Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity
Conditions: Shoulder Pain, Pain
Sponsor: St. Luke's Hospital and Health Network, Pennsylvania

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title: Shoulder Symptom Irritability Scale: A Single-Blinded Observational 
Study (SSIS) 
 
Identifier: NCT02995941 
 
Date of Document: October 31, 2016 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          2 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61  
 
 
Version Number:1 
Version Date:6/29/2016 
STUDY PROTOCOL with SAP & ICF 
1 
 
2 
Section A: Experimental Design 
3 
This study will employ a quasi-experimental design utilizing repeated measures (specific 
4 
aim 1), followed by cross-sectional analysis (specific aims 2 and 3). The target sample size for 
5 
the study will be 25 physical therapists and 90 patients. Patient-reported outcome measures were 
6 
selected based upon their reliability, validity and internationally accepted use. Given that there is 
7 
no single universal patient reported outcome measure for the shoulder, multiple measures will be 
8 
utilized during the third aim of this project. 
9 
Specific Aim 1 
10 
The first specific aim will be to determine the reliability of the shoulder symptom 
11 
irritability classification scale. To address this aim, the project will analyze paired rater 
12 
judgments of shoulder symptom irritability (high, moderate or low) from 90 patients with 
13 
shoulder pain. Raters will be physical therapists from multiple clinics trained in rating shoulder 
14 
symptom irritability. Prevalence-adjusted, bias-adjusted Kappa for ordinal scales (PABAK-OS)1 
15 
will be the primary measure of reliability. However, analysis may be adjusted based on the data 
16 
distribution. 
17 
Specific Aim 2 
18 
The second aim is to compare level of functional limitation between shoulder symptom 
19 
irritability groups. To address this aim, the project will analyze patient-reported functional 
20 
measures using analysis of variance with post-hoc analysis to compare functional disability 
21 
across different levels of shoulder symptom irritability. The independent variable will be the 
22 
shoulder symptom irritability level, and dependent variables will include patient-reported 
23 
functional status measures. The hypothesis is that patients with higher irritability will report 
24 
greater functional deficits. 
25 
Specific Aim 3 
26 
The final specific aim is to determine if the level of shoulder symptom irritability dictates 
27 
the chosen intervention intensity. To address this aim, raters will select planned intervention 
28 
choices for each of the 90 patients, utilizing a pre-specified list of possible physical therapy 
29 
interventions. Data analysis will include PABAK-OS for correlation, and independent t-test for 
30 
differences between clinical specialist and non-specialist groups. The hypothesis is that patients 
31 
with high irritability will be prescribed interventions aimed at minimizing the physical stress to 
32 
the affected tissue(s), while patients with low irritability will be prescribed interventions at a 
33 
higher intensity to address the physical impairments. 
34 
Section B: Subjects 
35 
1. Number of subjects 
36 
 
Raters will be recruited from outpatient physical therapists in the St. Luke’s 
37 
University Health Network with an expected response of 25. Patient subjects will be 
38 
recruited from a convenience sample of consecutive patients presenting for physical 
39 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          3 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61  
 
 
Version Number:1 
Version Date:6/29/2016 
therapy consultation for shoulder pain. Expected patient sample size is 90 subjects over a 
40 
6-month period. As pilot data has demonstrated K>0.85 with similar methodology,2 this 
41 
study is powered at 80% to determine a K>0.80 with a sample size of 48 with a null K 
42 
value of 0.40.3 However, due to the expected restriction of subjects in phases 2 and 3 of 
43 
this study (to only those subjects with 100% agreement between raters to maintain the 
44 
integrity of internal validity), doubling the required sample size is prudent to maintain 
45 
power of the subsequent analyses. 
46 
2. Criteria for inclusion/exclusion 
47 
Rater Group 
48 
 
Inclusion criteria will be state licensure as a physical therapist and regular 
49 
clinical practice with patients with shoulder disorders, defined as a minimum of 500 
50 
clinical hours per year in an orthopaedic setting with >10% of patients with shoulder 
51 
disorders. Exclusion criteria will include not meeting inclusion criteria. 
52 
Patient Group 
53 
 
Inclusion criteria will be presenting with a chief complaint of shoulder pain, not 
54 
extending to the neck, for outpatient physical therapy consultation.  Exclusion criteria 
55 
will include illiteracy in English and age less than 18 years. Additionally, subjects will be 
56 
excluded from the study if they present with pain or symptoms distal to elbow, have had 
57 
shoulder surgery on the symptomatic side in the past year, if active or passive cervical 
58 
spine ROM reproduces shoulder pain, have a positive Spurling’s test, or if they are 
59 
unable to complete the patient reported functional questionnaires. Subjects found to have 
60 
need for referral to another medical professional will be provided with the appropriate 
61 
referral. If the reason for referral would prevent them from participating safely in the 
62 
study, that subject will be excluded from testing. 
63 
 
