Conditions: Shoulder Pain
Keywords: subacromial injection rotator cuff disease steroid injection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: no

Brief summary:
The specific aim of this prospective study is to determine whether local anesthetics prior to subacromial steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder pathology.

Detailed description:
Shoulder pain is a common problem that can be estimated to be prevalent in up to 15 percent of the patient population registered to general practices and is second only to back pain in patients seeking treatment for musculoskeletal issues in the primary care setting. As a common source of distress, shoulder pain contributes significantly to health care costs.

Rotator cuff disease due to impingement, tendonitis or bursitis is a frequent cause of shoulder pain and dysfunction. Initial treatment consists of a conservative approach of activity modification, oral nonsteroidal anti-inflammatory drugs (NSAIDs) and supervised physical therapy. However, if the patients' symptoms persist, subacromial injections of a local anesthetic such as lidocaine, and a corticosteroid may be indicated as a sequential treatment option.

The steroid injection itself can be a painful process, so administering a local anesthetic prior to the steroid injection is thought to mitigate pain or reduce possible discomfort during and immediately following the procedure. Though there is evidence advocating for the benefits of combining local anesthetics and corticosteroids for the treatment of subacromial pathologies, it is not conclusive whether local anesthesia significantly enhances the pain relieving effect of steroids. Should local anesthesia not have a significant impact on the patient's pain intensity, then the use of corticosteroids alone could potentially result in reduced costs in care.

Arms:
arm 1: Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine arm 2: Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection arm 3: Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds

Interventions: intervention 1: lidocaine intervention 2: ethyl chloride intervention 3: Kenalog
Intervention descriptions: intervention 1: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection intervention 2: topical spray intervention 3: used with lidocaine in shoulder injection

Protocol document:
Prot_SAP_001.pdf: 
Page 1 of 19 (V.08/18/2015) 
 
 
 
 
HRP-592 - Protocol for Human Subject  
Research with Use of Test Article(s) 
 
Protocol Title: 
The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections 
 
 
Principal Investigator: 
Name: Robert Gallo, MD 
Department:  Orthopaedics and Rehabilitation 
Telephone: 531-5638 
E-mail Address: rgallo@hmc.psu.edu 
 
Version Date: 
2/8/2016 
 
Clinicaltrials.gov Registration #:  NCT02592629 
 
 


Page 2 of 19 (V.08/18/2015) 
Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Subject Numbers and Statistical Plan 
9.0 
Confidentiality, Privacy and Data Management 
10.0 
Data and Safety Monitoring Plan 
11.0 
Risks 
12.0 
Potential Benefits to Subjects and Others 
13.0 
Sharing Results with Subjects 
14.0 
Subject Stipend (Compensation) and/or Travel Reimbursements 
15.0 
Economic Burden to Subjects 
16.0 
Resources Available 
17.0 
Other Approvals 
18.0 
Multi-Site Research 
19.0 
Adverse Event Reporting 
20.0 
Study Monitoring, Auditing and Inspecting 
21.0 
Future Undetermined Research: Data and Specimen Banking 
22.0 
References 
 
 
 
 
 


Page 3 of 19 (V.08/18/2015) 
1.0 
Objectives 
 
1.1 
Study Objectives 
The specific aim of this prospective study is to determine whether local anesthetics prior to subacromial 
steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder 
pathology. 
 
Hypothesis: Patients undergoing subacromial steroid injections without local anesthetics will have 
significantly increased pain than those who do use anesthetics prior to undergoing the injections. 
 
Standard of Care: Giving local anesthetics in addition to the steroid injection. Both of these treatment 
options are available to patients even if they are not undergoing the study. 
  
 
1.2 
Primary Study Endpoints 
The primary endpoint is to determine whether local anesthetics prior to subacromial injections reduce 
pain, quantified on a 1-10 pain scale. 
 
 
1.3 
Secondary Study Endpoints 
Not applicable 
 
2.0 
Background 
 
2.1 
Scientific Background and Gaps 
Shoulder pain is a common problem that can be estimated to be prevalent in up to 15 percent of the 
patient population registered to general practices and is second only to back pain in patients seeking 
treatment for musculoskeletal issues in the primary care setting. As a common source of distress, 
shoulder pain contributes significantly to health care costs. In the US, it directly attributes $7 billion to 
costs in the year 2000, with a mean cost per care episode of $1667 and $3011 for outpatient and 
hospital-based settings, respectively. 
 
Rotator cuff disease due to impingement, tendonitis or bursitis is a frequent cause of shoulder 
pain and dysfunction. Initial treatment consists of a conservative approach of activity modification, oral 
nonsteroidal anti-inflammatory drugs (NSAIDs) and supervised physical therapy. However, if the 
patients’ symptoms persist, subacromial injections of a local anesthetic such as lidocaine, and a 
corticosteroid may be indicated as a sequential treatment option. 
 
The steroid injection itself can be a painful process, so administering a local anesthetic prior to 
the steroid injection is thought to mitigate pain or reduce possible discomfort during and immediately 
following the procedure. A survey of 835 rheumatologists found that 74.7 percent of those who trained 
after 1985 combined lidocaine and steroids for soft tissue and joint injections. Though there is evidence 
advocating for the benefits of combining local anesthetics and corticosteroids for the treatment of 
subacromial pathologies, it is not conclusive whether local anesthesia prior to steroid injections 
significantly enhances the pain relieving effect of steroids. Should local anesthesia not have a significant 
impact on the patient’s pain intensity, then the use of corticosteroids alone could potentially result in 
reduced costs in care. 
 
2.2 
Previous Data 
Not applicable 
 


Page 4 of 19 (V.08/18/2015) 
2.3 
Study Rationale 
Though there is evidence advocating for the benefits of combining local anesthetics and corticosteroids 
for the treatment of subacromial pathologies, it is not conclusive whether local anesthesia enhances the 
pain relieving effect of steroids. Should local anesthesia not have a significant impact on the patient’s 
pain intensity as detected by self-assessment via pain scale, then the use of corticosteroids alone could 
potentially result in reduced costs in care. 
 
