order. It is possible that once this information is 
shared with authorized persons, it could be shared by the persons or agencies who 
receive it and it would no longer be protected by the federal medical privacy law.  
21. If you agree to take part in this research study, how long will your protected 
health information be used and shared with others?
Your PHI will be used and shared with others until the end of the study.
You are not required to sign this consent and authorization or allow researchers to 
collect, use and share your PHI. Your refusal to sign will not affect your treatment, 
payment, enrollment, or eligibility for any benefits outside this research study. 
However, you cannot participate in this research unless you allow the collection, use 
and sharing of your protected health information by signing this consent and 
authorization.
You have the right to review and copy your protected health information.  However, 
we can make this available only after the study is finished.
You can revoke your authorization at any time before, during, or after your 
participation in this study.  If you revoke it, no new information will be collected 
about you.  However, information that was already collected may still be used and 
shared with others if the researchers have relied on it to complete the research.  
You can revoke your authorization by giving a written request with your signature on 
it to the Principal Investigator.
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SIGNATURES
As an investigator or the investigator’s representative, I have explained to the participant 
the purpose, the procedures, the possible benefits, and the risks of this research study; 
the alternative to being in the study; and how the participant’s protected health 
information will be collected, used, and shared with others: 
Signature of Person Obtaining Consent and 
Authorization
Date
You have been informed about this study’s purpose, procedures, possible benefits, and 
risks; the alternatives to being in the study; and how your protected health information will 
be collected, used and shared with others.  You have received a copy of this Form.  You 
have been given the opportunity to ask questions before you sign, and you have been 
told that you can ask   questions at any time.  
You voluntarily agree to participate in this study. You hereby authorize the collection, use 
and sharing of your protected health information as described in sections 17-21 above.  
By signing this form, you are not waiving any of your legal rights.
Signature of Person Consenting and Authorizing
Date
 
