Clinical trial NCT04216017
Conditions: Humeral Fractures
Sponsor: University of Washington
Start date: 2020-01-01; Completion date: 2022-05-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.

Detailed description:
THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.

Arms: arm 1: Patients receiving lidocaine arm 2: Patients receiving Kenalog
Interventions: intervention 1: kenalog intervention 2: Lidocaine
Intervention descriptions: intervention 1: Cortisone injection into shoulder intervention 2: Lidocaine injection into shoulder

Protocol documents:
ICF_001.pdf: 
Glenohumeral Cortisone Injection 
NCT04216017 
Jonah Hebert-Davies 
Consent Form 
10/11/2019 
 
 


UNIVERSITY OF WASHINGTON 
CONSENT FORM 
A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Triamcinolone 
(Cortisone) Injection in Patients with Shoulder Stiffness following Proximal Humerus 
Fractures  
 
Researchers: Jonah Hebert Davies Assistant Professor Orthopedics 206.744.3466 
 
 
 
Julie Agel Research Coordinator Orthopedics 206.744.4113 
24-hour emergency telephone number Investigator Call 206.744.3000 
We are asking you to be in a research study.  This form gives you information to help you 
decide whether or not to be in the study. Being in the study is voluntary. Please read this 
carefully.  You may ask any questions about the study. Then you can decide whether or not you 
want to be in the study. 
PURPOSE OF THE STUDY 
After breaking the top of your upper arm bone some patients develop shoulder stiffness. The 
purpose of this project is to see if subjects who receive a cortisone (Kenalog-triamcinolone) 
injection get more shoulder motion back than patients who receive an injection of lidocaine. 20 
people will be in the study with 10 receiving triamcinolone and 10 receiving lidocaine injections.  
 
STUDY PROCEDURES 
If you agree to be in this study you will be randomized (like the flip of a coin) to 
the control group or case group. Each group will receive 1 ultrasound guided 
injection. This is an intraarticular injection which means an injection into your 
shoulder joint. If you are in the control group you will be injected with 5 cc 
(about 1 teaspoon) of the drug lidocaine, 1%.you are in the case group you 
will be injected with 5 cc (about 1 teaspoon) that includes 4 cc of the drug 
triamcinolone, 40mg/cc (a steroid) together with 1 cc of the drug lidocaine, 
1%.”Study staff will not know which injection you receive. A radiologist will perform the 
injection which will take up to one hour. You will only have 1 injection as part of your 
participation in this study. You will also have a physical examination to look at your shoulder 
range of motion and we will ask you some questions. The physical exam and questions are part 
of your standard of care but information from the exam and questions will also be used for this 
research.   The physical exam will take about 10 minutes and answering  questions will take 
about 5 minutes.   
The questions will be about your ability to perform certain activities and your pain. The most 
personal or sensitive question you will be asked is do you take pain killers. 
You may refuse to answer any question.   


Completing the physical exam and questions will be done 4 times over 6-months. The first time 
is when you sign this consent form and before you receive the injection. You will complete the 
physical exam and questions again 6, 12, and 26 weeks after you receive the injection. 
We will review your medical records for clinical information related to your shoulder fracture 
during the course of your care. 
 
RISKS, STRESS, OR DISCOMFORT 
You may feel that there is a psycho-social risk, stress, discomfort, or potential for a breach of 
confidentiality, or the invasion of privacy that might result from completing  questionnaires or 
having your medical record reviewed for information related to care of your injury.  
There is a small risk of infection in the joint from either triamcinolone or lidocaine 
injection. There is also a small risk of allergic reaction from either the triamcinolone or the 
lidocaine injection. You may feel faint from the injection or feel pain at the site of injection. 
For the triamcinolone injection, there is a small risk of nerve damage, short term pain, and 
inflammation in the joint, tendon damage, loss of bone density (osteoporosis), death of 
nearby bone (osteonecrosis), an increase in blood pressure or a decrease in blood pressure, 
and a temporary increase in blood sugar. For the lidocaine injection, there is a small risk of 
drowsiness, agitation, lightheadedness, and a slight chance of significant cartilage damage 
(chondrolysis). There is a risk of bleeding from either injection. 
”Any side effects will be handled by the person providing you the injection, your orthopedic 
surgeon or the emergency room as necessary You should contact the people listed on the top 
of this consent form in the event of study-related injury, illness, or distress.  
 
ALTERNATIVES TO TAKING PART IN THIS STUDY 
If you choose not to be part of this study you will be given our standard physical therapy 
prescription.  
 
BENEFITS OF THE STUDY 
It is possible that by participating in this study your stiff shoulder will have an increased range 
of motion. 
 
SOURCE OF FUNDING 


T h e st u d y t e a m a n d/ or t h e U ni v ers it y of W as hi n gt o n is r ec ei vi n g fi n a nci al s u p p ort, fr o m NI A M S 
( Nati o nal I nstit ute of Art hritis a n d M usc ul os keletal a n d S ki n Diseases), a Di visi o n of t he 
Nati o nal I nstit ute of Healt h ( NI H).  
 