3.0 
Inclusion and Exclusion Criteria 
 
3.1 
Inclusion Criteria 
• 
Adults aged 18-70 
• 
Shoulder pain lasting at least 4 weeks  
• 
Inability to use arm with restriction of movement and loss of full function.  
• 
Able to understand study and provide voluntary, written informed consent 
 
3.2 
Exclusion Criteria 
• 
Less than 18 or greater than 70 years old 
• 
Contraindications of previous injections and previous shoulder surgery 
• 
Unable to understand consent form (in the opinion of the PI) 
• 
Non-English speaking individuals 
• 
Medication contradictions to lidocaine, corticosteroids 
 
3.3 
Early Withdrawal of Subjects 
 
3.3.1 
Criteria for removal from study 
Patients will be withdrawn from the study for safety reasons including severe adverse reactions, 
failure of subject to adhere to protocol requirements, or subject consent withdrawal. 
 
3.3.2 
Follow-up for withdrawn subjects 
The subjects may withdraw at any point prior to the steroid injection. Additionally, they may 
elect not to participate in rating their pain right after they receive the injections. Subjects who 
withdraw and prefer to have a lidocaine injection, may still participate in rating their pain after 
the lidocaine + steroid injection. Any subject who is getting steroid injections for shoulder pain 
may replace subjects who withdrew. 
 
4.0 
Recruitment Methods 
 
4.1 
Identification of subjects 
Subjects will be identified as part of their initial or routine evaluation by one of the study investigators in 
the Bone & Joint Institute.   
 
4.2 
Recruitment process 
If steroid injections are indicated for subjects with shoulder pathologies who come to the Orthopedics 
department, they will be asked to participate in the study. 
 
4.3 
Recruitment materials 
Not applicable. 
 


Page 5 of 19 (V.08/18/2015) 
4.4 
Eligibility/screening of subjects 
Adult patients presenting to the Bone & Joint Institute will be evaluated as part of standard of care.  
Those subjects meeting eligibility requirements will be presented with the opportunity to participate in 
the research study by a member of the research team. 
 
 


Page 6 of 19 (V.08/18/2015) 
5.0 
Consent Process and Documentation 
 
5.1 
Consent Process  
  
5.1.1 
Obtaining Informed Consent 
 
5.1.1.1 
Timing and Location of Consent 
Subjects presenting to the study investigator’s practice site as part of their initial 
or routine evaluation will be given the opportunity to participate in the research 
study.  Patients will be given information about the study and asked to 
participate.  If eligible, based on inclusion and exclusion criteria, informed 
consent will be obtained at the time of the screening visit and the patient will be 
enrolled in the study. 
 
5.1.1.2 
Coercion or Undue Influence during Consent 
Subjects will be given ample time to read and review the consent form on their 
own.  All questions the patient may have will be answered and written consent 
will be obtained.  A member of the research team will assist in the explanation 
and obtaining of the written consent.  A copy of the signed consent will be given 
to the patient and another copy sent to Medical Records. Subjects will be 
informed they do not have to participate in this research study. They will be 
informed that their current and future care at the PSHMC will not be affected by 
their decision to accept or decline participation. 
 
5.1.2 
Waiver or alteration of the informed consent requirement 
Requesting a waiver to screen for eligibility prior to the informed consent document being 
signed. 
 
5.2 
Consent Documentation 
 
5.2.1 
Written Documentation of Consent 
A member of the research team will assist in the explanation and obtaining of the written 
consent.  A copy of the signed consent will be given to the patient and another copy sent to 
Medical Records. 
 
5.2.2 
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.) 
Not applicable. 
 
5.3 
Consent – Other Considerations  
 
5.3.1 
Non-English Speaking Subjects 
Not applicable. 
 
5.3.2 
Cognitively Impaired Adults 
 
5.3.2.1 Capability of Providing Consent 
Not applicable. 
 
5.3.2.2 
Adults Unable To Consent 
Not applicable. 
 
5.3.2.3 Assent of Adults Unable to Consent 


Page 7 of 19 (V.08/18/2015) 
Not applicable. 
 
5.3.3 
Subjects who are not yet adults (infants, children, teenagers)  
 
5.3.3.1 Parental Permission 
Not applicable. 
 
5.3.3.2 Assent of subjects who are not yet adults 
Not applicable. 
 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
Check all that apply: 
  
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable] 
 
 
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable] 
 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3] 
 
 
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3] 
 
 
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3] 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual 
 
6.2.1.1 Plan to protect PHI from improper use or disclosure 
Information is included in the “Confidentiality, Privacy and Data Management” 
section of this protocol. 
 
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers  
The list will be destroyed upon completion of the study. 
 
6.2.2 
Explanation for why the research could not practicably be conducted without access to and 
use of PHI 
Patient identifiers are necessary for identification and review of the patient’s medical records.  A 
unique study code number will be used for identification of study data.  The linking list will be 
destroyed upon completion of the study. 
 
6.2.3 
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization 
Waiver is required to screen for eligibility. 


Page 8 of 19 (V.08/18/2015) 
 
6.3 
Waiver or alteration of authorization statements of agreement 
Protected health information obtained as part of this research will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the research study, or for 
other permitted uses and disclosures according to federal regulations.  
 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) 
per federal regulations.  
 
Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented. 
 
7.0 
Study Design and Procedures 
 
7.1 
Study Design 
The trial is a randomized,  prospective study. Patients undergoing steroid injections will be randomized 
into three groups:  
• 
Group A=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine 
• 
Group B=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml in 
subcutaneous injection 
• 
Group C=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying 
ethyl chloride spray for 3 seconds 
 
Patients’ pre and post-procedural pain as well as the pain of the injection itself will be assessed with a 
visual pain scale and the results will be analyzed for statistical significance.  
 
7.2 
Study Procedures 
The study consists of one visit in clinic during their standard of care visit. Patients will be given 
information about the study and asked to participate.  If eligible, based on inclusion and exclusion 
criteria, informed consent will be obtained at the time of the screening visit and the patient will be 
enrolled in the study.   
 
After obtaining informed consent, the patient will be asked to rate their current pain on a visual 1-10 
point scale before injection.  They will then be randomized to one of three treatment groups.  The study 
investigator will randomly draw a sealed envelope containing one of the three treatment groups.  The 
sealed envelopes will be stored in a secure area within the clinic practice site.  The subject will be 
randomized to one of three groups: 
• 
Group A=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine 
• 
Group B=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml in 
subcutaneous injection 
• 
Group C=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying 
ethyl chloride spray for 3 seconds 
 
The needle size will be standardized: 
• 
        25 gauge needle for the subcutaneous lidocaine injection 
• 
        21 gauge needle for the combined injection 
 
Immediately after and ten minutes after the injection is completed, they will also be asked to rate pain 
on the same 1-10 visual scale. 


Page 9 of 19 (V.08/18/2015) 
 
No long-term follow-up will be conducted. 
 
7.3 
Duration of Participation 
The subject will only be participating from the time they receive the injection to when they indicate the 
level of pain on the pain scale; i.e. they will be seen in the clinic site once. 
 
7.4 
Test Article(s) (Study Drug(s) and/or Study Device(s)) 
 
7.4.1 Description 
All of these drugs  and listed dosages are currently FDA approved and considered standard of 
care. 
 
Lidocaine hydrochloride injection: USP is sterile, nonpyrogenic, aqueous solution that contains a 
local anesthetic agents and is administered parenterally by injection. It is FDA approved and 
indicated for production of local or regional anesthesia by infiltration techniques such as steroid 
injections 
 
Ethyl Chloride spray: a vapocoolant (skin refrigerant) intended for topical application to control 
pain associated with injections. It is FDA approved. 
 
 
Kenalog Injection (triamcinolone acetonide): a synthetic glucocorticoid corticosteroid with anti-
inflammatory action. This formulation is FDA approved for intramuscular and intra-articular use 
only 
 
7.4.2 Treatment Regimen 
o Group A=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine 
o Group B=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml in 
subcutaneous injection 
o Group C=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl 
chloride spray for 3 seconds 
 
7.4.3 Method for Assigning Subject to Treatment Groups 
The subjects will be randomized by drawing a treatment group from a sealed envelope. 
 
7.4.4 Subject Compliance Monitoring 
Subject compliance monitoring is not necessary as there will only be 1 treatment protocol for 
this study. 
 
7.4.5 Blinding of the Test Article 
Not applicable. 
 
7.4.6 
Receiving, Storage, Dispensing and Return  
 
7.4.6.1 
Receipt of Test Article  
The compounds are used in the Bone & Joint Institute as standard of care.   
 
7.4.6.2 
Storage 
The compounds will be stored at room temperature in the Bone & Joint Institute 
as per standard of care instructions.  


Page 10 of 19 (V.08/18/2015) 
7.4.6.3 
Preparation and Dispensing 
The study drug will be prepared by an investigator following standard of care 
protocols. Subject randomization will be performed prior to dispensing of any 
study drugs. Once the needle is in the proper location, the solution of steroid 
will be injected slowly. A 2 mL solution of 1% lidocaine without epinephrine will 
be injected subcutaneously prior to the steroid injection if the subject is 
randomized into group B. If subject is in group C, ethyl chloride spray will be 
applied for 3 seconds prior the steroid injection. 
 
7.4.6.4 
Return or Destruction of the Test Article 
The study drug will be disposed of in clinic following standard procedure for 
disposal of needles. 
 
7.4.6.5 
 Prior and Concomitant Therapy 
No prior and concomitant therapy will be collected. 
 
8.0 
Subject Numbers and Statistical Plan 
 
8.1 
Number of Subjects 
            Approximately 150 subjects (50 per treatment arm). 
 
8.2 
Sample size determination 
The primary endpoint is the change in visual pain scale from baseline (pre-injection) to follow up (0- and 
10-minutes after injection).  The study contains 3 groups:   
o Group A=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine 
o Group B=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml in 
subcutaneous injection 
o Group C=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl 
chloride spray for 3 seconds 
 
Comparisons will be made for the primary outcome between all 3 study groups: Group B vs. A; Group C 
vs. A; and Group C vs. B.  Thus, we used a Bonferonni corrected Type I error rate for 3 tests to determine 
the sample size required for 80% power.   
 
A total of N=50 patients per group (N=150 total) yields 80% power for a t-test conducted at the 
Bonferonni corrected Type I error rate of 1.7%, which holds the overall Type I error rate for the study at 
5%, to detect a 2-point difference in pain scale changes between groups, assuming a common standard 
deviation of 3 points.  The standard deviation was calculated after making a conservative assumption 
that visual pain scores would be uniformly distributed across 0-10. 
 
8.3 
Statistical methods 
A one-way analysis of variance (ANOVA) model will be used to test whether changes in pain scores differ 
by study group. The outcome variable for the model will be the change in pain scores, and the 
independent variables will be indicators of each study group.  The overall F-test for study group will be 
used to determine whether study groups differ with respect to mean changes in visual pain scores.  If 
the F-test is significant, then follow up tests comparing each set of groups will be conducted using the 
Bonferonni-adjusted Type I error rate of 1.7%.    
 
9.0 
Confidentiality, Privacy and Data Management  
See the Research Data Plan Review Form 
 


Page 11 of 19 (V.08/18/2015) 
9.1 
Confidentiality 
 
9.1.1 
Identifiers associated with data and/or specimens 
 
9.1.1.1 Use of Codes, Master List 
 
9.1.2 
Storage of Data and/or Specimens 
 
9.1.3 
Access to Data and/or Specimens 
 
9.1.4 
Transferring Data and/or Specimens 
 
9.2 
Subject Privacy 
 
10.0 Data and Safety Monitoring Plan 
 
10.1 
Periodic evaluation of data 
The research coordinator will complete the appropriate report form and logs; assist the 
principal investigator to prepare reports and notify the IRB and any applicable reporting 
agencies of all unanticipated problems / adverse events. 
 
The research coordinator and principal investigator will confirm that all adverse events are 
correctly entered in the AE log; be available to answer any questions concerning AEs; notify the 
IRB and any applicable reporting agencies of unanticipated problems and AEs as appropriate.  
All assessments of AEs will be made by a licensed medical professional who is an investigator on 
the research. 
 
10.2 
Data that are reviewed 
Data to be reviewed includes incidence of adverse effects collected data. 
 
10.3 
Method of collection of safety information 
Not applicable. 
 
10.4 
Frequency of data collection 
Not applicable. 
 
10.5 
Individuals reviewing the data 
Not applicable. 
 
10.6 
Frequency of review of cumulative data 
There will be an interim analysis in this study after 50% of patients are enrolled and have completed all 
study requirements. Adverse events will be reviewed as they occur. 
 
10.7 
Statistical tests 
A one-way analysis of variance (ANOVA) model will be used to test whether changes in pain scores differ 
by study group. The outcome variable for the model will be the change in pain scores, and the 
independent variables will be indicators of each study group.  The overall F-test for study group will be 
used to determine whether study groups differ with respect to mean changes in visual pain scores.  If 
the F-test is significant, then follow up tests comparing each set of groups will be conducted using the 
Bonferonni-adjusted Type I error rate of 1.7%.   
 


Page 12 of 19 (V.08/18/2015) 
10.8 
Suspension of research 
There will be no stopping rules in this study as all medications are FDA approved and safe for patient 
use.   
 
If a patient, at any point in the course of their treatment demonstrates a significant adverse event 
related to the study medication, then the adverse event will be addressed. 
 
 


Page 13 of 19 (V.08/18/2015) 
11.0 Risks 
Loss of confidentiality will be minimized as the research team will only have access to the research data and all 
information will be kept in a shared research file in Hersheymed.net on a password-protected computer, in the 
Orthopaedic research office locked filing cabinets. 
 
Subjects will be assigned to a treatment program by chance. The treatment received may prove to be less 
effective or to have more side effects than the other research treatment(s) or other available treatments.   
 
Ethyl Chloride - freezing may alter skin pigment 
 
Kenalog - joint tissue damage, swelling in your veins, allergic reaction, infection, increase in blood sugar.   
 
Lidocaine - itching, rash, swelling of the skin, pain at the injection site, numbness, dizziness, and allergic 
reactions.  Rarely, when injected into the blood stream lidocaine can cause confusion, coma, seizures, 
respiratory arrest, heart beat irregularities, and toxicities; however, in this study lidocaine will not be injected 
into your bloodstream. 
 
Nerve damage for a period of time after the injection. 
 
12.0 Potential Benefits to Subjects and Others 
 
12.1 
Potential Benefits to Subjects 
The treatment received may prove to be less or more effective or to have more side effects than the 
other research treatment or other available treatments. 
 
12.2 
Potential Benefits to Others 
The potential benefit may be a way to reduce healthcare cost by decreasing the over-utilization of 
unnecessary materials/procedures. The results of this study will guide future treatment decisions. 
 
13.0 Sharing Results with Subjects 
            The results will not be shared. 
 
14.0 Subject Stipend (Compensation) and/or Travel Reimbursements 
Not applicable 
 
15.0 Economic Burden to Subjects 
 
15.1 
Costs  
All procedures are standard of care and will be billed to insurance. The subjects will be liable for any co-
pays, deductibles, or other fees associated with their insurance policy. 
 
15.2 
Compensation for research-related injury 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers.  
 


Page 14 of 19 (V.08/18/2015) 
16.0 Resources Available 
 
16.1 
Facilities and locations 
Research will be conducted at the Penn State Hershey Bone and Joint Institute. 
 
16.2 
Feasibility of recruiting the required number of subjects 
The Penn State Hershey Bone and Joint Institute cares for many patients with shoulder problems that 
need to get steroid injections to relieve pain. The PI does 1-2 injections per clinic and has 2 clinics a 
week. After 52 weeks the sample size would be around 150, which is above the 138 subject sample size 
calculated by the edited stats analysis.  
 
16.3 
PI Time devoted to conducting the research 
Dr. Gallo has research time determined in his agreement with the Orthopaedic Department.  
 
16.4 
Availability of medical or psychological resources 
If any medical or psychological care is needed for a subject, they will be directed for standard of care 
treatment at Hershey Medical Center. 
 
16.5 
Process for informing Study Team 
All team members have been given copies of all IRB approved documents – protocol, data collection 
tools, approval memos, etc.  The team meets regularly to review data and any updates. 
 
17.0 Other Approvals 
 
17.1 
Other Approvals from External Entities 
Not applicable. 
 
17.2 
Internal PSU Committee Approvals 
 
Check all that apply: 
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of the Use of Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available on the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/forms 
 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals 
 
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA or 
gene therapy).  
 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest. 
 
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload the 
Radiation Review Form on the “Supporting Documents” page in CATS IRB. This form is available on the 
IRB website at: http://www.pennstatehershey.org/web/irb/home/resources/forms 
 


Page 15 of 19 (V.08/18/2015) 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE. 
 
  Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The scientific 
review requirement may be fulfilled by one of the following: (1) external peer-review process; (2) 
department/institute scientific review committee; or (3) scientific review by the Clinical Research Center 
Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute Scientific Review 
Committee is required if the study involves cancer prevention studies or cancer patients, records and/or 
tissues. For more information about this requirement see the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/investigator  
 
18.0 Multi-Site Research 
 
18.1 
Communication Plans 
not applicable 
 
18.2 
Data Submission and Security Plan 
not applicable 
 
18.3 
Subject Enrollment 
not applicable 
 
18.4 
Reporting of Adverse Events and New Information 
not applicable 
 
18.5 
Audit and Monitoring Plans 
not applicable 
 
19.0 Adverse Event Reporting 
 
19.1 
Adverse Event Definitions 
 
 
Adverse event 
Any untoward medical occurrence associated with the use of the drug in 
humans, whether or not considered drug related 
Adverse reaction 
Any adverse event caused by a drug 
Suspected adverse 
reaction 
Any adverse event for which there is a reasonable possibility that the drug 
caused the adverse event.  Suspected adverse reaction implies a lesser degree of 
certainty about causality than “adverse reaction”. 
• 
Reasonable possibility.  For the purpose of IND safety reporting, 
“reasonable possibility” means there is evidence to suggest a causal 
relationship between the drug and the adverse event. 
Serious adverse 
event or Serious 
suspected adverse 
reaction 
Serious adverse event or Serious suspected adverse reaction: An adverse event 
or suspected adverse reaction that in the view of either the investigator or 
sponsor, it results in any of the following outcomes: Death, a life-threatening 
adverse event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption of 
the ability to conduct normal life functions, or a congenital anomaly/birth defect. 
Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate 


Page 16 of 19 (V.08/18/2015) 
medical judgment, they may jeopardize the patient or subject and may require 
medical or surgical intervention to prevent one of the outcomes listed in this 
definition.  
Life-threatening 
adverse event or 
life-threatening 
suspected adverse 
reaction 
An adverse event or suspected adverse reaction is considered “life-threatening” 
if, in the view of either the Investigator (i.e., the study site principal investigator) 
or Sponsor, its occurrence places the patient or research subject at immediate 
risk of death.  It does not include an adverse event or suspected adverse reaction 
that had it occurred in a more severe form, might have caused death. 
Unexpected 
adverse event or 
Unexpected 
suspected adverse 
reaction.   
An adverse event or suspected adverse reaction is considered “unexpected” if it 
is not listed in the investigator brochure, general investigational plan, clinical 
protocol, or elsewhere in the current IND application; or is not listed at the 
specificity or severity that has been previously observed and/or specified. 
 
 
 
For device studies, incorporate the following definitions into the below responses, as written: 
Unanticipated 
adverse device 
effect 
Any serious adverse effect on health or safety or any life-threatening problem or 
death caused by, or associated with, a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or IDE application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects. 
 
19.2 
Recording of Adverse Events 
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or its 
sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the investigator. 
 
An abnormal test finding will be classified as an adverse event if one or more of the following criteria are 
met: 
• 
The test finding is accompanied by clinical symptoms 
• 
The test finding necessitates additional diagnostic evaluation(s) or medical/surgical intervention; 
including significant additional concomitant drug treatment or other therapy 
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does not 
constitute an adverse event. 
• 
The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study 
The test finding is considered an adverse event by the investigator. 
 
19.3 
Causality and Severity Assessments 
The investigator will promptly review documented adverse events and abnormal test findings to 
determine 1) if the abnormal test finding should be classified as an adverse event; 2) if there is a 
reasonable possibility that the adverse event was caused by the study drug(s) or device(s); and 3) if the 
adverse event meets the criteria for a serious adverse event. 
 
If the investigator’s final determination of causality is “unknown and of questionable relationship to the 
study drug(s) or device(s)”, the adverse event will be classified as associated with the use of the study 
drug(s) or device(s) for reporting purposes.  If the investigator’s final determination of causality is 
“unknown but not related to the study drug(s) or device(s)”, this determination and the rationale for the 
determination will be documented in the respective subject’s case history. 
 


Page 17 of 19 (V.08/18/2015) 
19.4 
Reporting of Adverse Reactions and Unanticipated Problems to the FDA   
 
19.4.1 Written IND/IDE Safety Reports 
Not applicable. 
 
19.4.2 Telephoned IND Safety Reports – Fatal or Life-threatening Suspected Adverse Reactions 
Not applicable. 
 
19.5 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
 
19.6 
Unblinding Procedures 
Not applicable. 
 
19.7 
Stopping Rules 
The study will be stopped if one method is found to be clearly superior or if there are adverse reactions. 
 
20.0 Study Monitoring, Auditing and Inspecting 
 
20.1 
Study Monitoring Plan  
 
 
20.1.1 Quality Assurance and Quality Control 
Study data will be recorded and kept in a shared folder on hersheymed.net in a restricted file 
accessible by investigators on the study.  The Principal Investigator will oversee all aspects of the 
study including monitoring. 
 
20.1.2 Safety Monitoring 
The Principal Investigator will confirm that all adverse events (AE) are correctly entered into the 
AE case report forms by the coordinator; be available to answer any questions that the 
coordinators may have concerning AEs; and will notify the IRB, FDA, sponsor and/or DSMB of all 
applicable AEs as appropriate. All assessments of AEs will be made by a licensed medical 
professional who is an investigator on the research. 
 
The Research Coordinator will complete the appropriate report form and logs; assist the PI to 
prepare reports and notify the IRB, FDA and/or DSMB of all Unanticipated Problems/SAE’s. 
 
The Monitor will confirm that the AEs are correctly entered into the case report forms. The 
Monitor will also confirm that the adverse events are consistent with the source documents and 
are reported to the appropriate regulatory bodies as required. 
 
20.2 
Data and/or specimens being stored 
Regulatory work, paper copies of data, electronic copies of data. 
 
20.3 
Location of storage 
Paper regulatory work and data will be kept at 30 Hope dr. suite 2900 in locked files. 
Electronic data will be kept in hersheymed.net investigator accessible shared files. 
 


Page 18 of 19 (V.08/18/2015) 
20.4 
Duration of storage 
Data will be kept at least 6 years, and disposed as per the PI. 
 
