Clinical trial NCT02421419
Conditions: Trigger Finger Disorder
Keywords: flexor tendon entrapment snapping finger trigger digits trigger thumb
Sponsor: Kenneth Taylor, M.D.
Start date: 2015-06-01; Completion date: 2017-01-25
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Detailed description:
This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Arms: arm 1: 1 cc dexamethasone sodium phosphate (4mg/ml) injectable arm 2: 1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable arm 3: 1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Interventions: intervention 1: Dexamethasone Sodium Phosphate intervention 2: Xylocaine intervention 3: Sodium Chloride
Intervention descriptions: intervention 1: adreno-cortical steroid anti-inflammatory drug intervention 2: a local anesthetic agent intervention 3: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment

Protocol documents:
Prot_SAP_000.pdf: 
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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
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CONSENT FOR RESEARCH
Penn State College of Medicine
The Milton S. Hershey Medical Center
Title of Project:  Pain with trigger finger injection: A comparison of steroid alone versus steroid/lidocaine 
mixture
Principal Investigator: Kenneth Taylor, M.D.
Address: Penn State Milton S. Hershey Medical Center, Bone & Joint Institute, 30 Hope Drive, EC089, PO 
Box 859, Hershey, PA  17033
Telephone Numbers: Weekdays: 8:00 a.m. to 4:30 p.m. (717) 531-5638; After hours and weekends:  
(717) 531-8521 (ask for the orthopaedic resident on 24-hour call)
Subject’s Printed Name: _____________________________
We are asking you to be in a research study.
Whether or not you take part is up to you. You can choose not to take part. You 
can agree to take part and later change your mind. Your decision will not be held 
against you.
This form gives you information about the research. Please ask questions about 
anything that is unclear to you and take your time to make your choice.
1.   Why is this research study being done?   
We are asking you to be in this research study because you have a condition in your finger called 
trigger finger.  Trigger finger is a condition that affects the tendons in your fingers or thumb.
This research is being done to compare pain relief and efficacy of trigger finger injection using a 
combination of lidocaine/corticosteroid versus corticosteroid injection alone or corticosteroid/saline 
combination.  
Approximately 221 people will take part in this research study at Hershey Medical Center. 
2.   What will happen in this research study? 
After you have read through this consent form, all of your questions have been answered to your 
satisfaction, and you have agreed to participate by signing this form, it will be determined by reviewing 
your medical history if you meet all of the criteria to participate in the study.
If you are eligible to be in the study, you will be randomized (assigned at random, like flipping a coin) 
to one of three study groups:

CS - corticosteroid alone

CSL – corticosteroid/lidocaine combination

CSS – corticosteroid/saline combination
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All treatment drugs are FDA approved and considered standard of care.
Randomization means that neither you nor your study doctor will choose what group you will be in.  You 
will have an equal (1 out of 3) chance of being placed in any one of the three groups.  You will not know 
which treatment group you have been randomized to (this is called blinding).  This is used to decrease the 
amount of bias in a study.  
The study investigator will perform a single injection under your skin into the joint surrounding your 
finger.  One minute after the injection, you will complete a Patient Survey to assess your pain level and 
whether and how often you trigger (snap).  Ten minutes after that, you will complete another Patient 
Survey.  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 
your routine standard of care.
You will receive a telephone call from the study doctor or member of his team six weeks following your 
injection. The telephone call should take about 10 minutes. The purpose of this call is to see how your 
hand is doing as well as have you complete the Patient Survey.  
What are my responsibilities if I take part in this research? 
If you take part in this research, your major responsibilities will include: 

Completing the Patient Survey during your visit.

Allowing a member of the research team to contact you via phone six weeks post-injection visit.  
During that phone call, you will be asked questions about how your hand is doing and you will 
need to complete a Patient Survey verbally on the phone.

You do not have to be in this research. 

If you choose to be in this research, you have the right to stop at any time. 

If you decide not to be in this research or if you decide to stop at a later date, there will be no 
penalty or loss of benefits to which you are entitled. 
3.   What are the risks and possible discomforts from being in this research 
study?  
There is a risk of loss of confidentiality if your medical information or your identity are obtained by 
someone other than the investigators, but precautions will be taken to prevent this from happening.
You will be assigned to a treatment program by chance. The treatment you receive may prove to be less 
effective or to have more side effects than the other research treatment(s) or other available treatments.
There is a risk of allergic reaction to lidocaine or the preservative used in lidocaine.
There is risk of some pain and discomfort with the injection as well as the possibility of nerve damage 
(numb finger) for a period of time after the injection.
4.   What are the possible benefits from being in this research study?   
4a.  What are the possible benefits to me?
You likely will not benefit from this particular research study; however, the treatment group that 
you are assigned to could be more beneficial than another in providing you pain relief.  
 