64 
3. Institutional Review Board (IRB) approval 
65 
 
Ethics approval has been obtained from the Institutional Review Boards of St. 
66 
Luke’s University Health Network (SLHN 2016-61) and Nova Southeastern University 
67 
(2016-379). Written informed consent will be obtained from each subject prior to 
68 
enrollment. 
69 
Section C: Methods and Instrumentation 
70 
Instrumentation 
71 
Demographic information questionnaire 
72 
The survey will collect demographic data from raters including name, age, years 
73 
of practice, advanced certification(s), gender, entry-level degree, and highest earned 
74 
degree. 
75 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          4 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61  
 
 
Version Number:1 
Version Date:6/29/2016 
Shoulder Symptom Irritability Classification Scale 
76 
Raters will classify patient subjects in one of three shoulder symptom irritability 
77 
levels based upon: pain level, presence of night or resting pain, onset of pain during 
78 
motion, differences between active and passive range of motion, and level of disability.4-6 
79 
Patient-Reported Outcome Scales 
80 
Three patient-rated outcome scales will be administered for the purpose of 
81 
enhancing generalizability, as there is no single gold standard patient-reported outcome 
82 
scale for patients with shoulder pain.7,8 
83 
Focus On Therapeutic Outcomes (FOTO) 
84 
The FOTO scale9 is a computerized adaptive test (CAT) and will be 
85 
administered via iPad (iPad 2, Apple, Cupertino, CA) at each St. Luke’s Physical 
86 
Therapy clinic. The FOTO scale has been found to be a reliable and valid 
87 
measurement system for outpatient orthopedic rehabilitation,9-11 and has 
88 
demonstrated good construct validity and responsiveness for patients with 
89 
shoulder complaints.12,13 The FOTO questionnaire has a low burden on patients, 
90 
with a mean test administration time of 1 minute and 29 seconds (SD = 90 
91 
seconds).12 Furthermore, the standard error of the mean (SEM) has been found to 
92 
be 1.30 with a minimal detectable change with 95% confidence (MDC95) of 3.60-
93 
10.88 functional score units.12,13 Additionally, FOTO will be utilized to collect 
94 
demographic data for each patient including comorbidities, age, gender, height, 
95 
weight, chronicity of symptoms, type of insurance used, level of fear avoidance, 
96 
and number of surgeries. 
97 
Penn Shoulder Score (PSS) 
98 
The Penn Shoulder Score (PSS), originally published in 199914 and 
99 
validated in 2006,15 is a self-report questionnaire consisting of three sections: 
100 
pain, satisfaction, and function. The function subscale consists of twenty (20) 
101 
items, each on a 4-point Likert scale. Each item is scored as 0 (can’t do at all), 1 
102 
(much difficulty), 2 (with some difficulty), or 3 (no difficulty). The item scores 
103 
are then summed to determine the subscale score out of 60 (no difficulty for all 
104 
items). Resultant scores for each subscale are divided by the total range from 0-
105 
100 with 0 as greatest disability and 100 as no disability.14 The PSS has 
106 
demonstrated good test-retest reliability (ICC2,1 = 0.94) with a SEM90 of 8.5.15 
107 
The MDC90 is 12.1, and the minimal clinically important difference (MCID) was 
108 
found to be 11.4.15 
109 
American Shoulder and Elbow Surgeons (ASES) Shoulder Score 
110 
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score, 
111 
originally published in 199416 and validated in 2002,17 is a self-report 
112 
questionnaire consisting of two sections: one visual analog scale (VAS) to 
113 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          5 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61  
 
 
Version Number:1 
Version Date:6/29/2016 
measure pain, and ten items to measure activities of daily living. The 
114 
questionnaire takes 3 minutes to complete and is scored as follows: [(10 – VAS 
115 
pain) x 5] + (5/3 x sum of ADL items).18 Resultant scores for each subscale range 
116 
from 0-100 with 0 as greatest disability and 100 as no disability.18 The ASES has 
117 
demonstrated good to excellent test-retest reliability (ICC = 0.61-0.96) with an 
118 
SEM of 6.7.18 The MDC95 is 11.2,17 and the MCID was found to be 12.0.19 A 
119 
recent systematic review found the ASES to be one of the only patient-reported 
120 
functional scales for rotator cuff disease to have measurement error below 10% of 
121 
the global score.20 
122 
Numeric Pain Rating Scale 
123 
The Numeric Pain Rating Scale (NPRS) is an 11-point Likert scale that can be 
124 
used to measure pain intensity. The NPRS is a standard pain assessment scale that uses a 
125 
0-10 scale (no pain to worst pain imaginable, respectively) in order to determine a 
126 
patient’s level of pain. Patients rate their current level of pain and their worst and least 
127 
amount of pain in the last 24 hours. The average of the 3 ratings is used to represent the 
128 
patient’s level of pain. The NPRS has demonstrated good reliability (ICC2,1=0.74)and 
129 
responsiveness (MDC = 2.5, MCID = 1.1) in subjects with shoulder pain21 and excellent 
130 
reliability in an upper extremity orthopaedic population.22 Furthermore, the NPRS has 
131 
been used to assess pain severity of both traumatic and atraumatic etiologies.23 
132 
Range of Motion 
133 
Goniometric measurements of shoulder AROM in symptomatic patients 
134 
demonstrates fair-good reliability with regards to intra- and inter-rater reliability (Inter-
135 
rater Rho = 0.64-0.80; Intra-rater Rho = 0.53-0.91).24-27 Passive range of motion (PROM) 
136 
demonstrates even greater reliability with intra-examiner ICC values = 0.98, and inter-
137 
examiner ICC values ranging from 0.87-0.89.25 
138 
End Feel - Pain 
139 
The ability to utilize end feel to determine sequence of pain in relation to tissue 
140 
resistance has generally shown good intra-rater reliability (Κ = 0.48 to 0.59,28 Κw = 0.59 
141 
to 0.8729) and is frequently used for clinical decision-making.29 
142 
Procedures 
143 
At least 2 raters will be recruited from each site. Raters will be trained with the following 
144 
materials: (1) Collaborative Institutional Training Initiative (CITI) training for those involved in 
145 
consenting the patients; (2) the reading of the Staged Approach for Rehabilitation Classification: 
146 
Shoulder Disorders6 with direction to pay special attention to the section on Level 3 
147 
classification and Table 3;6(pp 795-6) and (3) a short online narrated presentation to reinforce 
148 
understanding of the content. The intent of this training method is to increase the generalizability 
149 
of the study results, and to avoid overly specialized training methods that would be difficult to 
150 
reproduce clinically. 
151 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          6 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61  
 
 
Version Number:1 
Version Date:6/29/2016 
Patients will be recruited by the raters from their regular caseload (Appendix C). Patients 
152 
will receive a brief explanation about the study, provide informed consent, and be asked to 
153 
complete the functional questionnaires as part of the outpatient admissions process. The first 
154 
therapist will rate the patient’s shoulder symptom irritability level during the normal examination 
155 
process utilizing the intake (Appendix C). Raters will inquire on the presence of night or resting 
156 
pain and complete a physical examination including measurement of active and passive shoulder 
157 
flexion.  Range of motion measurements will be utilized for direct comparison and to determine 
158 
the onset of pain during passive motion.  Shoulder flexion will be measured utilizing goniometric 
159 
procedures described elsewhere.24,25  Active range of motion testing will be performed in 
160 
standing and passive range of motion testing will be performed in supine.    
161 
After the first rater has completed their examination and prior to any intervention that 
162 
may change the shoulder symptom irritability, a second rater, blinded from the first rater’s 
163 
assessment, will then examine and rate the subject (Appendix C). In addition to the shoulder 
164 
symptom irritability rating, both raters will also be asked to provide a treatment intensity 
165 
recommendation based upon the examination findings (Appendix C). Data collection forms will 
166 
be placed in a sealed envelope and sent via interoffice mail for analysis.  To maintain rater 
167 
blinding, raters will be asked to not discuss ratings until data collection is complete.   
168 
Data Collection and Storage 
169 
Data will be collected for a period of 6 months. All data will be kept on a secure, 
170 
password-protected server (RedCap, Nashville, TN; https://redcap.slhn.org/). 
171 
Section D: Statistical Analysis 
172 
Descriptive statistics will be used to characterize both raters and patients. Frequencies 
173 
will be utilized for categorical variables, and means with standard deviations for continuous 
174 
variables. 
175 
A repeated measures design, utilizing two raters per subject, will be utilized to determine 
176 
inter-rater reliability. The raters will independently rate the subject’s shoulder symptom 
177 
irritability level utilizing the recently developed shoulder symptom irritability scale.4,6 The inter-
178 
rater reliability will be evaluated using the PABAK-OS statistic.1,3 For evaluation of statistical 
179 
significance, a two-tailed confidence interval will be utilized with α set to 0.05, and the null 
180 
hypothesis will be that the PABAK-OS will be <0.40.3 
181 
Analysis of variance with post-hoc analysis will be utilized for evaluation of differences 
182 
in patient reported functional limitation and pain subscales between shoulder symptom 
183 
irritability groups. For evaluation of statistical significance, α will be set to 0.05. 
184 
Lastly, to evaluate correlation between intervention intensity and diagnosed level of 
185 
shoulder symptom irritability, the PABAK-OS statistic will be used. Additionally, independent t-
186 
tests will be utilized to evaluate for difference between groups for hypotheses 1 and 2 of aim 3. 
187 
For evaluation of statistical significance, α will be set to 0.05. 
188 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          7 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61  
 