20.5 
Access to data and/or specimens 
Data will only be accessible by investigators listed on the study. 
 
20.6 
Procedures to release data or specimens 
not applicable 
 
20.7 
Process for returning results 
not applicable 
 


Page 19 of 19 (V.08/18/2015) 
21.0 References 
1. 
Badcock LJ, Lewis M, Hay EM, et al. Chronic shoulder pain in the community: a syndrome of disability or 
distress? Ann Rheum Dis 2002; 61: 128–131 
Steinfeld R, Valente RM, Stuart MJ. A common sense approach to shoulder problems. Mayo Clin Proc. 
199974(8):785–794. 
2. 
Johnson MP, Crossley KL, O’Neil ME, Al-Zakwani IS. Estimates of direct health care expenditures among 
individuals with shoulder dysfunction in the United States; Paper presented at the 2004 Annual Meeting of the 
American Society of Shoulder and Elbow Therapists; September 29–October 2, 2004; New York, NY. 
3. 
Burbank, K, Stevenson J, Czarnecki G, Dorfman J. Chronic Shoulder Pain: Part II. Treatment. Am Fam 
Physician. 2008 Feb 15;77(4):493-497. 
4. 
Radnovich R, Marriott T, Int J Gen Med. 2013; 6: 641–646. Published online 2013 July 30. doi: 
10.2147/IJGM.S47084 
5. 
Centeno LM, Moore ME. Preferred intraarticular corticosteroids and associated practice: a survey of 
members of the American College of Rheumatology. Arthritis Care Res. 1994;7(3):151–155. 
6. 
Arroll, B. and F. Goodyear-Smith (2005). "Corticosteroid injections for painful shoulder: a meta-analysis." 
Br J Gen Pract 55(512): 224-228. 
7. 
Yu, C. M., et al. (2006). "Subacromial injections of corticosteroids and xylocaine for painful subacromial 
impingement syndrome." Chang Gung Med J 29(5): 474-479. 
8. 
Gaujoux-Viala, C., et al. (2009). "Efficacy and safety of steroid injections for shoulder and elbow 
tendonitis: a meta-analysis of randomised controlled trials." Ann Rheum Dis 68(12): 1843-1849 
9. 
Gruson, K. I., et al. (2008). "Subacromial corticosteroid injections." J Shoulder Elbow Surg 17(1 Suppl): 
118S-130S  
10. 
van Riet, R. P., et al. (2012). "The long term effect of an intra-articular injection of corticosteroids in the 
acromioclavicular joint." J Shoulder Elbow Surg 21(3): 376-379. 
11. 
Gutierrez, G., et al. (2004). "Clinical inquiries. Does injection of steroids and lidocaine in the shoulder 
relieve bursitis?" J Fam Pract 53(6): 488-492. 
12. 
Price, R., et al. (1991). "Local injection treatment of tennis elbow--hydrocortisone, triamcinolone and 
lignocaine compared." Br J Rheumatol 30(1): 39-44. 
13. 
Stanton-Hicks, MD. Local anesthetics: Pharmacology and clinical applications. Hosp Formul 1987; 
22:156. 

ICF_000.pdf: 
 
 
 
Version Date: 2/8/2016 
Page 1 of 8 (v. 08/31/2015) 
 
 
 
CONSENT FOR RESEARCH 
Penn State College of Medicine 
The Milton S. Hershey Medical Center 
 
Title of Project:  The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections 
 
 
Principal Investigator: Dr. Robert Gallo 
 
Address: Penn State Milton S. Hershey Medical Center, Bone & Joint Institute, 30 Hope Drive, EC089, PO Box 
859, Hershey, PA  17033 
 
Telephone Numbers: Weekdays: 8:00 a.m. to 5:00 p.m. (717) 531-5638. 
After hours call (717) 531-8521. Ask for the orthopaedic doctor on 24-hour call. 
 
Subject’s Printed Name: _____________________________ 
 
We are asking you to be in a research study. 
Whether or not you take part is up to you. You can choose not to take part. You can agree to take part 
and later change your mind. Your decision will not be held against you. 
This form gives you information about the research. Please ask questions about anything that is 
unclear to you and take your time to make your choice. 
 
 
1.   Why is this research study being done?    
 
We are asking you to be in this research study because your doctor has determined that a steroid 
injection for the treatment for your shoulder pain is an appropriate intervention. 
 
This research is being done to compare pain relief and efficacy of shoulder injections using one of 
the following: 
o Group A=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine 
o Group B=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine 
after 2 ml in subcutaneous injection 
o Group C=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine 
after applying ethyl chloride spray for 3 seconds 
 
        
All steroid injections will contain lidocaine in the solution. 
 
 
The specific aim of this prospective study is to determine whether local anesthetics prior to 
steroid injections reduce pain and consequently if they are cost-effective in the treatment for 
shoulder problems. 
 
 
Approximately 150 people will take part in this research study at Hershey Medical Center.  


 
 
 
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Page 2 of 8 (v. 08/31/2015) 
 
2.   What will happen in this research study? 
       
After you have read through this consent form, all of your questions have been answered to your 
satisfaction, and you have agreed to participate by signing this form, it will be determined by reviewing your 
medical history if you meet all of the criteria to participate in the study. 
If you are eligible to be in the study, you will be randomized (assigned at random, like flipping a coin) to one 
of three study groups: 
o Group A=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine 
o Group B=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml 
in subcutaneous injection 
o Group C=Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 
applying ethyl chloride spray for 3 seconds 
 
All steroid injections will contain lidocaine in the solution. 
 
 
All treatment drugs are FDA approved and considered standard of care. 
 
 
Randomization means that neither you nor your study doctor will choose what group you will be in.  
You will have an equal (1 out of 3) chance of being placed in any one of the three groups.     The research 
coordinator will ask you to rate your current pain on a visual pain scale before the injection. Then, the study 
investigator will perform the injection of your shoulder.  Immediately after the injection is finished and ten 
minutes after the injection, you will be asked to rate your current pain using the same visual pain scale. 
 
What are my responsibilities if I take part in this research?  
If you take part in this research, your major responsibilities will include:  
• 
Completing the visual pain scale during the visit. 
• 
Allowing access to your medical records as it pertains to this study. 
 