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4b. What are the possible benefits to others? 
The results of this study may guide future treatment decisions.
 
5.   What other options are available instead of being in this research study?
You do not have to take part in this study to be treated for your condition. Instead of participating in this 
research, you could:

Receive standard of care treatment only.  

Be part of a different research study, if one is available.
Before you decide if you want to be in this research, we will discuss the choices that are available to you. 
We will tell you about the possible benefits and risks of these choices.
6.   How long will I take part in this research study?
If you agree, you will be in the research study for six weeks. You will not need to return to the 
research site again but will need to allow a member of the research team to contact you via phone six 
weeks following your injection.
7.   How will you protect my privacy and confidentiality if I decide to take part in this 
research study?
7a.  What happens to the information collected for the research?
Efforts will be made to limit the use and sharing of your personal research information. In our research 
files at The Milton S. Hershey Medical Center (HMC) and Penn State College of Medicine (PSU) we 
will include these identifiers:  your name, medical record number, phone number, and a code number.

A list that matches your name with your code number will be kept in a locked file in Dr. Taylor’s 
research office.

Your research records will be labeled with your code number and kept in a safe area in Dr. Taylor’s 
research office.

A copy of this signed consent form will be included in your HMC medical record. This means that 
other HMC healthcare providers will know you are in this study. 
In the event of any publication or presentation resulting from the research, no personally identifiable 
information will be shared.
7b. How will my identifiable health information be used?
If you give your consent, health information that can be traced to you will be collected for this research 
study. In general, under federal law, health information is private. However, there are exceptions to this 
rule, and you should know who may be able to see, use, and share your health information for research 
and why they may need to do so. 
The research team may use the following health information:

Past, present, and future medical records

New health information from tests, procedures, visits, interviews, or forms filled out as part of 
this research study.
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The following people/groups may see, use, and share your identifiable health information:

HMC/PSU research staff involved in this study

The HMC/PSU Institutional Review Board (IRB), a group of people who review the research 
study to protect subjects’ rights and welfare

The HMC/PSU Human Subjects Protection Office

The HMC/PSU Research Quality Assurance Office

Non-research staff within HMC/PSU who need this information to do their jobs (such as for 
treatment, payment (billing), or health care operations)

Federal and state agencies (such as the U.S. Food and Drug Administration, the Office for 
Human Research Protections, the Department of Health and Human Services, the National 
Institutes of Health, and other U.S. or foreign government bodies that oversee or review 
research)

The HMC/PSU pharmacy

Organizations that provide independent accreditation and oversight of hospitals and research

Public health and safety authorities (for example, if we learn information that could mean harm 
to you or others, we may need to report this, as required by law)
These groups may also review and/or copy your original PSU/HMC records while looking at the results 
of the research study.  It is possible that some of the other people/groups who receive your health 
information may not be required by Federal privacy laws to protect your information. We share your 
information only when we must, and we ask anyone who receives it from us to protect your privacy. 
Because research is an ongoing process, your permission for the use, storage and sharing of your health 
information will continue indefinitely. 
Your privacy rights:

You have the right to refuse to sign this form that allows us to use and share your health 
information for research; however, if you don’t sign it, you will not be able to take part in this 
research study.

You have the right to withdraw your permission for us to use or share your health information 
for this research study. If you want to withdraw your permission, you must notify the person in 
charge of this research study in writing using the address on the front of this form. Once 
permission is withdrawn, you cannot continue to take part in the study. 

If you withdraw your permission, we will stop collecting health information about you for this 
study; we may continue to use and share your health information that we already have if it is 
necessary for safety and scientific soundness of the research study; and we will not be able to 
take back information that has already been used or shared with others. 

You have the right to see and get a copy of your health information that is used or shared for 
treatment or for payment. However, you may not be allowed to see or copy certain health 
information that is a part of this research study. This is only for the period of the study. You will 
be allowed to see that information when the entire research study is complete. 
          
8.   What are the costs of taking part in this research study?
8a. What will I have to pay for if I take part in this research study? 
For costs of medical services for care you would receive even if you were not in this research study:

You and/or your insurance company will be responsible for the cost of routine medications, tests 
and procedures that you would receive even if you were not in this research.

You and/or your insurance company will be billed for the costs of these routine tests and 
procedures in the usual manner.
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
You will be responsible for any co-payments, co-insurance and deductibles that are standard for 
your insurance coverage. 

You will be responsible for any charges not reimbursed by your insurance company.