 
Version Number:1 
Version Date:6/29/2016 
Section E: Limitations and Potential Problems 
189 
One potential problem is the need to have more than one clinician trained and available to 
190 
rate the subjects at all times.  Many clinics in this regional hospital network have fewer than 
191 
three physical therapists and thus, there will be a risk of potential subject loss during the 
192 
reliability phase.  I intend to address this barrier via incentives derived from grant application 
193 
and via administrative support as the hospital network has a defined educational and research 
194 
vision.   
195 
A limitation to this study is the use of physical therapists and consecutive patients from a 
196 
single regional hospital network.  However, the regional hospital network encompasses over 30 
197 
locations with over 80 physical therapists, 18 of which are clinical specialists. Furthermore, the 
198 
need to have more than one clinician trained and available to rate the subjects at all times could 
199 
potentially lead to subject loss during the reliability phase.   
200 
Another limitation of this study would be the limitation of data in aim 3 to only those 
201 
subjects who had complete agreement between raters.  This would potentially reduce the power 
202 
of this part of the study.  However, the risk to internal validity by utilizing the subjects without 
203 
complete agreement would be a greater threat to the study than the limitation of power to aim 3 
204 
and, to minimize the effect of this limitation, sample size will be twice the size needed to power 
205 
the study at 80%.  
206 
Additionally, the FOTO functional status instrument is a proprietary measure, and while 
207 
it is utilized nationally and internationally, it is not likely that it will be universally used due to 
208 
its proprietary nature, thus limiting the generalizability of that aspect of the study.  Finally, the 
209 
data obtained regarding clinician outcome trends is retrospective rather than prospective.  While 
210 
longitudinal data would be ideal, the aim of utilizing retrospective data is to determine if further 
211 
investigation utilizing longitudinal data is necessary, given the time and financial implications of 
212 
such a study.   
 
213 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          8 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61  
 
 
Version Number:1 
Version Date:6/29/2016 
APPENDIX A: IRB INFORMED CONSENT - SUBJECTS 
214 
 
215 
St. Luke’s University Health Network 
216 
Informed Consent Document for Human Subjects Research 
217 
 
218 
Department: Physical Therapy at St. Luke’s 
219 
 
220 
Principal Investigator: Stephen Kareha, DPT 
 
 
Telephone: 484-426-2544 
221 
 
222 
Co-investigator: Alicia Fernandez-Fernandez, DPT, PhD  
Telephone: 954-262-1653 
223 
 
224 
Co-investigator: Philip McClure, PT, PhD  
 
 
Telephone: 215-572-2863 
225 
 
226 
Medical Study Title: Shoulder Symptom Irritability: A Single-Blinded Observational Study 
227 
 
228 
Lay Study Title: Shoulder Symptom Irritability Testing 
229 
 
230 
Sponsor: None 
231 
 
232 
 
233 
What Is Informed Consent? 
234 
 
235 
You are being asked to take part in a medical research study. As required by federal regulations, 
236 
this research study has been reviewed and approved by an Institutional Review Board (IRB), a 
237 
committee that reviews, approves and monitors research involving humans. Before you can make 
238 
a decision about whether to participate, you should understand the possible risks and benefits 
239 
related to this study. This process of learning and thinking about a study before you make a 
240 
decision is known as informed consent and includes: 
241 
 Receiving detailed information about this research study; 
242 
 Being asked to read, sign and date this consent form, once you understand the study and 
243 
have decided to participate. If you don’t understand something about the study or if you 
244 
have questions, you should ask for an explanation before signing this form; 
245 
 Being given a copy of the signed and dated consent form to keep for your own records. 
246 
 