3.   What are the risks and possible discomforts from being in this research study?   
There is a risk of loss of confidentiality if your medical information or your identity are obtained by 
someone other than the investigators, but precautions will be taken to prevent this from happening. 
The confidentiality of your electronic data created by you or by the researchers will be maintained to 
the degree permitted by the technology used. Absolute confidentiality cannot be guaranteed.  
 
You will be assigned to a treatment program by chance. The treatment you receive may prove to be less 
effective or to have more side effects than the other research treatment(s) or other available 
treatments. 
 
Ethyl Chloride - freezing may alter skin pigment. 
 
Kenalog - joint tissue damage, swelling in your veins, allergic reaction, infection, increase in blood sugar.   
 
Lidocaine - itching, rash, swelling of the skin, pain at the injection site, numbness, dizziness, and allergic 
reactions.  Rarely, when injected into the blood stream lidocaine can cause confusion, coma, seizures, 
respiratory arrest, heart beat irregularities, and toxicities; however, in this study lidocaine will not be 
injected into your bloodstream. 


 
 
 
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Page 3 of 8 (v. 08/31/2015) 
 
There is risk of some pain and discomfort with the injection as well as the possibility of nerve damage 
after the injection.  
 
4.   What are the possible benefits from being in this research study?    
4a.  What are the possible benefits to me? 
         You may or may not benefit from this particular research study. The treatment group that you are 
assigned to could be more beneficial than another in providing you pain relief.   
    
4b. What are the possible benefits to others? 
          The results of this study may guide future treatment decisions. 
 
5.   What other options are available instead of being in this research study? 
 
 
You do not have to take part in this study to be treated for your condition. Instead of participating in 
this research, you could: 
• 
Receive commercially available treatments such as a topical anesthetic . 
• 
Be part of a different research study, if one is available. 
• 
Choose not to be treated for your medical condition. 
 
Before you decide if you want to be in this research, we will discuss the other choices that are available 
to you. We will tell you about the possible benefits and risks of these choices. 
 
The therapy offered in this research is available to you without taking part in this research study.     
 
6.   How long will I take part in this research study? 
If you agree to take part, it will take you about 10 extra minutes to fill out the questionnaires for the 
study. Your participation ends with this clinic visit.  
 
7.   How will you protect my privacy and confidentiality if I decide to take part in this research study? 
 
7a.  What happens to the information collected for the research? 
Efforts will be made to limit the use and sharing of your personal research information. In our research 
files at The Milton S. Hershey Medical Center (HMC) and Penn State College of Medicine (PSU) we will 
include these identifiers:  dates, your name, medical record number, phone number, and a code 
number. 
 
• 
A list that matches your name with your code number will be kept in a locked file in Dr. Gallo’s 
research office. 
• 
Your research records will be labeled with your code number and kept in a safe area in Dr. Gallo’s 
research office. 
• 
A copy of this signed consent form will be included in your HMC medical record. This means that 
other HMC healthcare providers will know you are in this study.  
 
In the event of any publication or presentation resulting from the research, no personally identifiable 
information will be shared.  


 
 
 
Version Date: 2/8/2016 
Page 4 of 8 (v. 08/31/2015) 
 
 
7b. How will my identifiable health information be used? 
If you give your consent, health information that can be traced to you will be collected for this research 
study. In general, under federal law, health information is private. However, there are exceptions to this 
rule, and you should know who may be able to see, use, and share your health information for research 
and why they may need to do so.  
 
The research team may use the following health information: 
• 
Past, present, and future medical records 
• 
New health information from tests, procedures, visits, interviews, or forms filled out as part of this 
research study. 
The following people/groups may see, use, and share your identifiable health information: 
• 
HMC/PSU research staff involved in this study 
• 
The HMC/PSU Institutional Review Board (IRB), a group of people who review the research study to 
protect subjects’ rights and welfare 
• 
The HMC/PSU Human Subjects Protection Office 
• 
The HMC/PSU Research Quality Assurance Office 
• 
Non-research staff within HMC/PSU who need this information to do their jobs (such as for 
treatment, payment (billing), or health care operations) 
• 
Federal and state agencies (such as the U.S. Food and Drug Administration, the Office for Human 
Research Protections, the Department of Health and Human Services, the National Institutes of Health, 
and other U.S. or foreign government bodies that oversee or review research) 
• 
The HMC/PSU pharmacy 
• 
Organizations that provide independent accreditation and oversight of hospitals and research 
• 
Public health and safety authorities (for example, if we learn information that could mean harm to 
you or others, we may need to report this, as required by law) 
 
These groups may also review and/or copy your original PSU/HMC records while looking at the results 
of the research study.  It is possible that some of the other people/groups who receive your health 
information may not be required by Federal privacy laws to protect your information. We share your 
information only when we must, and we ask anyone who receives it from us to protect your privacy.  
 
Because research is an ongoing process, your permission for the use, storage and sharing of your health 
information will continue indefinitely.  
 
Your privacy rights: 
• 
You have the right to refuse to sign this form that allows us to use and share your health 
information for research; however, if you don’t sign it, you will not be able to take part in this research 
study. 
• 
You have the right to withdraw your permission for us to use or share your health information for 
this research study. If you want to withdraw your permission, you must notify the person in charge of 
this research study in writing using the address on the front of this form. Once permission is withdrawn, 
you cannot continue to take part in the study.  
• 
If you withdraw your permission, we will stop collecting health information about you for this 
study; we may continue to use and share your health information that we already have if it is necessary 


 
 
 
Version Date: 2/8/2016 
Page 5 of 8 (v. 08/31/2015) 
for safety and scientific soundness of the research study; and we will not be able to take back 
information that has already been used or shared with others.  
• 
You have the right to see and get a copy of your health information that is used or shared for 
treatment or for payment. However, you may not be allowed to see or copy certain health information 
that is a part of this research study. This is only for the period of the study. You will be allowed to see 
that information when the entire research study is complete. 
 
