Clinical trial NCT04115644
Conditions: Full Thickness Rotator Cuff Tear Rotator Cuff Tendinitis
Sponsor: Michael Khazzam
Start date: 2017-05-01; Completion date: 2017-09-14
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid.

Specific Aim 1:

Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies.

The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.

Detailed description:
The proposed study is a three arm, double-blinded, prospective randomized controlled clinical trial with follow-up immediately after the injection and at day 2, and weeks 1, 2, 4, 6, and 12. In this study investigators will compare the effectiveness of ketorolac compared to corticosteroid.

Subjects being seen for a rotator cuff injury will be randomized into one of three treatment groups pertaining to their pathology. The intervention will begin once the subject has consented and answered the Baseline Outcome Shoulder Questionnaire. The Baseline Outcome Questionnaire consists of the Visual Analog Score, American Shoulder and Elbow Score, Single Assessment Numeric Evaluation, Pittsburgh Sleep Quality Index, Short Form-12, and questions pertaining to patient characteristics, injury characteristics, co-morbidities, patient history, medications, and demographics.

Arms: arm 1: will receive an injection of 5 cc 0.25% Marcaine without epinephrine arm 2: will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml arm 3: Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care
Interventions: intervention 1: Ketorolac intervention 2: Marcaine (placebo) intervention 3: Kenalog
Intervention descriptions: intervention 1: Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml intervention 2: Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine intervention 3: Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.

Protocol documents:
Prot_SAP_000.pdf: 
Official title: Effectiveness of Corticosteroid vs. Ketorolac Shoulder 
Injections: A Prospective Double-Blinded Randomized Trial 
 
NCT number: NCT04115644 
IRB Approved date: September 01, 2016 


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v5 6.21.16 
 
  Study 092014-097 
 
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E><:=*3879O5

>>H-../01./"
	+$$$&</"(=$
$!+$<=D</&
"=+:$$/"($+$&,
$&	$$
&:$$$++
$,$&(+&+:
&
:<&D&57="$
&,$,%":/+
5BGBIA5BC

H<-=<&=
-:$$$
$$+:$
$$$
@:&:%"+!+5B67IA78C

	#&,$&$$A75C
 
>3 (1+*!$)

1+
• 
 &!1+*
o 1"
o "+
• 
&!1+*
o "/<"/=
o  +N&(D
o %,57



v5 6.21.16 
 
  Study 092014-097 
 
%!*1"<1"=
&$
$
<'1"=<1'"=&58A77C+
#$HIH+I;
&+))$
$A7>C

"+<"=*
56A73C$,
++>$,$*+&
$&$&$
+&A79C

"/<"/=*H?
$,$A7KC($8,588$$$
8,588O588O$$<$)&=8O$I

 +N&(D< N(=*
$@&$$73
@$$HIHI&$+
A76C

%,57*
&&

0 -
• 
 ?0D
• 
()M$38$	++03<P3D3
JP5K=

>9
*"D&388+)+D&KK+)
$<788#D&538+):)=$+$
<$$$$=$$+)
+"+&!!&4':
*4':! 4':& &&
!$$"!

>6 &*(&D&9&
 
>G+)&&$&&
+)&&$+$+)
/$+$($
&+&+&+)
&($+)$&+$
$0&+:+&&$$&

&&+)&&+)?$&
$$*
• 
+)$&
• 
(+)?+
• 
+)$,&
• 
+)&$&+&
• 
!$&


2' 		



v5 6.21.16 
 
  Study 092014-097 
 
35+)+$$+&0$
&$&%
+)$,++&$$+)
+&
+

+$$$+)?

• 

• 

• 
 
• 
()&
• 
,+
• 
 '&

+)$$&+:$&
&$+$

	
!$&+$$&:$&
&+$&&
$&&"&+)+$+
:$$$$)+$
$&D
$+

+$+:$
:$$,$)&+


+)+$&+
$>+:
@+$$,@
$$57:&+$$
+&<&&=+&$
$$$&($
&&$+&$$.$$
$++0D$
$,

!&+)&
&,+$+
&$$++!
N



+)  + 
   $  ) * E 5     )
<=E7/"()<	=E>
)<	=

%58$)+)+:)&+&

1"<1"="/<"/=



v5 6.21.16 
 
  Study 092014-097 
 
 ++&$,@7&$)
573:+)+$K57:$)
$@+)&
57:$)