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4.  Who is paying for this research study? 
The sponsor of this study is The University of Florida.
5.  Why is this research study being done? 
The purpose of this research study is to determine how effective a single 
corticosteroid injection is in patients with shoulder arthritis. We are also interested in 
identifying clinical and radiographic (such as x-rays) indicators that could be used to 
help physicians predict how successful a corticosteroid (or cortisone) injection will be 
for patients with shoulder arthritis. 
You are being asked to be in this research study because you are a patient in the 
Department of Orthopaedics and Rehabilitation at University of Florida, age 18-100 
years, with painful shoulder arthritis, and have elected to receive a cortisone injection 
in your shoulder.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. 
 At most, the Web site will include a summary of the results. You can search this Web 
site at any time.
WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY?
6. What will be done as part of your normal clinical care (even if you did not 
participate in this research study)? 
Your shoulder physician may order one or more x-rays of your shoulder, even if you 
recently had other x-rays taken, to make sure they get the best views to properly 
assess the level of arthritis in your shoulder. Your physician has also determined that 
a cortisone injection in one or both of your shoulders may be beneficial to you. This 
procedure, and its benefits and risks, will be described in detail by your physician. 
These x-rays and course of treatment have been recommended regardless of your 
participation in this study.
7.  What will be done only because you are in this research study? 
You will be asked to complete a series of surveys or questionnaires about how your 
shoulder is feeling and functioning, and to let us know of any changes in your medical 
care such as medication changes at six (6) different time points throughout your care: 
to the day of your injection, and 2 weeks, 1 month, 2 months, 3 months, and 6 months 
after your injection. These surveys or questionnaires will take approximately 10-15 
minutes to complete. The follow-up surveys may be completed online through a link 
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sent to you by email or by a telephone call made to you by a member of the study 
staff. 
Information will also be copied from your medical record such as your shoulder pain 
history, previous shoulder injections, range of motion, and information from your 
shoulder x-rays or other radiographic studies (MRI or CT scan). 
If you have any questions now or at any time during the study, please contact one of 
the research team members listed in question 3 of this form.
8. How long will you be in this research study?
You will participate in this research study for 6 months following your cortisone 
injection. 
9. How many people are expected to take part in this research study?
500 subjects will be recruited to participate in this study.
WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND 
WHAT ARE YOUR OPTIONS?
10.What are the possible discomforts and risks from taking part in this research 
study?
You will be receiving a cortisone injection regardless of your participation in this study.  
There are certain discomforts or risks associated with any injection.  If you have any 
questions about these risks, please discuss these with your shoulder physician prior to 
receiving the injection.
Although a minimal risk, completing the study questionnaires may cause stress to 
some participants who may believe that they are not providing correct answers to the 
research team. To reduce this stress, the investigators will reassure you that all 
survey answers are based on what you feel, and there is no “correct” answer.
Researchers will take appropriate steps to protect any information they collect about 
you.  However, there is a slight risk that information about you could be revealed 
inappropriately or accidentally.  Depending on the nature of the information, such a 
release could upset or embarrass you, or possibly affect your insurability or 
employability.  Questions 17-21 in this form discuss what information about you will 
be collected, used, protected, and shared.
This study may include risks that are unknown at this time.
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Participation in more than one research study or project may further increase the 
risks to you.  If you are already enrolled in another research study, please inform 
one of the research team members listed in question 3 of this form or the person 
reviewing this consent with you before enrolling in this or any other research study 
or project.
Throughout the study, the researchers will notify you of new information that may 
become available and might affect your decision to remain in the study. 
If you wish to discuss the information above or any discomforts you may experience, 
please ask questions now or call one of the research team members or listed in 
question 3 of this form.
11a. What are the potential benefits to you for taking part in this research study?
There is no direct benefit to you by participating in this study.
11b. How could others possibly benefit from this study?
This study may benefit future patients by helping physicians identify clinical and 
radiographic (such as x-rays) indicators that could predict how successful a cortisone 
injection will be for patients with shoulder arthritis.
11c. How could the researchers benefit from this study?
In general, presenting research results helps the career of a scientist. Therefore, the 
Principal Investigator listed in question 3 may benefit if the results of this study are 
presented at scientific meetings or in scientific journals.
12.What other choices do you have if you do not want to be in this study? 
You may choose to not participate in this study. You may still receive the cortisone 
injection in your shoulder as previously determined by your physician; however, you
would not complete the questionnaires before or after the injection. 
If you do not want to take part in this study, tell the member of the research staff that 
is speaking to you about the study and do not sign this Informed Consent Form.
The investigators associated with this project may or may not be involved with your 
medical care before, during, and after this research study.  Your participation in this 
study is voluntary, and any decision to take part or not participate will in no way affect 
any medical care you receive from members of the research team.
If you believe that your participation in this study or your decision to withdraw from or 
to not participate in this study has improperly affected your medical care, you should 
discuss this with the IRB office.
If you have any questions regarding your rights as a research subject, please call the 
Institutional Review Board (IRB) office at (352) 273-9600.
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University of Florida Students:
You have been invited to participate in this research project because you are a student 
with painful shoulder arthritis and have elected to receive a cortisone injection in 
your shoulder.  The investigators associated with this project may or may not teach in 
your college or be associated with courses for which you are enrolled or might be 
expected to register in the future.  Your participation in this study is voluntary and any 
decision to take part or not to participate will in no way affect your grade or class 
standing.
If you believe that your participation in this study or your decision to withdraw from or 
to not participate in this study has improperly affected your grade(s), you should 
discuss this with the dean of your college or you may contact the IRB office.
13a. Can you withdraw from this study?
You are free to withdraw your consent and to stop participating in this study at any 
time.  If you do withdraw your consent, you will not be penalized in any way and you 
will not lose any benefits to which you are entitled.
If you decide to withdraw your consent to participate in this study for any reason, 
please contact one of the research team members listed in question 3 of this form.  
They will tell you how to stop your participation safely.
If you have any questions regarding your rights as a research subject, please call the 
Institutional Review Board (IRB) office at (352) 273-9600.
13b.If you withdraw, can information about you still be used and/or collected?
If you withdraw your consent to participate, information used and/or collected from 
the date of consent up to the date of withdrawal may still be used by the 
investigators; however, no further information will be collected and used in the 
study.
13c. Can the Principal Investigator withdraw you from this study? 
You may be withdrawn from the study without your consent for the following reasons:

You choose not to have the standard of care shoulder injection;

The investigators decide that continuing in the study would be harmful to you; 

At a later time, you no longer consent to any future changes that may be made 
to this study plan;

Failure to complete follow-up surveys; or

For any other reason.
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WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
14. If you choose to take part in this research study, will it cost you anything?
No. There will be no extra cost to you for participating in this Research Study.
15. Will you be paid for taking part in this study?
You will not receive any payment for taking part in this study.
16.What if you are injured because of the study?  
Please contact the Principal Investigator listed in question 3 of this form if you 
experience an injury or have questions about any discomforts that you experience
while participating in this study.
17. How will your health information be collected, used and shared?
If you agree to participate in this study, the Principal Investigator will create, collect, 
and use private information about you and your health. This information is called 
protected health information or PHI. In order to do this, the Principal Investigator 
needs your authorization.  The following section describes what PHI will be collected, 
used and shared, how it will be collected, used, and shared, who will collect, use or 
share it, who will have access to it, how it will be secured, and what your rights are to 
revoke this authorization. 
Your protected health information may be collected, used, and shared with others to 
determine if you can participate in the study, and then as part of your participation in 
the study.  This information can be gathered from you or your past, current or future 
health records, from procedures such as physical examinations, x-rays, blood or urine 
tests or from other procedures or tests.  This information will be created by receiving 
study treatments or participating in study procedures, or from your study visits and 
telephone calls.  More specifically, the following information may be collected, used, 
and shared with others: 

Demographic information including name, date of birth, sex 

Phone number, e-mail and mailing address for the purpose of follow-up 
surveys 

Records about phone calls made as part of this research

Past and present medical records

Records about your study visits

Information obtained during this research study about
o
Physical exams and prior operative exams
o
X-ray, and other test results
o
Responses to questionnaires and surveys 
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This information will be stored in locked filing cabinets or on computer servers with 
secure passwords, or encrypted electronic storage devices. 
Some of the information collected could be included in a "limited data set" to be used 
for other research purposes.  If so, the limited data set will only include information 
that does not directly identify you.  For example, the limited data set cannot include 
your name, address, telephone number, social security number, photographs, or 
other codes that link you to the information in the limited data set.  If limited data sets 
are created and used, agreements between the parties creating and receiving the 
limited data set are required in order to protect your identity and confidentiality and 
privacy.
18. For what study-related purposes will your protected health information be 
collected, used, and shared with others?
Your PHI may be collected, used, and shared with others to make sure you can 
participate in the research, through your participation in the research, and to evaluate 
the results of the research study.  More specifically, your PHI may be collected, used, 
and shared with others for the following study-related purpose(s):

To assess the effectiveness of a single cortisone injection in patients with 
shoulder arthritis.

To assess factors that can help clinicians predict the success of cortisone 
injections in patients with shoulder arthritis.
Once this information is collected, it becomes part of the research record for this 
study.
19. Who will be allowed to collect, use, and share your protected health 
information?
Only certain people have the legal right to collect, use and share your research 
records, and they will protect the privacy and security of these records to the extent 
the law allows. These people include:

The study Principal Investigator (listed in question 3 of this form) and research 
staff associated with this project.

Other professionals at the University of Florida or Shands Hospital that provide 
study-related treatment or procedures.

The University of Florida Institutional Review Board (IRB; an IRB is a group of 
people who are responsible for looking after the rights and welfare of people 
taking part in research).  
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20.  Once collected or used, who may your protected health information be shared 
with?
Your PHI may be shared with:

The study sponsor (listed in Question 4 of this form).

United States governmental agencies that are responsible for overseeing 
research, such as the Food and Drug Administration, the Department of Health 
and Human Services, and the Office of Human Research Protections.

Government agencies who are responsible for overseeing public health 
concerns such as the Centers for Disease Control and federal, state and local 
health departments.
Otherwise, your research records will not be released without your permission 
unless required by law or a court order. It is possible that once this information is 
shared with authorized persons, it could be shared by the persons or agencies who 
receive it and it would no longer be protected by the federal medical privacy law.  
21. If you agree to take part in this research study, how long will your protected 
health information be used and shared with others?
Your PHI will be used and shared with others until the end of the study.
You are not required to sign this consent and authorization or allow researchers to 
collect, use and share your PHI. Your refusal to sign will not affect your treatment, 
payment, enrollment, or eligibility for any benefits outside this research study. 
However, you cannot participate in this research unless you allow the collection, use 
and sharing of your protected health information by signing this consent and 
authorization.
You have the right to review and copy your protected health information.  However, 
we can make this available only after the study is finished.
You can revoke your authorization at any time before, during, or after your 
participation in this study.  If you revoke it, no new information will be collected 
about you.  However, information that was already collected may still be used and 
shared with others if the researchers have relied on it to complete the research.  
You can revoke your authorization by giving a written request with your signature on 
it to the Principal Investigator.
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SIGNATURES
As an investigator or the investigator’s representative, I have explained to the participant 
the purpose, the procedures, the possible benefits, and the risks of this research study; 
the alternative to being in the study; and how the participant’s protected health 
information will be collected, used, and shared with others: 
Signature of Person Obtaining Consent and 
Authorization
Date
You have been informed about this study’s purpose, procedures, possible benefits, and 
risks; the alternatives to being in the study; and how your protected health information will 
be collected, used and shared with others.  You have received a copy of this Form.  You 
have been given the opportunity to ask questions before you sign, and you have been 
told that you can ask   questions at any time.  
You voluntarily agree to participate in this study. You hereby authorize the collection, use
and sharing of your protected health information as described in sections 17-21 above.  
By signing this form, you are not waiving any of your legal rights.
Signature of Person Consenting and Authorizing
Date
Study ID:IRB201700603   Date Approved: 8/2/2017   Expiration Date: 4/26/2020