A Double-blinded, Prospective, Randomized, Controlled Trial Comparing Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders
Phase: PHASE3
Conditions: DeQuervains Tenosynovitis, Lateral Epicondylitis, Tennis Elbow, Trigger Finger, Tenosynovitis, Inflammatory Disease
Sponsor: NYU Langone Health

  
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authorized in writing by the study regulatory sponsor 
 
 
 
 
 
 
 
 
A double-blinded, prospective, randomized, controlled trial 
comparing dexamethasone versus ketorolac injection for the 
treatment of local inflammatory hand and upper extremity 
disorders: a pilot study 
 
 
 
 
Regulatory Sponsor: 
Anthony Sapienza, MD  
Department of Orthopaedic Surgery 
530 First Avenue, Suite 8U 
New York, NY 10003 
Funding Sponsor: 
Department of Orthopaedic Surgery 
530 First Avenue FIRST AVENUE, Suite 8U 
New York, NY 10003 
Study Product: 
Ketorolac  
Protocol Number: 
S12-00878 
IND Number: 
IND 120923 
NCT Number: 
NCT02266433 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Initial version: 7/22/2012 
Amended: 07/31/2018 
 
Clinical Research Protocol 

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Table of Contents 
 
STUDY SUMMARY ....................................................................................................................................... 1 
1 
INTRODUCTION ..................................................................................................................................... 2 
1.1 
BACKGROUND .................................................................................................................................... 2 
1.2 
STUDY DRUGS ................................................................................................................................... 2 
1.3 
PRECLINICAL DATA ............................................................................................................................. 2 
1.4 
CLINICAL DATA TO DATE ..................................................................................................................... 3 
1.5 
DOSE RATIONALE ............................................................................................................................... 3 
1.6 
RESEARCH RISKS & BENEFITS ............................................................................................................ 4 
1.6.1 
Risk of Study Drug .................................................................................................................... 4 
1.6.2 
Potential benefits ...................................................................................................................... 4 
2 
STUDY OBJECTIVES ............................................................................................................................. 5 
3 
STUDY DESIGN ...................................................................................................................................... 5 
3.1 
GENERAL DESIGN............................................................................................................................... 5 
3.2 
PRIMARY STUDY ENDPOINTS .............................................................................................................. 5 
3.3 
SECONDARY STUDY ENDPOINTS ......................................................................................................... 5 
3.4 
PRIMARY SAFETY ENDPOINTS ............................................................................................................. 5 
4 
SUBJECT SELECTION AND WITHDRAWAL ....................................................................................... 6 
4.1 
INCLUSION CRITERIA ........................................................................................................................... 6 
4.2 
EXCLUSION CRITERIA ......................................................................................................................... 6 
4.3 
SUBJECT RECRUITMENT AND SCREENING ............................................................................................ 6 
4.4 
SUBJECT WITHDRAWAL ...................................................................................................................... 7 
5 
STUDY DRUGS ...................................................................................................................................... 7 
5.1 
KETOROLAC (INVESTIGATIONAL AGENT) .............................................................................................. 7 
5.1.1 
Description ................................................................................................................................ 7 
5.1.2 
Treatment regimen ................................................................................................................... 7 
5.2 
DEXAMETHASONE (STANDARD OF CARE COMPARATOR)........................................................................ 8 
5.2.1 
Description ................................................................................................................................ 8 
5.2.2 
Treatment regimen ................................................................................................................... 8 
5.3 
LIDOCAINE (STANDARD OF CARE CO-ADMINISTERED ANESTHETIC) ........................................................ 8 
5.4 
SUPPLY OF STUDY DRUGS ................................................................................................................... 8 
5.5 
METHOD FOR ASSIGNING SUBJECTS TO TREATMENT GROUPS.............................................................. 8 
5.6 
PREPARATION AND ADMINISTRATION OF STUDY DRUG ......................................................................... 8 
5.7 
PRIOR AND CONCOMITANT THERAPY ................................................................................................... 9 
5.8 
BLINDING OF STUDY DRUG ................................................................................................................. 9 
6 
STUDY PROCEDURES .......................................................................................................................... 9 
7 
STATISTICAL PLAN .............................................................................................................................. 9 
7.1 
SAMPLE SIZE DETERMINATION ............................................................................................................ 9 
7.2 
STATISTICAL METHODS ....................................................................................................................... 9 
8 
SAFETY AND ADVERSE EVENTS ...................................................................................................... 10 
8.1 
DEFINITIONS ..................................................................................................................................... 10 
8.2 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ..................................... 10 
8.2.1 
Notifying the IRB ..................................................................................................................... 10 
8.3 
UNBLINDING PROCEDURES ............................................................................................................... 11 
8.4 
MEDICAL MONITORING ...................................................................................................................... 12 
9 
DATA HANDLING AND RECORD KEEPING ...................................................................................... 12 

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9.1 
CONFIDENTIALITY AND HIPAA .......................................................................................................... 12 
9.2 
SOURCE DOCUMENTS....................................................................................................................... 12 
9.3 
STUDY RECORDS ............................................................................................................................. 12 
9.4 
STUDY ELECTRONIC DATA ................................................................................................................ 12 
9.5 
RECORDS RETENTION ...................................................................................................................... 13 
10 
STUDY MONITORING, AUDITING, AND INSPECTING ................................................................... 13 
10.1 
STUDY MONITORING  ...................................................................................................................... 13 
10.2 
AUDITING AND INSPECTING ............................................................................................................. 14 
11 
ETHICAL CONSIDERATIONS ........................................................................................................... 14 
12 
STUDY FINANCES ............................................................................................................................. 14 
12.1 
FUNDING SOURCE .......................................................................................................................... 14 
12.2 
CONFLICT OF INTEREST .................................................................................................................. 14 
12.3 
SUBJECT STIPENDS OR PAYMENTS ................................................................................................. 14 
13 
PUBLICATION PLAN ......................................................................................................................... 14 
14 
REFERENCES .................................................................................................................................... 14 
 
 
 

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List of Abbreviations 
 
 
AE 
Adverse Event 
AIDS 
Acquired immunodeficiency disease syndrome 
CNS 
Central nervous system 
FDA 
Food and Drug Administration 
HIPAA Health Information Portability and Accountability Act 
HIV 
Human immunodeficiency virus 
HJD 
Hospital for Joint Diseases 
NSAID Non-steroidal anti-inflammatory drug 
NYU 
New York University 
PHI 
Protected Health Information 
 
 

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Study Summary 
Title 
A double-blinded, prospective, randomized, controlled trial comparing 
dexamethasone versus ketorolac injection for the treatment of local 
inflammatory hand and upper extremity disorders: a pilot study 
Short Title 
Ketorolac in hand and upper extremity soft tissue disorders 
Protocol Number 
Pending 
Phase 
Phase 3 
Methodology 
Randomize, double-blind, prospective active control trial 
Study Duration 
2 – 3 years 
Study Center(s) 
Single-center – NYU Langone Medical Center 
Objectives 
The primary objective of this study is to compare local corticosteroid hand 
and elbow injections to placebo or ketorolac to determine if there is an equal 
or better reduction of symptoms for common orthopaedic upper extremity 
disorders including: De Quervain’s tenosynovitis, trigger fingers, and tennis 
elbow (lateral epicondylitis). 
Number of Subjects 
Goal of 780 total subjects: 
• 260 subjects in each of the 3 treatment groups (De Quervain’s 
tenosynovitis, trigger fingers and lateral epicondylitis) 
Diagnosis and Main 
Inclusion Criteria 
Subjects 18 years or older, with any of the following diagnoses: De 
Quervain’s tenosynovitis, trigger fingers, or lateral epicondylitis 
Study Product, Dose, 
Route, Regimen 
Peritendonous soft tissue injection for De Quervain’s tenosynovitis, trigger 
fingers and lateral epicondylitis: 
• 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine  
Duration of 
administration 
Single administration, with a second injection permitted only once as subject 
desires due to no major clinical response at the 4 or 8-week follow-up. 
Reference therapy 
Standard of care peritendonous soft tissue injection for De Quervain’s 
tenosynovitis, trigger fingers, and lateral epicondylitis: 
• 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) 
of 1% lidocaine 
Statistical 
Methodology 
The sample size as stated above was derived by a power analysis. A power 
analysis indicated that a total sample size of 200 patients randomized equally 
(1:1 randomization) to each treatment arm (i.e trigger finger, De Quervain's 
disease, and tennis elbow) without any blocking or stratification would provide 
80% statistical power (alpha=.05, beta=0.20) to detect a 10% difference in 
mean DASH scores between cohorts assuming a common standard deviation 
of 25% (effect size = 10/25 = 0.4). To account for an estimated 30% loss to 
follow-up, we plan to enroll a total of 260 patients per treatment arm (i.e. trigger 
finger, De Quervain's disease, and tennis elbow). In total, there will be 
approximately 780 patients enrolled among all treatment arms. 
 

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1 Introduction 
This document is a protocol for a human research study. This study is to be conducted in accordance with 
US government research regulations, and applicable international standards of Good Clinical Practice, 
and institutional research policies and procedures. 
1.1 Background 
Many orthopaedic hand disorders are comprised of different forms of tendonitis, tenosynovitis, and arthritis. 
The inflammatory processes of these disorders cause discomfort and functional impairment for patients. 
Decreasing the inflammatory response by use of splinting, physiotherapy, systemic anti-inflammatory 
agents, and local anti-inflammatory injections helps to alleviate some or all of the discomfort (2-4).  Steroid 
injections are not entirely benign, and complications include tendon ruptures, subcutaneous fat atrophy, 
skin pigmentation changes, cartilage damage, and hyperglycemic responses in diabetics (9-11, 22-23). 
Studies have shown that ketorolac, a non-steroidal anti-inflammatory agent has a potent anti-inflammatory 
effect comparable to corticosteroids and a strong analgesic effect allowing for reduced opioid consumption 
postoperatively (7, 8). One could argue that the potent anti-inflammatory properties of ketorolac could be 
used to substitute for local corticosteroid injections in treating certain hand disorders.  Given the side-effect 
profile for corticosteroids it may be beneficial to treat inflammatory disorders with local ketorolac injections. 
Nonsteroidal anti-inflammatory agents also have their known systemic adverse effects including gastric 
ulceration and intestinal bleeding as well as impairment of renal function. Most of these side effects are 
theoretically avoided with local tissue injections. 
1.2 Study Drugs 
Ketorolac 
The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the 
investigational agent in this study 
 
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID).  The approved indication for Ketorolac is for 
the short-term (≤5 days) management of moderately severe, acute pain that requires analgesia at the opioid 
level, usually in a postoperative setting.  It is highly protein bound (99%) and is largely metabolized by the 
liver.  In it’s approved indication it is contraindicated for those with renal impairment, active peptic ulcer 
disease, pregnant or nursing females, individuals with NSAID hypersensitivity, or individuals at high risk for 
bleeding/clotting disorders. 
 
Dexamethasone 
Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within 
its labeled indication for this study:  intra-articular or soft tissue injection for: synovitis of osteoarthritis, 
epicondylitis, acute nonspecific tenosynovitis.  It is the active comparator in this study. 
 
In its approved indication there use limitations for immunocompromised individuals, pregnant females, 
persons with allergy to steroids, individuals with systemic fungal infections, and individuals with cerebral 
malaria.  It is contra-indicated in systemic fungal infections, and hypersensitivity to any component of this 
product, including sulfites. 
 
Lidocaine 
Lidocaine is a local anesthetic of the amide type, and will be used within its labeled indication for this study: 
production of local or regional anesthesia by infiltration techniques such as percutaneous injection.  It is to 
be given as concomitant therapy with both the investigational agent, ketorolac injection, and the standard 
of care therapy, dexamethasone injection. 
1.3 Preclinical Data 
There are no published studies in the literature that examine local injections of ketorolac in treating 
orthopaedic hand pathology.  Shapiro et al investigated the effects of local injection of corticosteroid and 
ketorolac on histologic and biomechanical properties of rabbit tendon and cartilage (1). Their goal was to 
determine the safety and efficacy of local injection of NSAIDs in humans by first testing the histologic and 

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biomechanical properties of tissues injected with NSAIDs versus corticosteroids in rabbit models. Among 
the results obtained the study showed that methylprednisolone compared to ketorolac demonstrated a 
significant increase in cartilage necrosis which was not seen at all in the ketorolac group. The damaging 
effects of corticosteroids on cartilage has been studied in the literature and it is well known that it is 
detrimental to cartilage if overused (13, 14). The Shapiro study also showed no notable difference in 
histologic inflammatory cells when comparing the two groups and no evidence of tendon necrosis despite 
other studies showing evidence for tendon necrosis/rupture with corticosteroid injections. Case reports exist 
in the literature that report flexor digitorium superficialis and profundus ruptures following corticosteroid 
injections for trigger fingers (9, 26). In addition, rabbit model studies show that corticosteroid injection into 
tendons produce necrosis of collagen resulting in incomplete repair and increased risk for rupture of the 
tendon (12).  The Shapiro study concluded that peri-tendinous injections of either corticosteroid or ketorolac 
may not be harmful, however cartilage seems to show damage with corticosteroid injections alone (1). The 
Shapiro study shows that ketorolac does not cause any more harm than corticosteroids when analyzing 
biomechanical and histologic properties in rabbit models and in some cases causes less damage as 
demonstrated with cartilage. 
1.4 Clinical Data to Date 
Investigations comparing local injections of corticosteroids and non-steroidal anti-inflammatory drugs 
(NSAIDs) have been conducted. One study by Karthikeyan et al showed that subacromial injections with 
corticosteroids outperformed injections with tenoxicam at 2 and 4 weeks post injection (24). More recently, 
a double-blind randomized study between triamcinolone and ketorolac injections into the subacromial 
space demonstrated that ketorolac showed greater improvements in shoulder functional scores at 4-weeks 
of follow-up and therefore was found to have equivalent if not superior efficacy compared to steroids without 
the potential steroid side-effects such as tissue atrophy or cartilage damage (25). 
 
In addition there are several studies that examine the potent anti-inflammatory effects of ketorolac when 
compared to corticosteroids in other fields of research. The ophthalmology literature has examined the 
effect of ketorolac for postoperative inflammatory control following cataract surgery. When comparing it to 
corticosteroids, ketorolac topical ophthalmic formulations were as effective as corticosteroids in controlling 
inflammation and pain following cataract surgery without the known complications associated with 
corticosteroids including infection, increased intra-ocular pressure, and inhibition of cellular wound-healing 
(6, 8). 
1.5 Dose Rationale 
Dose rationale for the study was determined based on available concentrations and clinical data. 
Ketorolac is readily available at very low costs in vials of 15mg/mL and 30mg/mL. The Shapiro study that 
examined ketorolac injection into rabbit tendon and cartilage showed favorable safe results using 
15mg/mL concentrations and the Min study comparing ketorolac to triamcinolone in the shoulder used 
60mg of ketorolac (1,25). We chose 30mg/mL concentrations simply because for small injections in the 
hand and upper extremity this should prove sufficient if any outcome were to be recorded. A lower 
concentration puts the study at risk for showing no clinical response. Because the side-effect profile is 
essentially equivalent between the two we chose to proceed using the higher of the two readily available 
concentrations. 
 
The dose of dexamethasone used in this study is based on the standard of care used on patients for hand 
and upper extremity pathology which consists 4mg/mL of dexamethasone sodium phosphate per injection.  
 
Lastly, 1% lidocaine is used in this study to provide simple analgesia from the injections for immediate relief 
for patients as these injections can be painful at times. This is a standard of care dose of local analgesia.  
  
 

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1.6 Research Risks & Benefits 
1.6.1 Risk of Study Drug 
All patients will be monitored closely as per the data and safety monitoring plan established for this project 
for any side-effects that may arise from using these medications for local soft tissue infections. Patients will 
be checked for common side effects at the time of their follow-up visits. In addition, the patient will be given 
instructions to contact the private office/HJD hand clinic to report any potential side effects that they may 
be experiencing.  
 
Risks associated with dexamethasone injections include (9-11, 22-23): 
- 
Pain/discomfort at the site of injection 
- 
Tendon ruptures 
- 
Subcutaneous fat atrophy 
- 
Skin pigmentation changes 
- 
Cartilage damage 
- 
Hyperglycemic responses in diabetic patients 
 
Risks associated with Ketorolac in the literature refer mainly to systemic or intramuscular administration 
and no risks are noted for local soft tissue injections. Ketorolac has been shown to cause (28-29): 
- 
Pain/discomfort at the site of injection 
- 
Increased risk for bleeding 
- 
Skin rashes 
- 
Pruritis 
- 
Allergic reactions such as face/throat swelling 
- 
Abdominal pain/GI upset 
- 
Gastrointestinal ulcers/GI bleeding 
- 
Renal impairment 
 
Risks associated with lidocaine mainly involve side-effects from systemic administration which include 
(30,31): 
- 
CNS depression or excitation (light-headedness, nervousness, apprehension, euphoria, 
confusion, dizziness, drowsiness, tinnitus, blurred vision, vomiting, twitching, convulsions, 
unconsciousness, respiratory depression and arrest) 
- 
Bradycardia 
- 
Hypotension 
- 
Cardiovascular collapse 
- 
Allergic reactions 
 
Protection against risks 
Patients will be injected using sterile technique to avoid any infectious risk with the medication. Patient will 
be informed that some discomfort will be experienced with needle injection however small gauge needles 
will be used to minimize the pain felt by the patient. Any patient that experiences an adverse event will be 
withdrawn from the study and will follow-up with their primary care provider promptly.  
 
Payment for the office visit and any procedures performed will be billed to the insurance company of the 
patient and the patient is responsible for any copayments needed. 
1.6.2 Potential benefits 
This research study may change how patients are treated with simple hand/upper extremity inflammatory 
disorders. 

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2 Study Objectives 
The primary objective of this study is to compare local corticosteroid hand and elbow injections to ketorolac 
to determine if there is an equal or better reduction of symptoms for common orthopaedic upper extremity 
disorders including: De Quervain’s tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). 
3 Study Design 
3.1 General Design 
This study will be a double-blinded prospective randomized controlled trial comparing the effects of 
dexamethasone (standard of care) and ketorolac in hand and upper extremity soft tissue disorders.  
3.2 Primary Study Endpoints 
The primary endpoint will be functional outcome scores at various follow-up time points using the 
quickDASH and EQ-5D questionnaire as well as a pain visual analog scale.  The primary endpoint for the 
study would be resolution of symptoms or surgical intervention.   
 
Primary endpoints will depend on the diagnosis of the patient. The following details what will be assessed 
at each follow-up visit after the initial injection: 
1) Trigger finger group primary endpoint measures include the resolution of objective triggering and 
resolution of tenderness at the A1 pulley at subsequent follow-up visits. In addition, patients will 
be graded based on the Quinnell system to monitor for improvement: 0-normal movement of 
finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-
fixed deformity (15). Patients will complete the quickDASH and EQ-5D questionnaires as well as 
a pain visual analog scale at each follow-up visit (27).  
2) De Quervain’s tenosynovitis group primary endpoint measures will include objective physical 
exam findings for the resolution of pain/tenderness over the 1st dorsal extensor compartment and 
the resolution of pain elicited during the Finkelstein test. In addition, patients will complete the 
quickDASH and EQ-5D questionnaires as well as a pain visual analog scale at each follow-up 
visit. 
3) Lateral epicondylitis of the elbow group primary endpoint measures include the resolution of 
lateral elbow pain/tenderness over the extensor origin and the resolution of pain at the lateral 
epicondyle with resisted wrist extension during follow-up examinations. Patient grip strength will 
also be measured in this cohort using a hand dynamometer. Grip strength will be measured at 
each follow-up and the average of three tests with 20 second rests in between will be recorded. 
The contralateral side will also be measured for comparison.  Lastly, patients will complete the 
quickDASH and EQ-5D questionnaires as well as a pain visual analog scale at each follow-up 
visit.  
3.3 Secondary Study Endpoints 
Secondary outcome measures include objective physical exam findings (clinical grading/classification 
systems), and grip/pinch strength using dynamometers. 
3.4 Primary Safety Endpoints 
Patients will follow-up after the first injection at 4-weeks, 8-weeks, 12-weeks, and 6 months post injection. 
During follow-up appointments patients in this study will be monitored based on history and physical exam 
for any side-effects associated with the administration of local soft tissue injections of dexamethasone or 
ketorolac. 
Patients can withdraw from the study at any time if they wish. Patients whose symptoms do not improve 
and are candidates for surgery can withdraw from the study and have surgery to correct their specific 
pathology (secondary endpoint). Patients enrolled in the study will be counseled regarding the likelihood of 

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the injections working and will be given the opportunity for a second injection at 4 weeks from the time of 
the first injection if no significant symptoms have resolved. Ultimately it will be up to the patient whether 
they chose another injection or if they want to resort to a surgical intervention.  
 
Patients who receive ketorolac by randomization as the therapeutic option will have an expected failure 
rate of approximately 30-50% based on clinical experience and literature review that shows the failure rate 
of dexamethasone (standard of care) on trigger fingers. The study population will be statistically analyzed 
biannually to determine if there is a significant difference in the rate of failures between the two groups, 
however a sizeable study population needs to be established before these conclusions can be drawn. If the 
rate of failure proves to be statistically significant between the ketorolac and dexamethasone group then 
the study will have to be ethically abandoned. This determination needs to take into consideration the pre-
treatment symptoms of the patient since patients who begin treatment with a severe trigger finger (quinnell 
score=4) have a different prognosis compared to patients who begin with a mild trigger finger (quinnell 
score=1).  
4 Subject Selection and Withdrawal 
4.1 Inclusion Criteria 
• 
Patients must be diagnosed with at least one of the following: trigger finger, de quervain’s 
tenosynovitis, or tennis elbow (lateral epicondylitis) 
• 
Subjects may be treated for multiple sites of pathology simultaneously or sequentially and up to 
three sites of pathology can receive an injection during an office visit 
• 
Subjects may have a maximum total of two injections at each site of pathology during the study 
• 
Age 18 years of age or older from all racial/ethnic types 
• 
Both males and females 
• 
Study participants will not receive splinting as a therapeutic addition to their treatment. 
• 
Study participants will include any NYU employee or students as these individuals also can get 
hand and upper extremity pathology. It will be specifically reiterated to them that their academic 
status or grades, or employment will not be affected by their decision to participate in this study. 
Record of the participation cannot be linked to an academic record. 
4.2 Exclusion Criteria 
• 
Patients had previous steroid injection at the site in question within 90 days of enrollment 
• 
Patients with a history of gastric ulcers, renal impairment, allergy/hypersensitivity to non-steroidal 
anti-inflammatory (NSAID) or lidocaine derivative medications, immunocompromised patients 
(HIV/AIDs) and pregnant females 
4.3 Subject Recruitment and Screening 
This study comprises several arms each of which is a specific disease involving the hand and upper 
extremity: trigger finger, De Quervain’s disease, and tennis elbow. Subjects will be identified in the office 
visit for their hand and upper extremity complaints. 
 
Equal gender distributions are expected in this study. Subjects will be 18 years of age or older. The hand 
and upper extremity disorders involved in the study are rarely if ever seen in patient population younger 
than 18 years of age. There will be no restriction to racial/ethnic background in terms of enrollment nor will 
any one particular racial/ethnic background will be sought out for enrollment over another. The diversity of 
the research subjects will be dependent on the diversity of patients seen in the hand offices of the 
investigators which is very broad as is the New York City Metropolitan area. 
 
Patients will be enrolled from the private office of orthopaedic hand surgeons (Dr. Paksima and Dr. 
Sapienza) and the resident hand clinic at NYU Hospital for Joint Diseases held at the 23rd street clinic. 

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There are no vulnerable subjects included in this study.  
4.4 Subject Withdrawal 
Patients can withdraw from the study at any time if they wish. Patients whose symptoms do not improve 
and are candidates for surgery can withdraw from the study and have surgery to correct their specific 
pathology (secondary endpoint). Patients enrolled in the study will be counseled regarding the likelihood of 
the injections working and will be given the opportunity for a second injection at 4 weeks from the time of 
the first injection if no significant symptoms have resolved. Ultimately it will be up to the patient whether 
they chose another injection or if they want to resort to a surgical intervention.  
 
If patients experience adverse events they will be counseled regarding treatment alternatives for their 
pathology and any complications from the injection/medications will be treated appropriately. Because the 
study consists of a single injection at time point zero followed by serial examinations and completion of 
functional outcome surveys there is no need to stop treatment and withdraw patients from the study despite 
having an adverse event. The patient will simply not receive any more injections. 
5 Study Drugs  
5.1 Ketorolac (Investigational Agent) 
5.1.1 Description 
Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID).  The approved indication for Ketorolac is for 
the short-term (≤5 days) management of moderately severe, acute pain that requires analgesia at the opioid 
level, usually in a postoperative setting.  It is highly protein bound (99%) and is largely metabolized by the 
liver.  It is indicated for short-term management of severe acute pain as intravenous or intramuscular 
injections. 
 
In its approved indication it is contraindicated for those with renal impairment, active peptic ulcer disease, 
pregnant or nursing females, individuals with NSAID hypersensitivity, or individuals at high risk for 
bleeding/clotting disorders. 
5.1.2 Treatment regimen 
The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the 
investigational agent in this study.  Ketorolac will be administered as a peritendonous soft tissue injection 
of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. 
 
Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection 
to determine clinical response. A second injection can be given only once at each site of pathology if the 
patient desires due to no clinical response at the 4 or 8-week follow-up.   
 
Patients will be divided into two groups. Group 1: 1 mL of dexamethasone sodium phosphate (4mg/mL) 
and 0.5 mL (5mg) of 1% lidocaine (standard of care). Group 2: 1 mL of ketorolac (30mg/mL) and 0.5 mL 
(5mg) of 1% lidocaine (experimental group). Patients will be followed at the initial visit, 4-weeks, 8-weeks, 
12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only 
once if the patient desires at the 4 or 8-week follow-up. These injections will be offered if the patient reports 
some improvement since the prior injection but still some persistent symptoms that have not completely 
resolved or if they had no response but would like another attempt to avoid surgery by receiving a second 
injection. The injection administered for the second time will correspond to the randomized group for the 
patient. Patients will not be compared separately if they receive one or two injections. However, with enough 
enrollment subgroup analysis can be performed to determine if receiving two injections significantly alters 
the outcome of the patient in regards to functional score improvement, surgery endpoint, or resolution of 
symptoms. The primary endpoint for the study would be resolution of symptoms or surgical intervention.   
 

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Patients receiving a second injection should be allowed to continue in the study. It is common practice for 
patients as part of the standard of care to receive multiple injections for hand and upper extremity pathology 
until these injections have been deemed non-therapeutic by the treating physician and surgical intervention 
is indicated. 
5.2 Dexamethasone (Standard of care comparator) 
5.2.1 Description 
Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity.  It is indicated for intra-
articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis.  
 
In its approved indication there use limitations for immunocompromised individuals, pregnant females, 
persons with allergy to steroids, individuals with systemic fungal infections, and individuals with cerebral 
malaria.  It is contra-indicated in systemic fungal infections, and hypersensitivity to any component of this 
product, including sulfites. 
5.2.2 Treatment regimen 
Dexamethasone will be used within its labeled indication for this study:  intra-articular or soft tissue injection 
for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis.  It is the active comparator in 
this study. 
 
Dexamethasone will be administered as a peritendonous soft tissue injection of 1 mL of dexamethasone 
sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine 
 
Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection 
to determine clinical response. A second injection can be given only once if the patient desires due to no 
clinical response at the 4 or 8-week follow-up. 
5.3 Lidocaine (Standard of care co-administered anesthetic) 
Lidocaine is a local anesthetic of the amide type, and will be used within its labeled indication for this study: 
production of local or regional anesthesia by infiltration techniques such as percutaneous injection.  It will 
be administered as 0.5 mL (5mg) of 1% lidocaine in combination with both the investigational agent, 
ketorolac injection, and the standard of care therapy, dexamethasone injection.  
5.4 Supply of study drugs 
Medications will be provided by the NYUHJD pharmacy for the 23rd street clinic. For the faculty private 
offices, the medications will be provided by their own office and stored at those sites as well. The primary 
endpoint for the study would be resolution of symptoms or surgical intervention. They will be stored in their 
pre-packaged containers at room temperature which is within the storage temperature parameters for the 
medication of 20 to 25°C (68 to 77°F). 
5.5 Method for Assigning Subjects to Treatment Groups 
When a patient is enrolled and consented into the study a random envelope (labeled with an identification 
number) will be opened and in it will contain the group that the patient is randomized to: steroid or 
ketorolac. Envelopes are made using a randomization software that chooses one of the two drugs at 
random.  When a patient is being enrolled in the study for an additional site of pathology, they will receive 
the same drug to which they were initially randomized at each site of pathology and a separate identifier 
number will be used to track the progress of each site. 
5.6 Preparation and Administration of Study Drug 
On the date of the planned injection a nurse, resident, fellow or research assistant present at the site and 
not directly involved in the patient’s care will draw up the medication appropriate to the randomized 
treatment assignment and hand it to the physician who will administer the drug. Both the patient and the 
treating physician are blinded to the identity of the medication. Patient data will be recorded and kept in 

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the envelope and only the hand department research assistant or the resident in charge of this project 
(who will not be directly involved in patient care) will know the identity of the treatment given to the 
enrolled patients. Because both liquids are clear the contents of the syringes do not need to be covered. 
5.7 Prior and Concomitant Therapy 
There are no restrictions to concomitant oral medical therapy for subjects enrolled in this study 
5.8 Blinding of Study Drug 
The study will be a double-blinded prospective randomized controlled trial. Drugs will be stored in the local 
clinic/office medication storage room. When a patient is enrolled and consented into the study a random 
envelop (labeled with an identification number) will be opened and in it will contain the group that the patient 
is randomized to: steroid or ketorolac. On the date of the planned injection a nurse, resident, fellow or 
research assistant present at the site and not directly involved in the patient’s care will draw up the 
medication and hand it to the physician who will administer the drug. Both the patient and the treating 
physician are blinded to the identity of the medication. Patient data will be recorded and kept in the envelope 
and only the hand department research assistant or the resident in charge of this project (who will not be 
directly involved in patient care) will know the identity of the treatment given to the enrolled patients. 
Because both liquids are clear the contents of the syringes do not need to be covered  
6 Study Procedures 
A specific patient population with hand and upper extremity pathologies will be studied including trigger 
finger, De Quervain’s tenosynovitis, and lateral elbow epicondylitis. Patients with trigger finger will be 
diagnosed clinically by observing symptoms of catching or triggering of the digit with range of motion and 
tenderness localized to the A1 pulley. Patients with De Quervain’s tenosynovitis will be identified clinically 
as having pain/tenderness at the first dorsal extensor compartment combined with a positive Finkelstein 
test (pain during full thumb adduction with ulnar deviation of the wrist). Patients with tennis elbow (lateral 
epicondylitis) will be defined as having lateral elbow pain/tenderness over the extensor origin and/or pain 
at the lateral epicondyle with resisted wrist extension. 
 
Patients will be consented at the time of their visit with the hand surgeon. Based on inclusion/exclusion 
criteria it will be determined whether or not to enroll the patient in the study. Consent will be performed by 
discussing the study with the patient in the privacy of the exam room and having them sign the written 
consent form that will be IRB approved. There is no payment to the patient for participation and they will be 
charged for their normal office visit for treatment rendered. 
7 Statistical Plan 
7.1 Sample Size Determination 
The sample size as stated above was derived by a power analysis. A power analysis indicated that a total 
sample size of 200 patients randomized equally (1:1 randomization) to each treatment arm (i.e trigger 
finger, De Quervain's disease, and tennis elbow) without any blocking or stratification would provide 80% 
statistical power (alpha=.05, beta=0.20) to detect a 10% difference in mean DASH scores between cohorts 
assuming a common standard deviation of 25% (effect size = 10/25 = 0.4). To account for an estimated 
30% loss to follow-up, we plan to enroll a total of 260 patients per treatment arm (i.e. trigger finger, De 
Quervain's disease, and tennis elbow). In total, there will be approximately 780 patients enrolled among all 
treatment arms, however we expect the trigger finger group to be the treatment arm that most rapidly enrolls 
patients. 
7.2 Statistical Methods 
Statistics will be conducted by the statistician on faculty with the NYU Hospital for Joint Diseases. Primary 
analysis will consist of comparisons of the baseline functional scores (quickDASH and EQ5D). These 
scores will be analyzed and compared to subsequent scores at the various follow-ups (4-weeks, 8-weeks, 

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12-weeks, 6 months). In addition, changes in scores will also be analyzed between the baseline scores 
and the subsequent follow-ups. Statistical significance will be determined by p-values less than 0.05.  
 
Secondary analysis will consist of physical exam findings and resolution of symptoms following injections 
as well as grip or pinch strength using pressure dynamometers to gage improved function following 
injections as well. In addition, observation of side effects will also be included in the secondary analysis. 
8 Safety and Adverse Events 
8.1 Definitions 
Adverse Event 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 
• a congenital anomaly or birth defect 
• an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly of major 
clinical significance.   They may jeopardize the subject, and may require intervention to prevent one of the 
other serious outcomes noted above.  For example, drug overdose or abuse, a seizure that did not result 
in in-patient hospitalization, or intensive treatment of bronchospasm in an emergency department would 
typically be considered serious.  
 
Recording of Adverse Events 
At each contact with the subject, information will be sought from each subject on adverse events by 
specific questioning and, as appropriate, by examination.  Information on all adverse events should be 
recorded immediately in the source document, and also in the appropriate adverse event module of the 
case report form (CRF).  All clearly related signs, symptoms, and abnormal diagnostic procedures results 
should recorded in the source document, though should be grouped under one diagnosis. 
 
All adverse events occurring during the study period must be recorded.  The clinical course of each event 
should be followed until resolution, stabilization, or until it has been determined that the study treatment or 
participation is not the cause.  Serious adverse events that are still ongoing at the end of the study period 
must be followed up to determine the final outcome.  Any serious adverse event that occurs after the 
study period and is considered to be possibly related to the study treatment or study participation should 
be recorded and reported immediately. 
8.2 Reporting of Serious Adverse Events and Unanticipated Problems 
8.2.1 Notifying the IRB 
Federal regulations require timely reporting by investigators to their local IRB of unanticipated problems 
posing risks to subjects or others.  The following describes the NYULMC IRB reporting requirements, 

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though Investigators at participating sites are responsible for meeting the specific requirements of their 
IRB of record.  
 
Report Promptly, but no later than 5 working days: 
Researchers are required to submit reports of the following problems promptly but no later than 5 working 
days from the time the investigator becomes aware of the event: 
• 
Unanticipated problems including adverse events that are unexpected and related 
– Unexpected: An event is “unexpected” when its specificity and severity are not accurately 
reflected in the protocol-related documents, such as the IRB-approved research protocol, any 
applicable investigator brochure, and the current IRB-approved informed consent document 
and other relevant sources of information, such as product labeling and package inserts.  
– Related to the research procedures: An event is related to the research procedures if in the 
opinion of the principal investigator or sponsor, the event was more likely than not to be 
caused by the research procedures.  
– Harmful: either caused harm to subjects or others, or placed them at increased risk 
 
Other Reportable events: 
The following events also require prompt reporting to the IRB, though no later than 5 working days: 
• Complaint of a research subject when the complaint indicates unexpected risks or the complaint 
cannot be resolved by the research team. 
• Protocol deviations or violations (includes intentional and accidental/unintentional deviations 
from the IRB approved protocol) for any of the following situations:  
– one or more participants were placed at increased risk of harm  
– the event has the potential to occur again 
– the deviation was necessary to protect a subject from immediate harm 
• Breach of confidentiality 
• Incarceration of a participant when the research was not previously approved under Subpart C 
and the investigator believes it is in the best interest of the subject to remain on the study. 
• New Information indicating a change to the risks or potential benefits of the research, in 
terms of severity or frequency. (e.g. analysis indicates lower-than-expected response rate or a 
more severe or frequent side effect; Other research finds arm of study has no therapeutic value; 
FDA labeling change or withdrawal from market) 
 
Reporting Process 
The reportable events noted above will be reported to the IRB using the form: “Reportable Event Form” or 
as a written report of the event (including a description of the event with information regarding its 
fulfillment of the above criteria, follow-up/resolution and need for revision to consent form and/or other 
study documentation). 
 
Copies of each report and documentation of IRB notification and receipt will be kept in the Clinical 
Investigator’s study file. 
8.3 Unblinding Procedures 
 
Because of the low side-effect profile for this study it will not be necessary to unblind subjects for any 
particular reason unless they want to be withdrawn from the study and informed of what drug was given to 
them. If this were to occur the investigator must inform the sponsor-investigator of all subjects whose 
treatment was unblinded immediately within 24 hours by phone or fax, followed by a written narrative of the 
event within 48 hours.  

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8.4 Medical Monitoring 
It is the responsibility of the Principal Investigator and Study Regulatory Sponsor to oversee the safety of 
the study.  This safety monitoring will include careful assessment and appropriate reporting of adverse 
events as noted above. Medical monitoring will include a regular assessment of the number and type of 
serious adverse events.  A full Data and Safety Monitoring Plan is attached. 
9 Data Handling and Record Keeping 
9.1 Confidentiality and HIPAA 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  In addition to the data security 
standards noted below, we will also required a signed subject authorization (incorporated into the study 
consent form) informing the subject of the following:  
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information  
• The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study 
period. 
9.2 Source Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in 
source documents.  Examples of these original documents, and data records include: hospital records, 
clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm 
or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial. 
9.3 Study Records 
The study records will collect the primary data collection instrument for the study.  All data required by the 
protocol must be recorded.  All missing data must be explained.  Study records will be maintained in a 
secure area accessible to the Principal Investigator and study staff. 
9.4 Study Electronic Data 
Data will be maintained on a database on a computer which the investigators of this study as well as 
research assistants have access (however not everyone will see the data due to blinding of the physicians 
involved in the study). The data will be kept on an NYU research network drive that is password protected. 
If the data is shared among the investigators it will also be emailed within the NYU email system which is 
also password protected and encrypted. 
 
All data will be stored for future use. It will take approximately 1-2 years to obtain the number of patients 
required for the trigger finger arm of the study due to the multitude of patients requiring trigger finger 
injections in everyday practice. However, it can take longer for the other arms of the study to collect the 
required amount of patients. The following list explains how this long term data will be handled: 
- 
Data will contain patient names abbreviated with initials of first and last names as well as medical 
record numbers attached in order to easily obtain more information on the patient in the hospital 
electronic medical record (EMR) 

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- 
Data will be stored indefinitely until it is determined that enough data has been obtained to 
publish results.  
- 
Data will be kept on an NYU research network drive that the department of hand surgery 
maintains and is password protected. The resident investigator of this study along with hand 
department research assistants will have access to the data however any physicians involved in 
the treatment of these patients will not be able to see the data for blinding purposes.  
- 
Data stored for future use will continue to be maintained in the event a retrospective review of the 
data is conducted (pending an IRB approval for this as well). At this time it is unknown what this 
data can also be used for aside from the primary purpose of the study. 
- 
Once the study is complete the results will be shared among physicians. A subject’s research 
data will be provided to subjects upon request. Patient will only be told their personal data 
outcomes and the general outcomes of the study as a whole however other patient information 
will be kept from them as per patient confidentiality rules. 
- 
Storage for future use is not optional. This data needs to be stored because it can be used for 
other research in the future (retrospective reviews, etc). 
9.5 Records Retention 
Study source information collected in the EPIC system will be maintained according to institutional 
standards (and a least 6 years) and other study essential documents will be maintained for a minimum of 
6 years after completion of the study and analysis of the study data.  
10 Study Monitoring, Auditing, and Inspecting 
10.1 Study Monitoring  
For full details on study data and safety monitoring, see the accompanying Data and Safety Monitoring Plan 
for this study.  The responsibility for gathering the data will rest with the individual investigators/health care 
providers that are directly treating the patients (either at the NYU HJD hand clinic on 23rd street or in the 
private office of hand attending). Individuals treating patients will be informed to relay any unanticipated 
problems/concerns/adverse events to the resident research coordinator (Sergio Glait, MD). Data will be 
consolidated and sent to the resident researcher for further evaluation and for monitoring during the course 
of each patient’s length of treatment.  
 
The resident research coordinator (Sergio Glait, MD) will ensure data accuracy by monthly asking how the 
data was collected and ensuring individuals are following proper protocol. In addition, data accuracy will 
also be maintained with quick training sessions on the study to be conducted at the study site once every 
2 month basis. This will be done by the hand research coordinators/assistants, the resident researchers, or 
the principal investigators/attending involved.  Monitoring work will be reviewed at regular intervals with the 
study Principal Investigator. 
 
Patients that ultimately drop out of the study will be monitored for the course of their regularly scheduled 
follow-up appointments until there are discharged from the clinic or the care of the attending orthopaedic 
hand surgeon. 
 
Primary and secondary efficacy endpoints will be monitored. Either patients will have resolution of their 
symptoms (primary endpoint) with improvement in hand function to their desired satisfaction or they must 
undergo surgery (secondary endpoint) for correction due to failure of the local soft tissue injection in 
relieving their symptoms. 

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10.2 Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, government 
regulatory bodies, and University compliance and quality assurance groups of all study related 
documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-related facilities (e.g. 
pharmacy, diagnostic laboratory, etc.). 
11 Ethical Considerations 
This study is to be conducted accordance with applicable US government regulations and international 
standards of Good Clinical Practice, and applicable institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted Institutional Review Board 
(IRB) in agreement with local legal prescriptions, for formal approval of the study conduct.  The decision of 
the IRB concerning the conduct of the study will be made in writing to the investigator and a copy of this 
decision will be provided to the sponsor before commencement of this study.   
 
All subjects for this study will be provided a consent form describing this study and providing sufficient 
information for subjects to make an informed decision about their participation in this study. This consent 
form will be submitted with the protocol for review and approval by the IRB for the study.  The formal consent 
of a subject, using the IRB/EC-approved consent form, must be obtained before that subject undergoes 
any study procedure.  The consent form must be signed by the subject or legally acceptable surrogate, and 
the investigator-designated research professional obtaining the consent.  
12 Study Finances 
12.1 Funding Source 
This study is funded by the Department of Orthopaedic Surgery. 
12.2 Conflict of Interest 
The NYULMC Investigator, Sub-investigators, and study staff will follow the applicable University conflict 
of interest policies. 
12.3 Subject Stipends or Payments 
There are no subject stipends or payments for participation in this study. 
13 Publication Plan 
Once data is complete and analyzed by our institution’s statisticians we will plan to submit the study for 
publication within approximately 3 months of the completion of the study. The primary responsibility for 
the publication of the results of the study lies with the principal investigator Dr. Anthony Sapienza. 
 
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