247 
What is the purpose of this study?  
248 
 
249 
Shoulder pain is a large medical and economic problem. Each person that is treated for shoulder 
250 
pain has a unique case, however, research is continually being performed to try to help medical 
251 
providers better treat these patients. One way we are trying to enhance this is by developing a 
252 
tool for classifying the level of “shoulder symptom irritability,” or pain and dysfunction levels, 
253 
of patients with shoulder pain. This study is looking at the reliability (or accuracy) and use of this 
254 
irritability scale between many different physical therapists. 
255 
 
256 
How many individuals will participate in the study and how long will the study last? 
257 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          9 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61  
 
 
Version Number:1 
Version Date:6/29/2016 
 
258 
90 patients will participate at St. Luke’s University Health Network. Your involvement in the 
259 
study will last about 1 day.   
260 
 
261 
What will I have to do during the study?   
262 
 
263 
Whether or not you choose to participate, your treatment and care will not change or be affected. 
264 
Your physical therapist will still examine, evaluate, and treat you as they would regardless of 
265 
participation in the study. Your involvement includes: answering your therapists questions in 
266 
regards to pain levels, filling out a functional activity questionnaire, and discussing your 
267 
condition with your physical therapist. 
268 
 
269 
What are the risks or discomforts involved?  
270 
 
271 
There are no side effects or risks for participating in the study and, as stated before, your 
272 
treatment will not differ whether you choose to participate in the study or not. 
273 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          10 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
 
274 
Are there alternatives to being in the study? 
275 
 
276 
You do not have to participate in this study.  
277 
 
278 
HIPAA Authorization: How will privacy and confidentiality (identity) be protected? 
279 
 
280 
Federal regulations require that certain information about individuals be kept confidential. This 
281 
information is called “protected health information” (PHI). PHI includes information that 
282 
identifies you personally such as name, address and social security number, or any medical or 
283 
mental health record, or test result, that may have this sort of information on it. The laws state 
284 
that you may see and review your St. Luke’s University Health Network medical records at any 
285 
time. However, in a research study, you may not see the study results or other data about the 
286 
study until after the research is completed unless the study doctor decides otherwise. 
287 
 
288 
If you join this study, the following individuals or entities may have access to your PHI and by 
289 
law must protect it.  These include investigators listed on this consent form and other personnel 
290 
of St. Luke’s University Health Network involved in this specific study, including the 
291 
Institutional Review Board (IRB), and your health insurance company (if necessary for billing 
292 
for standard medical care). It may also be provided to other people or groups as follows:  
293 
 
294 
 
Researchers at Arcadia University 
295 
 
Researchers at Nova Southeastern University  
296 
 
297 
Your PHI may also be shared with the following entities that, while not obligated by law to 
298 
protect PHI, will protect it to the best of their ability:  
299 
 
300 
 With any person or agency required by law.  
301 
 
302 
 
303 
The following information will be provided to the study sponsor and other entities noted above: 
304 
 
305 
Study data for analysis: Questionnaire results and physical examination results 
306 
Demographic data: None 
307 
 
308 
If you develop an illness or injury during the course of your participation in this study, other PHI 
309 
about treating and following the condition may be generated and disclosed as it relates to this 
310 
study. Your PHI may be used/disclosed until the end of the research study.   
311 
 
312 
You may quit the study and revoke permission to use and share your PHI at any time by 
313 
contacting the principal investigator, in writing, at: Dr. Stephen Kareha, 501 Cetronia Rd., Suite 145, 
314 
Allentown, PA 18104. If you quit the study further collection of PHI will be stopped, but PHI that 
315 
has already been collected may still be used. 
316 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          11 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
 
317 
The results of clinical tests and procedures performed as part of this research may be included in 
318 
your medical records. The information from this study may be published in scientific journals or 
319 
presented at scientific meetings but you will not be personally identified in these publications and 
320 
presentations. 
321 
 
322 
After your information is shared with others, like the sponsor, it may no longer be protected by 
323 
the Privacy Rule. The people who receive this information could use it in ways not discussed in 
324 
this form and could disclose it to others. The sponsor will use and disclose information about you 
325 
only for research or regulatory purposes or to prepare research publications. In addition to using 
326 
it for this study, the sponsor may reanalyze the study data at a later date or combine your 
327 
information with information from other studies for research purposes not directly related to this 
328 
study. When using the information in these ways, the sponsor may share it with other 
329 
researchers, its business partners, or companies hired to provide research-related services. 
330 
However, your name will never appear in any sponsor forms, reports, databases, or publications, 
331 
or in any future disclosures by the sponsor. 
332 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
333 
by U.S. Law. This Web site will not include information that can identify you. At most, this Web 
334 
site will include a summary of the results. You can search this Web site at any time. 
335 
 