				
"$&+$
!
+)+
+!N
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+)+:@O$&1"+
+"+$+$

		*
   $    +     $  D + 
:+
  + )  +  %  +)   + )  +
<$$=78&+$
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$+)$
 $      +  $* E 5 <=* 9  879O  
#E7<:=*>879O7	>80#
E><:=*3879O5:

.)
&+:$&)$9

	 	
+)++&+1"&7:573$)
&+$,K57:$)
+:!N1""%,57 N(
+)$+"
&+:,+&+++&&


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& $  %, !  N 0   + :   
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v5 6.21.16 
 
  Study 092014-097 
 
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:D&>839

33"$+)+:@-
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3K  &     $     $  &   + 
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$$$%+$&
   &   +    +   
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v5 6.21.16 
 
  Study 092014-097 
 
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 :&+$,
&$?
+
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 :/"(
,:+& 
:$+/$/"(
&$)%+)$,++
&$$+)+&
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&$&&++)$"+&
!!&4':*4':!4':
& &&!$$
"!&(+)$&
$$&D&+
&++)

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"!&$"+&
!!&4':*4':!4':
& &&!$$
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++&&
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+&:+$$+D$$&
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v5 6.21.16 
 
  Study 092014-097 
 
B>$:
 
B3($$&0&&+&$ 
("T/%?+?$
 $&  $  &   <$ =    +   
&+$$&&

($* +&@+
$$4':

B9;$($*/0"

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&+,$+$$&
$&:&$
$$'+&)$
+$+$:$&$$
*
• 
:$+++#
• 
+:+&&#
• 
+::$$#
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#
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#
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$$:&,)<&
$:&=#
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• 
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
<=
• 
+$

+
+:$&$
#$$&+#$

0
:	'++
$:&
/"(::
A7G,>8C$$$+$,A7GC
&:$
+$)&A>5,>>C($
$3G$:&$$738$$$A>3>9C
+&&++A>K>6C'$
&&$!Q$$,+A>GC
+&&A>3C


58>+&$:+
+&$$
@(&&:++&&


v5 6.21.16 
 
  Study 092014-097 
 
$&$$ &+&$&
:&&&
&+,$+$$?&
$&:&$
$$




&& 4,	!
-$&$$
$&39%. 3K+"#H.I+&56
"75%.>57%"$.
@$$H+I:
(.-$$"&'

555 ;$&-<-=+
?$&$$$!&-
&D&78+)9O
D<:=D$D+
&:$&:$@$)
 
557E&-+$++'$
+)$)&++)
-(&$&+
&+D+H($+
$$*A>BC
U
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U
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.$+&$$
U
 +$+&$$
U
F$+

# 	 	
"&$++)+<+
&D+&$=&&+)?
&+)?

$		
"&D$$*
<5=D$&$@&+
$$+$&
<7=+&0&#+&
++&D&++&&

<>=&&+):$<
&&=&:


 +&+
$%$&
++$+
+)


v5 6.21.16 
 
  Study 092014-097 
 

	# 	 	
"HI$$
&$$*$,

$D
$&+
$+&$$&0+$(
&+$,@
&+
+)&&)
+)&
@$$D$
+@&
+&
$
&+
• 

• 
F$,
• 
'
<=
• 
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"&0-$
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.@(  (
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%		&!	'	#		
"+&$,
&+&
$$&+&$
&

%!	'	# 	 	
""+($$
D"0"+)$&

(
	# 	 	
"&


&$$&D+
+&+&$&+
&$

""$&+$+
$&$%";&
$%">988

&)			'			'		#'	# 	 	
&D"+$$$+
+(.--%"

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v5 6.21.16 
 
  Study 092014-097 
 
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v5 6.21.16 
 
  Study 092014-097 
 

537
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57&9BD+)9B+)++
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++&<=8G$&$$$&$$
$$&(++&$
&889$59OKK+)$$>$
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.
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"&+
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
 +: 
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& & D  + $  '(  "    +
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   $  * 5=  < )= 7=
/"()<:)=>=)<:)=
   + $ +)  +       $  &  

5*5*5&+:$$+&
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+&+$


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+?
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+++<&=&$
)      & $   E   $  &
:$$$D&788
+)&+$$,
 

	
"
 
 
1. 
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