      
8.   What are the costs of taking part in this research study? 
8a. What will I have to pay for if I take part in this research study?  
For costs of tests and procedures that are only being done for the research study: 
• 
You and/or your insurance company will not be charged for the cost of any tests or procedures that 
are required as part of the research and are outside the standard of care (what is normally done) 
for your condition.  
• 
The research-related tests and procedures that will be provided at no cost to you include: 
completion of the visual pain scale before and after the standard of care injection. 
  
For costs of medical services for care you would receive even if you were not in this research study: 
• 
You and/or your insurance company will be responsible for the cost of routine medications, tests 
and procedures that you would receive even if you were not in this research. 
• 
You and/or your insurance company will be billed for the costs of these routine tests and 
procedures in the usual manner. 
• 
You will be responsible for any co-payments, co-insurance and deductibles that are standard for 
your insurance coverage.  
• 
You will be responsible for any charges not reimbursed by your insurance company. 
• 
Some insurance companies will not pay for routine costs for people taking part in research studies. 
Before deciding to be in this research you should check with your insurance company to find out what 
they will pay for. 
 
If you have any questions about costs and insurance, ask the research study doctor or a member of the 
research team. 
 
8b. What happens if I am injured as a result of taking part in this research study? 
It is possible that you could develop complications or injuries as a result of being in this research 
study. If you experience a side effect or injury and emergency medical treatment is required, seek 
treatment immediately at any medical facility. If you experience a side effect or injury and you 
believe that emergency treatment is not necessary, you should contact the principal investigator 
listed on the first page of this consent form as soon as possible and he/she will arrange for medical 
treatment. 
 
HMC/PSU compensation for injury 
• 
There are no plans for HMC/PSU to provide financial compensation or free medical 
treatment for research-related injury.  
• 
If an injury occurs, medical treatment is available at the usual charge.  
• 
Costs will be charged to your insurance carrier or to you.  
• 
Some insurance companies may not cover costs associated with research injuries.  
• 
If these costs are not covered by your insurance, they will be your responsibility. 


 
 
 
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Page 6 of 8 (v. 08/31/2015) 
 
When you sign this form you are not giving up any legal right to seek compensation for injury. 
 
9. Will I be paid to take part in this research study? 
You will not receive any payment or compensation for being in this research study. 
 
10. Who is paying for this research study? 
The institution and investigators are not receiving any funds to support this research study.          
 
11.  What are my rights if I take part in this research study? 
Taking part in this research study is voluntary.  
• 
You do not have to be in this research.  
• 
If you choose to be in this research, you have the right to stop at any time.  
• 
If you decide not to be in this research or if you decide to stop at a later date, there will be no 
penalty or loss of benefits to which you are entitled.  
 
If you stop being in the research, already collected data may not be removed from the study database. You 
will be asked whether the investigator can collect medical information from your routine medical care. If 
you agree, this data will be handled the same as research data. If you withdraw completely from the 
research study, no further information will be collected and your participation will end. You may 
discontinue taking part at any time without penalty or loss of benefits to which you are otherwise entitled.  
 
Your research doctor may take you out of the research study without your permission.  
• 
Some possible reasons for this are: continuing the research would be harmful, your condition has 
become worse,  you did not follow the instructions of the study doctor, you experience serious side 
effects. 
• 
If your participation ends early, you may be asked to visit the research doctor for a final visit.  
 
 
If you will be in another clinical research study at Hershey Medical Center or elsewhere while in this 
research, you should discuss the procedures and/or treatments with your physician or the study doctors. 
This precaution is to protect you from possible side effects from interactions of research drugs, treatments 
or testing. 
 
During the course of the research you will be provided with any new information that may affect your 
health, welfare or your decision to continue participating in this research. 
12. If I have questions or concerns about this research study, whom should I call?     
Please call the head of the research study, Dr. Robert Gallo at 717-531-5638  or the orthopedic 
surgery doctor on 24-hour call at 531-8521 if you: 
• 
Have questions, complaints or concerns about the research. 
• 
Believe you may have been harmed by being in the research study.   
 
You may also contact the research protection advocate in the HMC Human Subjects Protection 
Office (HSPO) at 717-531-5687 if you: 
• 
Have questions regarding your rights as a person in a research study. 
• 
Have concerns or general questions about the research.  
• 
Have questions about your privacy and the use of your personal health information.  


 
 
 
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Page 7 of 8 (v. 08/31/2015) 
• 
You may also call this number if you cannot reach the research team or wish to talk to 
someone else about any concerns related to the research.  
 
You may visit the HSPO’s web site at http://pennstatehershey.org/irb under subject information 
for: 
• 
Information about your rights when you are in a research study;  
• 
Information about the Institutional Review Board (IRB), a group of people who review the 
research to protect your rights; and  
• 
Links to the federal regulations and information about the protection of people who are in 
research studies. If you do not have access to the internet, copies of these federal 
regulations are available by calling the HSPO at (717) 531-5687. 
 
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. 
 
INFORMED CONSENT AND AUTHORIZATION TO TAKE PART IN RESEARCH  
 
Signature of Person Obtaining Informed Consent 
 
Your signature below means that you have explained the research to the subject or subject 
representative and have answered any questions he/she has about the research. 
 
______________________________ 
 
_________ 
______ __________ 
Signature of person who explained this research Date 
 
Time 
              Printed Name 
 
(Only approved investigators for this research may explain the research and obtain informed consent.)   
 
Signature of Person Giving Informed Consent and Authorization 
Before making the decision about being in this research you should have: 
• 
Discussed this research study with an investigator,  
• 
Read the information in this form, and 
• 
Had the opportunity to ask any questions you may have.  
Your signature below means that you have received this information, have asked the questions you 
currently have about the research and those questions have been answered. You will receive a copy of the 
signed and dated form to keep for future reference. 
 
Signature of Subject 
 
By signing this consent form, you indicate that you voluntarily choose to be in this research and agree to 
allow your information to be used and shared as described above.  
 
___________________________ 
__________ 
______       
________________  
Signature of Subject  
 
 
Date 
 
Time 
 
Printed Name 
 
 
 
 


 
 
 
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