 
C O N FI D E N TI ALI T Y O F R E S E A R C H I N F O R M A TI O N  
Y o ur d at a will b e k e pt c o nfi d e nti al (li n k e d t o i d e ntifi ers) All of t h e i nf or m ati o n y o u pr o vi d e will  
b e c o nfi d e nti al.  H o w e v er, if w e l e ar n t h at y o u i nt e n d t o h ar m y o urs elf or ot h ers, w e m ust 
r e p ort t h at t o t h e a ut h oriti es.  
G o v er n m e nt or u ni v ersity st aff s o m eti m es r e vi e w st u di es s uc h as t his o n e t o m a k e s ur e t h e y 
ar e b ei n g d o n e s af el y a n d l e g all y.  If a r e vi e w of t his st u d y t a k es pl ac e, y o ur r ec or ds m a y b e 
ex a mi n e d.  T h e r e vi e w ers will pr ot ect y o ur pri v acy.  T h e st u d y r ec or ds will n ot b e us e d t o p ut 
y o u at l e g al ris k of h ar m.  
We ha v e a Certificate of C o nfi de ntialit y fr o m t he fe deral Nati o nal I nstit utes of Healt h. T his  
hel ps us pr otect y o ur pri v ac y. T he Certificate mea ns t hat we d o n ot ha ve t o gi ve o ut 
i de ntif yi n g i nf or mati o n a b o ut y o u e ve n if we are as ke d t o b y a c o urt of la w. We will use t he 
Certificate t o resist a n y d e ma n ds f or i de ntif yi n g i nf or mati o n.  We ca n’t use t he Certificate t o 
wit h h ol d y o ur researc h i nf or mati o n if y o u gi ve y o ur writte n  c o nse nt t o gi ve it t o a n i ns urer, 
e m plo yer, or ot her p ers o n. Als o, y o u or a me m ber of y o ur  fa mil y ca n s hare i nf or mati o n a b o ut 
y o urself or y o ur p art i n t his resear c h if y o u wis h.  T here are s o me li mits t o t his pr otecti o n. We 
will v ol u ntaril y pr o vi de t he i nf or mati o n t o:   A me m ber of t he fe deral g o v er n me nt w h o nee ds it 
i n or der t o a u dit or e v al uate t he researc h;  I n di vi d uals at t he U ni versit y of Was hi n gt o n, t he 
f u n di n g a ge nc y, a n d ot her gr o u ps i n v ol ve d i n t he researc h, if t he y nee d t he i nf or mati o n t o ma ke 
s ure t he res ear c h is bei n g d o ne c orr ectl y;   T he fe deral F o o d a n d Dr u g A d mi nistrati o n ( F D A), if 
re q uire d b y t he F D A 
A d escri pti o n of t his cli nic al tri al will b e a v ail a bl e o n htt p:// w w w.cli nic altri als. g o v , as r e q uir e d 
b y U. S. L a w.  T his W e b sit e will n ot i ncl u d e i nf or m ati o n t h at c a n i d e ntif y y o u. At m ost, t h e W e b 
sit e will i ncl u d e a s u m m ar y of t h e r es ults. Y o u c a n s e arc h t his W e b sit e at a n y ti m e.  
Y o ur p artici p ati o n i n t his st u d y will b e n ot e d i n y o ur U W m e dic al r ec or d . 
 
U S E O F I N F O R M A TI O N  
T h e  i nf or m ati o n c oll ect e d as p art of t his r es e arc h will n ot b e us e d or distri b ut e d f or f ut ur e 
r es e arc h st u di es. 
 
O T H E R I N F O R M A TI O N  
Y o u m a y r ef us e t o p artici p at e a n d y o u ar e fr e e t o wit h dr a w fr o m t his st u dy at a n y ti m e wit h o ut 
p e n alt y or l oss of b e n efits  t o w hic h y o u ar e ot h er wis e e ntitl e d. 


 
RESEARCH-RELATED INJURY 
If you think you have a medical problem or illness related to this research, contact Jonah Hebert 
Davies at 206.744.3000 right away. He will treat you or refer you for treatment.  
 
“It is important that you promptly tell the researchers if you believe that you have been injured 
because of taking part in this study. You can tell the researcher in person or call him/her at the 
number(s) listed at the top of this form. This number is monitored 24 hours a day.”  “If you are 
injured as a result of being in this study, necessary medical treatment will be offered at a UW 
Medicine facility.”  
 
 “The costs of the treatment may be billed to you or your health insurance  just like other 
medical costs, or it may be covered by the UW’s discretionary Human Subjects Assistance 
Program (HSAP), depending on a number of factors.  The researcher may request HSAP 
coverage by following established procedures. If you wish to request HSAP coverage yourself, 
contact the researcher or the UW Human Subjects Division at hsdinfo@uw.edu or 206-543-
0098. You may also call collect to the UW Human Subjects Division at 206-221-5940 if you do 
not otherwise have access to a telephone. Ask the researcher if you would like information 
about the limits and conditions of the HSAP. The UW does not normally provide any other form 
of compensation for injury. However, the law may allow you to seek payment for injury-related 
expenses if they are caused by malpractice or the fault of the researchers. You do not waive any 
right to seek payment by signing this consent form. We will bill your health insurance for 
treating problems that result from your proximal humerus fracture or from standard clinical 
care. If you have no health insurance or your insurance refuses to pay, we will bill you.” 
 
 
 
Printed name of study staff obtaining consent* 
Signature* 
Date* 
Subject’s statement 
This study has been explained to me.  I volunteer to take part in this research.  I have had a 
chance to ask questions.  If I have questions later about the research, or if I have been harmed 
by participating in this study, I can contact one of the researchers listed on the first page of this 
consent form.  If I have questions about my rights as a research subject, I can call the Human 
Subjects Division at (206) 543-0098 or call collect at (206) 221-5940.  I give permission to the 
researchers to use my medical records as described in this consent form.  I will receive a copy of 
this consent form. 


 
Printed name of subject 
 
Signature of subject  
 
 
Date 
 
 
 
 
Copies to: 
Subject 
 
 
 
 
 

Prot_002.pdf: