Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture
Phase: PHASE4
Conditions: Trigger Finger Disorder
Sponsor: Kenneth Taylor, M.D.

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HRP-592 - Protocol for
Human Subject Research
with Use of Test Article(s)
Protocol Title: 
Pain with trigger finger injection: A comparison of steroid alone versus 
steroid/lidocaine mixture
Principal Investigator:
Kenneth Taylor, M.D.
Department of Orthopaedics
(717) 531-5638
ktaylor3@hmc.psu.edu
Version Date:
May 20, 2015
Clinicaltrials.gov Registration #:  NCT02421419
1.0
Objectives
1.1
Study Objectives 

Compare pain, using a visual analog scale (VAS), associated with corticosteroid/lidocaine injection 
(CSL) to corticosteroid injection alone (CS) and corticosteroid/saline (CSS) injection.

Review any adverse events related to the three treatment groups (CSL, CS and CSS).

Review the efficacy of the three treatment groups (CSL, CS and CSS).

Subcategorize patients based on demographic variables, comorbid conditions and anatomic location.
1.2
Primary Study Endpoints

Compare pain and efficacy associated with the three treatment groups.  
o
VAS and mean daily pain values
1.3
Secondary Study Endpoints 

Incidence of adverse effects

Presence of clicking/locking (yes/no)

Patient satisfaction (yes/no)

Time to stopping medication

Need for additional analgesics

Effectiveness of injection
2.0
Background 
2.1
Scientific Background and Gaps
Trigger finger, or stenosing tenosynovitis, is a condition in which the flexor tendon is prohibited from 
gliding through the tendon sheath because of thickening of the synovial sheath over the tendon.1 As a 
result, digital movement is impaired, and the affected digit locks in either flexion (the most common 
position) or extension, resulting in pain and swelling. Trigger digit pathology can be associated with 
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occupations involving lifting or gripping, but it also is associated with systemic disease states, such as 
rheumatoid arthritis and diabetes mellitus.2 Trigger finger has a reported incidence of 28 cases per
100,000 subjects annually, or a risk of 2.6% over a lifetime.3 A survey of 516 patients treated between 
1975 and 1994 indicated that 61% of trigger fingers occurred in women.4
Multiple approaches are available for both operative and non-operative management of trigger finger. 
Splinting, corticosteroids (either single or multiple injections), percutaneous surgery, and open surgery 
are all established means of treatment. A single injection of corticosteroid can provide symptom relief in 
47% to 87% of patients with trigger finger.7-11 According to Newport et al,13 each additional corticosteroid 
injection resulted in diminished efficacy. Corticosteroid injection has been widely accepted as first line 
treatment.8,9,14-16 When splinting and/or corticosteroid injections fail, surgery is recommended.14 
Lidocaine is commonly used in conjunction with a corticosteroid because of its local anesthetic effect and 
near-immediate relief of pain.  This dilution and increase in overall volume can aid in confirmation of 
medication delivery to the appropriate tissue and encourage diffusion of the steroid crystalline suspension 
to the entire area of interest.  Though corticosteroids have a relatively quick onset of action, it may take 
24 - 48 to notice symptom relief related to their prolonged anti-inflammatory effect, therefore lidocaine 
usually provides immediate, although, short-acting relief of pain.  Lidocaine is extremely painful upon 
injection and may be an unnecessary addition to the steroid suspension. Addition of lidocaine also 
increases the volume of the injection, which may be a source of pain upon deposition into the flexor 
tendon sheath and subcutaneous tissues of the finger. 
2.2
Previous Data
Previous studies have evaluated the efficacy of steroid injections as compared to placebo injections in the 
treatment of trigger finger but no previous studies have compared steroid/lidocaine injections to injections 
without lidocaine.  The aim of this study is to compare post-injection pain and efficacy of trigger finger 
injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone or 
corticosteroid/saline (equal volume). Our hypothesis is that lidocaine causes unnecessary pain upon 
injection and does not improve the efficacy of the steroid in providing sustained anti-inflammatory 
benefit.  We also seek to determine if volume of injection plays a role in immediate post-injection pain 
(corticosteroid/saline group). 
2.3
Study Rationale
See study objectives
3.0
Inclusion and Exclusion Criteria
3.1
Inclusion Criteria

Age: 18 – 90

Gender: male or female (non-pregnant)

Clinically diagnosed trigger digit

Subject is able to provide voluntary, written informed consent

Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and 
is willing to perform all study procedures and follow-up visits.
3.2
Exclusion Criteria

Age: <18 or >90

Pregnant or lactating women

Non-English speaking individuals

Medication contradictions to lidocaine, corticosteroids and/or saline 

History of multiple drug allergies

Prior injection or surgery on the affected finger

Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS)

Open wound
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
Inability to provide informed consent
3.3
Early Withdrawal of Subjects
3.3.1
Criteria for removal from study
Patients will be withdrawn from the study for safety reasons including severe adverse reactions, 
failure of subject to adhere to protocol requirements, or subject consent withdrawal.
3.3.2
Follow-up for withdrawn subjects
If a patient is withdrawn from the study, data collection will be terminated from that time point 
forward.  All prior data collected will be included in the analysis.  These subjects will not be 
replaced, but instead more subjects may need to be enrolled.  These new data will be recorded 
and analyzed as would any other new enrollee.  No further follow-up of withdrawn subjects is 
necessary.
4.0
Recruitment Methods
4.1
Identification/Recruitment of subjects
Subjects will be identified as part of their initial or routine evaluation by one of the study investigators in 
the Bone & Joint Institute.  
4.2
Recruitment materials – N/A
4.3
Eligibility/screening of subjects
Adult patients presenting to the Bone & Joint Institute will be evaluated as part of standard of care.  Those 
subjects meeting eligibility requirements will be presented with the opportunity to participate in the 
research study by a member of the research team.
5.0
Consent Process and Documentation 
5.1
Consent Process 
. 
5.1.1
Obtaining Informed Consent
5.1.1.1
Timing and Location of Consent
Subjects presenting to the study investigator’s practice site as part of their initial 
or routine evaluation will be given the opportunity to participate in the research 
study.  Patients will be given information about the study and asked to 
participate.  If eligible, based on inclusion and exclusion criteria, informed 
consent will be obtained at the time of the screening visit and the patient will be 
enrolled in the study.
5.1.1.2
Coercion or Undue Influence during Consent
Subjects will be given ample time to read and review the consent form on their 
own.  All questions the patient may have will be answered and written consent 
will be obtained.  A member of the research team will assist in the explanation 
and obtaining of the written consent.  A copy of the signed consent will be given 
to the patient and another copy sent to Medical Records.
5.1.2
Waiver or alteration of the informed consent requirement – N/A
5.2
Consent Documentation
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5.2.1
Written Documentation of Consent
A member of the research team will assist in the explanation and obtaining of the written consent.  
A copy of the signed consent will be given to the patient and another copy sent to Medical 
Records.
5.2.2
Waiver of Documentation of Consent – N/A
5.3
Consent – Other Considerations 
5.3.1
Non-English Speaking Subjects – N/A
5.3.2
Cognitively Impaired Adults - N/A
5.3.2.1 Capability of Providing Consent - N/A
5.3.2.2 Adults Unable To Consent - - N/A
5.3.2.3 Assent - N/A
5.3.3
Subjects who are not yet adults (infants, children, teenagers) 
5.3.3.1 Parental Permission - N/A
5.3.3.2 Assent – N/A
6.0
HIPAA Research Authorization and/or Waiver or Alteration of 
Authorization
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures 
of PHI
Check all that apply:
Authorization will be obtained and documented as part of the consent process.
Partial waiver is requested for recruitment purposes only (Check this box if patients’ 
medical records will be accessed to determine eligibility before consent/authorization 
has been obtained)
Full waiver is requested for entire research study (e.g., medical record review studies) 
Alteration is requested to waive requirement for written documentation of authorization
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
6.2.1
Access, use or disclosure of PHI representing no more than a minimal risk to the 
privacy of the individual
6.2.1.1 Plan to protect PHI from improper use or disclosure
Information is included in Section 10 of this protocol
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers 
The list will be destroyed upon completion of the study.
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6.2.2
Explanation for why the research could not be practicably be conducted without 
access to and use of PHI
Patient identifiers are necessary for identification and review of the patient’s medical records.  A 
unique study code number will be used for identification of study data.  The linking list will be 
destroyed upon completion of the study.
6.2.3
Explanation for why the research could not practicably be conducted without the 
waiver or alteration of authorization – N/A
6.3
Waiver or alteration of authorization statements of agreement
Protected health information obtained as part of this research will not be reused or disclosed to any other 
person or entity, except as required by law, for authorized oversight of the research study, or for other 
permitted uses and disclosures according to federal regulations.
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) per 
federal regulations. 
Access to the information will be limited, to the greatest extent possible, within the research team. 
All disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented. 
7.0
Study Design and Procedures
7.1
Study Design 
This will be a prospective, randomized, double-blind study in which patient and data collector is blinded 
to the treatment protocol.  The physician who is preparing and performing the injection will remain 
unblinded.
Recruitment  Randomization  Treatment (Corticosteroid v corticosteroid/lidocaine v 
corticosteroid/saline)
Corticosteroid (CS)  post-injection assessment immediately following injection  post-injection 
assessment at 6 weeks (via phone)
Corticosteroid/lidocaine (CSL) combination  post-injection assessment immediately following 
injection  post-injection assessment at 6 weeks (via phone)
Corticosteroid/saline (CSS) combination  post-injection assessment immediately following injection  
post-injection assessment at 6 weeks (via phone)
7.2
Study Procedures
7.2.1
Visit 1 – Screening/Baseline Visit
Patients will be given information about the study and asked to participate.  If eligible, based on 
inclusion and exclusion criteria, informed consent will be obtained at the time of the screening 
visit and the patient will be enrolled in the study.  
After obtaining informed consent, the patient will be randomized to one of three treatment 
groups.  The study investigator (who is unblinded) will randomly draw a sealed envelope 
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containing one of the three treatment groups.  The sealed envelopes will be stored in a secure area 
within the clinic practice site.

CS – corticosteroid alone -1 cc dexamethasone (4mg/ml) only

CSL – corticosteroid/lidocaine combination - 1 cc dexamethasone (4mg/ml) and 1 cc 1% 
lidocaine

CSS – corticosteroid/saline combination - 1 cc dexamethasone (4mg/ml) and 1 cc 0.9% 
injectable saline)
The patient will then be asked to complete a Patient Survey pre-injection (VAS Pain Scale and 
Trigger question).  The study investigator will perform a single injection using a 25 gauge 1.5” 
needle.  The needle will be inserted at 90 degrees to the skin, 1 cm proximal to the 
metacarpophalangeal joint flexion crease.  The injections will be prepared in the Bone & Joint 
Institute as part of standard of care.
The patient will then complete the Patient Survey at 1 minute and 10 minutes following injection 
(VAS Pain Scale and Trigger question).
Objective hand exam will be performed including range of motion at MP, PIP and DIP joints, 
presence of clicking or locking, triggering score, pain with range of motion and grip strength as 
part of the patient’s standard of care.
7.2.2
6-Week Follow-Up Phone Call
 
The patient will be contacted via phone and will be asked to verbally complete the Patient Survey 
(patient will be asked to report the VAS Pain score over the phone in .5 increments – i.e. 3.5, 4.0, 
5.0, 5.5, etc.) and the coordinator will record the score.  The patient will also answer question 
about how often he/she triggers (see phone script).
7.2.3
Study Visit Flowsheet
Screening Visit – Visit 1
6-Week Follow-Up – Phone Call
Enrollment, Randomization, Pre-injection VAS,  
Injection, Post-injection VAS x 2, 
objective hand exam (SOC)
VAS, trigger question
7.3
Duration of Participation
Subjects will only be seen in the clinic site once (time of enrollment in study) and will be contacted via 
telephone six weeks post-injection.
7.4
Test Article(s) (Study Drug(s) and/or Study Device(s))
7.4.1 Description
The study drugs consist of the following:

CS – corticosteroid alone -1 cc dexamethasone (4mg/ml) only

CSL – corticosteroid/lidocaine combination - 1 cc dexamethasone (4mg/ml) and 1 cc 1% 
lidocaine

CSS – corticosteroid/saline combination - 1 cc dexamethasone (4mg/ml) and 1 cc 0.9% 
injectable saline)

All of these drugs are currently FDA approved and considered standard of care.
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7.4.2 Treatment Regimen
The study investigator will perform a single injection using a 25 gauge 1.5” needle.  The needle 
will be inserted at 90 degrees to the skin, 1 cm proximal to the metacarpophalangeal joint flexion 
crease.
7.4.3 Method for Assigning Subject to Treatment Groups
Patients will be randomized to receive CS, CSL, or CSS during their clinic visit.  
7.4.4 Subject Compliance Monitoring
After obtaining informed consent, patients will be randomized to one of three recruitment groups.  
They will then be asked to complete a Patient Survey pre-injection and again 1 minute and 10 
minutes after injection.  They will be contacted via phone at six weeks post-injection and asked to 
verbally complete the Patient Survey.
7.4.5 Blinding of the Test Article
The three drug combinations will be compounded in the Bone & Joint Institute as part of routine 
standard of care.  
7.4.6
Receiving, Storage, Dispensing and Return 
7.4.6.1
Receipt and Storage of Test Article 
The compounds will be stored at room temperature in the Bone & Joint Institute.  
These injections are routine standard of care and all policies regarding receipt, 
storage, dispensing and disposing will be strictly followed.
7.4.6.2
Preparation and Dispensing
Subject randomization will be performed prior to dispensing of any study drugs.  
After randomization, subjects will be dispensed study drugs as follows:

CS – corticosteroid alone -1 cc dexamethasone (4mg/ml) only

CSL – corticosteroid/lidocaine combination - 1 cc dexamethasone 
(4mg/ml) and 1 cc 1% lidocaine

CSS – corticosteroid/saline combination - 1 cc dexamethasone (4mg/ml) 
and 1 cc 0.9% injectable saline)
7.4.6.3
Return or Destruction of the Test Article
The study drug will be disposed of in clinic following standard procedure for 
disposal of needles.
7.4.6.4
Prior and Concomitant Therapy
See exclusion criteria
8.0
Data and Specimen Banking For Future Undetermined Research
8.1
Data and/or specimens being stored – N/A
8.2
Location of storage – N/A
8.3
Duration of storage – N/A
8.4
Access to data and/or specimens – N/A
8.5
Procedures to release data or specimens – N/A
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8.6
Process for returning results– N/A
9.0
Statistical Plan
9.1
Sample size determination
Sample size was determined based on a review of prior studies that used the VAS as the main outcome 
tool.  A total sample size of 221 was determined based on the number needed to detect a difference of 5 
mm assuming a standard deviation of 10 mm in the VAS and when also considering a 15 % drop out rate.  
221 total patients initially enrolled in the study would account for 64 patients per treatment arm 
(Corticosteroid only v corticosteroid/lidocaine v corticosteroid/saline).  Public Health Sciences will be 
ensuring accuracy of statistical analyses.  Stratification based on perioperative variables of interest will 
not be necessary in our study.  Instead, we will be analyzing these variables via subgroup multivariate 
analyses at the conclusion of the study.
9.2
Statistical methods
The daily average pain score (VAS) will be compared between groups using either t-test or Wilcoxon test 
for each of the 6 days after the operation.  Chi-square tests will be used to compare treatment groups for 
categorical variables (satisfaction, presence of clicking/locking, adverse events).  Level of significance 
will be set at p < 0.05.
Secondary statistical analysis will include multivariate analyses to determine which variables such as 
anatomic location and comorbidities will impact the VAS score or modify the efficacy of injection. These 
can be accomplished by adding these variables and their interaction with treatment groups in the 
regression model. As these are secondary analysis, any interesting findings will be subject to validation in 
future studies.  
Any deviations from the previously described statistical plan will be described and justified in a protocol 
amendment.
All analyses comparing the treatment groups will be conducted on an intention-to-treat basis.  Two-tailed 
tests will be used at all times.
There will be an interim analysis when 50 % of patients (n=111) are enrolled and have completed final 
visit testing.
10.0 Confidentiality, Privacy and Data Management 
10.1
Confidentiality
10.1.1 Identifiers associated with data and/or specimens
See the Research Data Plan Review Form 
10.1.1.1
Use of Codes, Master List
See the Research Data Plan Review Form 
10.1.2 Storage of Data and/or Specimens
See the Research Data Plan Review Form 
10.1.3 Access to Data and/or Specimens
See the Research Data Plan Review Form 
.
10.1.4 Transferring Data and/or Specimens
See the Research Data Plan Review Form 
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10.2
Privacy
See the Research Data Plan Review Form 
11.0 Data and Safety Monitoring Plan
11.1
Periodic evaluation of data
The research coordinator will complete the appropriate report form and logs; assist the principal 
investigator to prepare reports and notify the IRB and any applicable reporting agencies of all 
unanticipated problems / adverse events.
The research coordinator and principal investigator will confirm that all adverse events are correctly 
entered in the AE log; be available to answer any questions concerning AEs; notify the IRB and any 
applicable reporting agencies of unanticipated problems and AEs as appropriate.  All assessments of AEs 
will be made by a licensed medical professional who is an investigator on the research.
11.2
Data that are reviewed 
Data to be reviewed includes the VAS scale as well as incidence of adverse effects, and patient 
satisfaction.
11.3
Method of collection of safety information
Data will be collected beginning after informed consent at time of enrollment through six weeks 
postoperatively. Data will be collected at the initial clinic visit and again via telephone six weeks post-
injection.  Adverse events will be collected as they occur.
11.4
Frequency of data collection
Data will be collected beginning after informed consent at time of enrollment through six weeks 
postoperatively. 
11.5
Individual’s reviewing the data
All data will be reviewed by members of the research team at completion of study.  Reporting of any 
adverse events will be reviewed as they occur.
11.6
Frequency of review of cumulative data
There will be an interim analysis in this study after 50% of patients are enrolled and have completed all 
study requirements. Adverse events will be reviewed as they occur.
11.7
Statistical tests
See statistical plan.
11.8
Suspension of research
There will be no stopping rules in this study as all medications are FDA approved and safe for patient use.  
If a patient, at any point in the course of their treatment demonstrates a significant adverse event related to 
the study medication, then the adverse event will be addressed.
12.0 Risks
Loss of confidentiality will be minimized as the research team will only have access to the research data and 
all information will be kept on a password-protected computer or in a locked filing cabinet.
Subjects will be assigned to a treatment program by chance. The treatment received may prove to be less 
effective or to have more side effects than the other research treatment(s) or other available treatments.  
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Allergic reaction to lidocaine or the preservative used in lidocaine.
Nerve damage for a period of time after the injection.
13.0 Potential Benefits to Subjects and Others
13.1
Potential Benefits to Subjects
The treatment received may prove to be less or more effective or to have more side effects than the other 
research treatment or other available treatments.
13.2
Potential Benefits to Others
The results of this study will guide future treatment decisions.
14.0 Sharing Results with Subjects – N/A
15.0 Economic Burden to Subjects
15.1
Costs 
All procedures are standard of care.
15.2
Compensation for research-related injury
It is the policy of the institution to provide neither financial compensation nor free medical treatment for 
research-related injury. In the event of injury resulting from this research, medical treatment is available 
but will be provided at the usual charge. Costs for the treatment of research-related injuries will be 
charged to subjects or their insurance carriers. 
16.0 Number of Subjects
Approximately 222 people (74 per treatment arm) will be enrolled in this research study at the Hershey Medical 
Center.
17.0 Resources Available
17.1
Facilities and locations
Penn State Milton S. Hershey Medical Center
17.2
Feasibility of recruiting the required number of subjects – N/A
17.3
PI Time devoted to conducting the research
Sufficient time will be devoted to conducting the research and reviewing the data
17.4
Availability of medical or psychological resources – N/A
17.5
Process for informing Study Team
All team members have been given copies of all IRB approved documents – protocol, data collection 
tools, approval memos, etc.  The team meets regularly to review data and any updates.
18.0 Other Approvals
This study was approved by the PSHMC Scientific Review Committee on 3/4/2015 prior to IRB submission.
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19.0 Subject Stipend (Compensation) and/or Travel Reimbursements
N/A
20.0 Multi-Site Research – N/A
20.1
Communication Plans – N/A
20.2
Data Submission and Security Plan – N/A
20.3
Subject Enrollment – N/A
20.4
Reporting of Adverse Events and New Information – N/A
20.5
Audit and Monitoring Plans – N/A
21.0 Adverse Event Reporting
21.1
Adverse Event Definitions
Adverse event
Any untoward medical occurrence associated with the use of the drug in humans, 
whether or not considered drug related
Adverse reaction
Any adverse event caused by a drug
Suspected 
adverse reaction
Any adverse event for which there is a reasonable possibility that the drug caused 
the adverse event.  Suspected adverse reaction implies a lesser degree of 
certainty about causality than “adverse reaction”.

Reasonable possibility.  For the purpose of IND safety reporting, 
“reasonable possibility” means there is evidence to suggest a causal 
relationship between the drug and the adverse event.
Serious adverse 
event or Serious 
suspected 
adverse reaction
Serious adverse event or Serious suspected adverse reaction: An adverse event 
or suspected adverse reaction that in the view of either the investigator or 
sponsor, it results in any of the following outcomes: Death, a life-threatening 
adverse event, inpatient hospitalization or prolongation of existing hospitalization, 
a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, or a congenital anomaly/birth defect. Important 
medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the patient or subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 
Life-threatening 
adverse event or 
life-threatening 
suspected 
adverse reaction
An adverse event or suspected adverse reaction is considered “life-threatening” if, 
in the view of either the Investigator (i.e., the study site principal investigator) or 
Sponsor, its occurrence places the patient or research subject at immediate risk of 
death.  It does not include an adverse event or suspected adverse reaction that 
had it occurred in a more severe form, might have caused death.
Unexpected 
adverse event or 
Unexpected 
suspected 
adverse reaction.  
An adverse event or suspected adverse reaction is considered “unexpected” if it is 
not listed in the investigator brochure, general investigational plan, clinical 
protocol, or elsewhere in the current IND application; or is not listed at the 
specificity or severity that has been previously observed and/or specified.
For device studies, incorporate the following definitions into the below 
responses, as written:
Unanticipated 
Any serious adverse effect on health or safety or any life-threatening problem or 
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adverse device 
effect
death caused by, or associated with, a device, if that effect, problem, or death was 
not previously identified in nature, severity, or degree of incidence in the 
investigational plan or IDE application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device 
that relates to the rights, safety, or welfare of subjects.
21.2
Recording of Adverse Events
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study team 
believed to be associated with the study drug will be followed until the event (or its sequelae) or the 
abnormal test finding resolves or stabilizes at a level acceptable to the investigator.
An abnormal test finding will be classified as an adverse event if one or more of the following criteria are 
met:

The test finding is accompanied by clinical symptoms

The test finding necessitates additional diagnostic evaluation(s) or medical/surgical intervention; 
including significant additional concomitant drug treatment or other therapy
Note: Simply repeating a test finding, in the absence of any of the other listed criteria, does not 
constitute an adverse event.  

The test finding leads to a change in study drug dosing or discontinuation of subject participation 
in the clinical research study

The test finding is considered an adverse event by the investigator.
21.3
Causality and Severity Assessments
The investigator will promptly review documented adverse events and abnormal test findings to 
determine 1) if the abnormal test finding should be classified as an adverse event; 2) if there is a 
reasonable possibility that the adverse event was caused by the study drug(s) or device(s); and 3) if the 
adverse event meets the criteria for a serious adverse event.
If the investigator’s final determination of causality is “unknown and of questionable relationship to the 
study drug(s) or device(s)”, the adverse event will be classified as associated with the use of the study 
drug(s) or device(s) for reporting purposes.  If the investigator’s final determination of causality is 
“unknown but not related to the study drug(s) or device(s)”, this determination and the rationale for the 
determination will be documented in the respective subject’s case history.
21.4
Reporting of Adverse Reactions and Unanticipated Problems to the FDA  
21.4.1 Written IND Safety Reports – N/A
21.4.2 Telephoned IND Safety Reports – Fatal or Life-threatening Suspected Adverse 
Reactions – N/A
21.5
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) experienced 
by a subject or other individual, which in the opinion of the investigator is determined to be (1) 
unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures.
21.6
Unblinding Procedures – N/A
21.7
Stopping Rules
There are no stopping rules in this study as all medications are FDA approved and safe for patient use.
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22.0 Study Monitoring, Auditing and Inspecting
22.1
Study Monitoring Plan
22.1.1Quality Assurance and Quality Control
Study data will be recorded and kept in the Research Coordinator’s office, on a password 
protected computer.  The Principal Investigator will oversee all aspects of the study.
22.1.2Safety Monitoring
The Principal Investigator will confirm that all adverse events (AE) are correctly entered into 
the AE case report forms by the coordinator; be available to answer any questions that the 
coordinators may have concerning AEs; and will notify the IRB, FDA, sponsor and/or DSMB of 
all applicable AEs as appropriate. All assessments of AEs will be made by a licensed medical 
professional who is an investigator on the research. 
The research coordinator will complete the appropriate report form and logs; assist the PI to 
prepare reports and notify the IRB, FDA, and/or DSMB of all Unanticipated Problems/SAE’s.
23.0 References
Saldana MJ: Trigger digits: Diagnosis and treatment. J Am Acad Orthop Surg 2001;9:246-252.
Wolfe SW: Tenosynovitis, in Green DP, Hotchkiss RN, Pederson WC, Wolfe SW (eds): Green’s Operative Hand 
Surgery, ed 5. Philadelphia, PA: Churchill Livingstone, 2005, 2137- 2158.
Strom L: Trigger finger in diabetes. J Med Soc N J 1977;74:951-954.
Kasdan ML, Leis VM, Lewis K, Kasdan AS: Trigger finger: Not always work related. J Ky Med Assoc 
1996;94:498- 499.
Marks MR, Gunther SF: Efficacy of cortisone injection in treatment of trigger fingers and thumbs. J Hand Surg 
[Am] 1989;14:722-727.
Lambert MA, Morton RJ, Sloan JP: Controlled study of the use of local steroid injection in the treatment of 
trigger finger and thumb. J Hand Surg [Br] 1992;17:69-70.
Murphy D, Failla JM, Koniuch MP: Steroid versus placebo injection for trigger finger. J Hand Surg [Am] 
1995;20:628-631.
Maneerit J, Sriworakun C, Budhraja N, Nagavajara P: Trigger thumb: Results of a prospective randomized study 
of percutaneous release with steroid injection versus steroid injection alone. J Hand Surg [Br] 2003;28: 586-589.
24.0 Appendix – N/A
STUDY00001858
Approval: 5/20/2015