336 
Will I benefit from being in this study?  
337 
 
338 
You may not benefit from being in this research, but we hope that what we learn may be helpful 
339 
to future patients or society in general. 
340 
 
341 
Will I be paid for being in this study? 
342 
 
343 
You will not receive payment for your participation in this study.   
344 
 
345 
In addition, you will not be paid if inventions and/or patents are developed from the study 
346 
results. 
347 
 
348 
Will I be told about any new findings?  
349 
 
350 
Anything learned during the study, beneficial or not, that may affect your health or your 
351 
willingness to continue in the study, will be told to you and explained.  
352 
 
353 
Are there costs related to being in this study? 
354 
 
355 
There are no costs associated with being in this study beyond normal physical therapy care. 
356 
 
357 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          12 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
Can I be removed from the study or quit the study? 
358 
 
359 
Your decision to participate in this research study is entirely voluntary. You have been told what 
360 
being in this study will involve, including the possible risks and benefits.  
361 
 
362 
Your participation in this research project may be terminated by the study doctor without your 
363 
consent for any reason that he/she feels is appropriate or if your pain is not primarily coming 
364 
from your shoulder. 
365 
 
366 
You may refuse to participate in this investigation or withdraw consent and quit this study 
367 
without penalty and without affecting your ability to receive medical care at St. Luke’s 
368 
University Health Network. 
369 
 
370 
If you withdraw from this study, you may continue treatment with your St. Luke’s University 
371 
Health Network doctor, or you may seek treatment from another doctor of your choice. 
372 
 
373 
Should you decide to withdraw from the study, please be sure to inform the study doctor. 
374 
Additional tests or procedures may be needed to ensure your safety.  The study doctor will 
375 
explain why these tests or procedures are necessary. 
376 
 
377 
 
378 
CONTACT INFORMATION 
379 
 
380 
Telephone number for 
questions about your rights as 
a research participant 
St. Luke’s University Health 
Network Institutional Review 
Board 
484-526-6742 
For questions, concerns or 
complaints about the research, 
or if you suspect a research-
related injury 
The Principal Investigator, 
Dr. Stephen Kareha 
listed at the beginning of this 
form 
 
484-426-2544 
381 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          13 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
By your agreement to participate in this study, and by signing this consent form, you are 
382 
not waiving any of your legal rights. 
383 
 
384 
You affirm that you have read this consent form, and have been told that you will receive a 
385 
copy. 
386 
 
387 
You also authorize the use and disclosure of your health information to the parties listed in 
388 
the HIPAA authorization section of this consent for the purposes as described. 
389 
 
390 
 
391 
 
392 
 
 
 
 
 
 
 
 
 
393 
Your Name (please print or type) 
 
 
 
 
394 
 
395 
 
396 
 
 
 
 
 
____________ 
 
 
397 
Your Signature 
 
 
Date 
 
 
 
 
398 
 
399 
 
400 
 
 
 
 
 
 
401 
Name of Person Conducting   
 
402 
Consent 
 
 
 
403 
 
404 
 
405 
 
 
 
 
 
_____________ 
406 
Signature of Person Conducting  
Date 
407 
Consent 
 
408 
 
409 
 
410 
 
 
411 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          14 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
APPENDIX B: IRB INFORMED CONSENT - RATERS 
412 
 
413 
 
 
St. Luke’s University Health Network 
414 
Informed Consent Document for Human Subjects Research 
415 
 
416 
Department: Physical Therapy at St. Luke’s 
417 
 
418 
Principal Investigator: Stephen Kareha, DPT 
 
 
Telephone: 484-426-2544 
419 
 
420 
Co-investigator: Alicia Fernandez-Fernandez, DPT, PhD  
Telephone: 954-262-1653 
421 
 
422 
Co-investigator: Philip McClure, PT, PhD  
 
 
Telephone: 215-572-2863 
423 
 
424 
Medical Study Title: Shoulder Symptom Irritability: A Single-Blinded Observational Study 
425 
 
426 
Lay Study Title: Shoulder Symptom Irritability Testing 
427 
 
428 
Sponsor: None 
429 
 
430 
 
431 
What Is Informed Consent? 
432 
 
433 
You are being asked to take part in a medical research study. As required by federal regulations, 
434 
this research study has been reviewed and approved by an Institutional Review Board (IRB), a 
435 
committee that reviews, approves and monitors research involving humans. Before you can make 
436 
a decision about whether to participate, you should understand the possible risks and benefits 
437 
related to this study. This process of learning and thinking about a study before you make a 
438 
decision is known as informed consent and includes: 
439 
 Receiving detailed information about this research study; 
440 
 Being asked to read, sign and date this consent form, once you understand the study and 
441 
have decided to participate. If you don’t understand something about the study or if you 
442 
have questions, you should ask for an explanation before signing this form; 
443 
 Being given a copy of the signed and dated consent form to keep for your own records. 
444 
 
445 
What is the purpose of this study?  
446 
 
447 
Shoulder pain is a large medical and economic problem. Each person that is treated for shoulder 
448 
pain has a unique case, however, research is continually being performed to try to help medical 
449 
providers better treat these patients. One way we are trying to enhance this is by developing a 
450 
tool for classifying the level of “shoulder symptom irritability,” or pain and dysfunction levels, 
451 
of patients with shoulder pain. This study is looking at the reliability (or accuracy) and use of this 
452 
irritability scale between many different physical therapists. 
453 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          15 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
 
454 
How many individuals will participate in the study and how long will the study last? 
455 
 
456 
25 raters will participate at St. Luke’s University Health Network. Your involvement in the study 
457 
will last about 6 months.   
458 
 
459 
What will I have to do during the study?   
460 
 
461 
Whether or not you choose to participate, your employment and eligibility for promotion will not 
462 
change or be affected. Your involvement includes: reading of the Staged Approach for 
463 
Rehabilitation Classification: Shoulder Disorders with special focus on the section regarding 
464 
Level 3 classification and Table 3, a short online narrated presentation to reinforce understanding 
465 
of the content, and completing rating forms for patients with shoulder pain. 
466 
 
467 
What are the risks or discomforts involved?  
468 
 
469 
There are no side effects or risks for participating in the study and, as stated before, your 
470 
employment and eligibility for promotion will not differ whether you choose to participate in the 
471 
study or not. 
472 
 
473 
Are there alternatives to being in the study? 
474 
 
475 
You do not have to participate in this study.  
476 
 
477 
HIPAA Authorization: How will privacy and confidentiality (identity) be protected? 
478 
 
479 
Federal regulations require that certain information about individuals be kept confidential. This 
480 
information is called “protected health information” (PHI). PHI includes information that 
481 
identifies you personally such as name, address and social security number, or any medical or 
482 
mental health record, or test result, that may have this sort of information on it. The laws state 
483 
that you may see and review your St. Luke’s University Health Network medical records at any 
484 
time. However, in a research study, you may not see the study results or other data about the 
485 
study until after the research is completed unless the study doctor decides otherwise. 
486 
 
487 
If you join this study, the following individuals or entities may have access to your PHI and by 
488 
law must protect it.  These include investigators listed on this consent form and other personnel 
489 
of St. Luke’s University Health Network involved in this specific study, including the 
490 
Institutional Review Board (IRB), and your health insurance company (if necessary for billing 
491 
for standard medical care). It may also be provided to other people or groups as follows:  
492 
 
493 
 
Researchers at Arcadia University 
494 
 
Researchers at Nova Southeastern University  
495 
 
496 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          16 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
Your PHI may also be shared with the following entities that, while not obligated by law to 
497 
protect PHI, will protect it to the best of their ability:  
498 
 
499 
 With any person or agency required by law.  
500 
 
501 
 
502 
The following information will be provided to the study sponsor and other entities noted above: 
503 
 
504 
Study data for analysis: Questionnaire results and physical examination results 
505 
Demographic data: None 
506 
 
507 
If you develop an illness or injury during the course of your participation in this study, other PHI 
508 
about treating and following the condition may be generated and disclosed as it relates to this 
509 
study. Your PHI may be used/disclosed until the end of the research study.   
510 
 
511 
You may quit the study and revoke permission to use and share your PHI at any time by 
512 
contacting the principal investigator, in writing, at: Dr. Stephen Kareha, 501 Cetronia Rd., Suite 145, 
513 
Allentown, PA 18104. If you quit the study further collection of PHI will be stopped, but PHI that 
514 
has already been collected may still be used. 
515 
 
516 
The results of clinical tests and procedures performed as part of this research may be included in 
517 
your medical records. The information from this study may be published in scientific journals or 
518 
presented at scientific meetings but you will not be personally identified in these publications and 
519 
presentations. 
520 
 
521 
After your information is shared with others, like the sponsor, it may no longer be protected by 
522 
the Privacy Rule. The people who receive this information could use it in ways not discussed in 
523 
this form and could disclose it to others. The sponsor will use and disclose information about you 
524 
only for research or regulatory purposes or to prepare research publications. In addition to using 
525 
it for this study, the sponsor may reanalyze the study data at a later date or combine your 
526 
information with information from other studies for research purposes not directly related to this 
527 
study. When using the information in these ways, the sponsor may share it with other 
528 
researchers, its business partners, or companies hired to provide research-related services. 
529 
However, your name will never appear in any sponsor forms, reports, databases, or publications, 
530 
or in any future disclosures by the sponsor. 
531 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
532 
by U.S. Law. This Web site will not include information that can identify you. At most, this Web 
533 
site will include a summary of the results. You can search this Web site at any time. 
534 
 
535 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          17 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
Will I benefit from being in this study?  
536 
 
537 
You may not benefit from being in this research, but we hope that what we learn may be helpful 
538 
to future patients or society in general. 
539 
 
540 
Will I be paid for being in this study? 
541 
 
542 
You will receive payment for your participation in this study.  You will receive a $5 gift 
543 
certificate for each patient you rate in this study.  Should study payments meet or exceed $600 in 
544 
one calendar year, you will be issued a 1099 Form to report study payments as taxable income as 
545 
required by the IRS. We do not foresee your participation falling under the reportable income 
546 
parameters as there are only a total of 90 study subjects being enrolled, thus the maximum you 
547 
will be paid for your participation is $450.  
548 
 
549 
 
550 
In addition, you will not be paid if inventions and/or patents are developed from the study 
551 
results. 
552 
 
553 
Will I be told about any new findings?  
554 
 
555 
Anything learned during the study, beneficial or not, that may affect your health or your 
556 
willingness to continue in the study, will be told to you and explained.  
557 
 
558 
Are there costs related to being in this study? 
559 
 
560 
There are no costs associated with being in this study beyond normal physical therapy practice. 
561 
 
562 
Can I be removed from the study or quit the study? 
563 
 
564 
Your decision to participate in this research study is entirely voluntary. You have been told what 
565 
being in this study will involve, including the possible risks and benefits.  
566 
 
567 
Your participation in this research project may be terminated by the study doctor without your 
568 
consent for any reason that he/she feels is appropriate or if your pain is not primarily coming 
569 
from your shoulder. 
570 
 
571 
You may refuse to participate in this investigation or withdraw consent and quit this study 
572 
without penalty and without affecting your ability to receive medical care at St. Luke’s 
573 
University Health Network. 
574 
 
575 
If you withdraw from this study, you may continue treatment with your St. Luke’s University 
576 
Health Network doctor, or you may seek treatment from another doctor of your choice. 
577 
 
578 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          18 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
Should you decide to withdraw from the study, please be sure to inform the study doctor. 
579 
Additional tests or procedures may be needed to ensure your safety.  The study doctor will 
580 
explain why these tests or procedures are necessary. 
581 
 
582 
 
583 
CONTACT INFORMATION 
584 
 
585 
Telephone number for 
questions about your rights as 
a research participant 
St. Luke’s University Health 
Network Institutional Review 
Board 
484-526-6742 
For questions, concerns or 
complaints about the research, 
or if you suspect a research-
related injury 
The Principal Investigator, 
Dr. Stephen Kareha 
listed at the beginning of this 
form 
 
484-426-2544 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          19 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
Version Number:1 
Version Date:6/29/2016 
 
By your agreement to participate in this study, and by signing this consent form, you are 
not waiving any of your legal rights. 
 
You affirm that you have read this consent form, and have been told that you will receive a 
copy. 
 
You also authorize the use and disclosure of your health information to the parties listed in 
the HIPAA authorization section of this consent for the purposes as described. 
 
 
 
 
 
 
 
 
 
 
 
 
Your Name (please print or type) 
 
 
 
 
 
 
 
 
 
 
 
____________ 
 
 
Your Signature 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
Name of Person Conducting   
 
Consent 
 
 
 
 
 
 
 
 
 
 
_____________ 
Signature of Person Conducting  
Date 
Consent 
 
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          20 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
APPENDIX C: SURVEYS AND DATA COLLECTION FORMS 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          21 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          22 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
  
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          23 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          24 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          25 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          26 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          27 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
  
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          28 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          29 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61 
 
 
 

St. Luke’s University Health Network 
 
 
 
 
 
 
 
 
Kareha 
Stephen Kareha 
 
 
 
 
 
 
 
 
 
 
          30 
Director, Orthopaedic Physical Therapy Residency 
484-426-2544 
IRB Control #: 2016-61