Some insurance companies will not pay for routine costs for people taking part in research 
studies. Before deciding to be in this research you should check with your insurance company to 
find out what they will pay for.
If you have any questions about costs and insurance, ask the research study doctor or a member of the 
research team. 
8b. What happens if I am injured as a result of taking part in this research 
study?
It is possible that you could develop complications or injuries as a result of being in this research study. If 
you experience a side effect or injury and emergency medical treatment is required, seek treatment 
immediately at any medical facility. If you experience a side effect or injury and you believe that 
emergency treatment is not necessary, you should contact the principal investigator listed on the first 
page of this consent form as soon as possible and he/she will arrange for medical treatment.
HMC/PSU compensation for injury

There are no plans for HMC/PSU to provide financial compensation or free medical treatment 
for research-related injury. 

If an injury occurs, medical treatment is available at the usual charge. 

Costs will be charged to your insurance carrier or to you. 

Some insurance companies may not cover costs associated with research injuries. 

If these costs are not covered by your insurance, they will be your responsibility.
When you sign this form you are not giving up any legal right to seek compensation for 
injury.
 
9. Will I be paid to take part in this research study? 
You will not receive any payment or compensation for being in this research study.
10. Who is paying for this research study? 
The institution and investigators are not receiving any funds to support this research study.         
11. What are my rights if I take part in this research study? 
Taking part in this research study is voluntary. 

You do not have to be in this research. 

If you choose to be in this research, you have the right to stop at any time. 

If you decide not to be in this research or if you decide to stop at a later date, there will be no 
penalty or loss of benefits to which you are entitled. 
If you stop being in the research, already collected data may not be removed from the study database. 
You will be asked whether the investigator can collect medical information from your routine medical 
care. If you agree, this data will be handled the same as research data. If you withdraw completely from 
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the research study, no further information will be collected and your participation will end. You may 
discontinue taking part at any time without penalty or loss of benefits to which you are otherwise entitled. 
Your research doctor may take you out of the research study without your permission. 

Some possible reasons for this are: continuing the research would be harmful, your condition 
has become worse, you become pregnant, you did not follow the instructions of the study 
doctor, you experience serious side effects

If your participation ends early, you may be asked to visit the research doctor for a final visit. 
If you will be in another clinical research study at Hershey Medical Center or elsewhere while in this 
research, you should discuss the procedures and/or treatments with your physician or the study 
doctors. This precaution is to protect you from possible side effects from interactions of research 
drugs, treatments or testing.
During the course of the research you will be provided with any new information that may affect your 
health, welfare or your decision to continue participating in this research.
12. If I have questions or concerns about this research study, whom should I call?    
Please call the head of the research study, Dr. Kenneth Taylor at 717-531-8521 or the orthopedic surgery 
doctor on 24-hour call if you:

Have questions, complaints or concerns about the research.

Believe you may have been harmed by being in the research study.  
You may also contact the research protection advocate in the HMC Human Subjects Protection Office 
(HSPO) at 717-531-5687 if you:

Have questions regarding your rights as a person in a research study.

Have concerns or general questions about the research. 

Have questions about your privacy and the use of your personal health information. 

You may also call this number if you cannot reach the research team or wish to talk to someone 
else about any concerns related to the research. 
You may visit the HSPO’s web site at http://pennstatehershey.org/irb under subject information for:
Information about your rights when you are in a research study; 
Information about the Institutional Review Board (IRB), a group of people who review the 
research to protect your rights; and 
Links to the federal regulations and information about the protection of people who are in 
research studies. If you do not have access to the internet, copies of these federal regulations are 
available by calling the HSPO at (717) 531-5687.
A description of this clinical trial will be available at http://www.ClinicalTrials.gov, as required by U.S 
Law.  This web site will not include information that can identify you. At most, the web site will include 
a summary of the results.  You can search this web site at any time.
.
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INFORMED CONSENT AND AUTHORIZATION TO TAKE PART IN RESEARCH 
Signature of Person Obtaining Informed Consent
Your signature below means that you have explained the research to the subject or subject 
representative and have answered any questions he/she has about the research.
__________________________________
_________
______
_________________
Signature of person who explained this research
Date
Time
              Printed Name
(Only approved investigators for this research may explain the research and obtain informed consent.)  
Signature of Person Giving Informed Consent and Authorization
Before making the decision about being in this research you should have:

Discussed this research study with an investigator, 

Read the information in this form, and

Had the opportunity to ask any questions you may have. 
Your signature below means that you have received this information, have asked the questions you 
currently have about the research and those questions have been answered. You will receive a copy 
of the signed and dated form to keep for future reference.
Signature of Subject
By signing this consent form, you indicate that you voluntarily choose to be in this research and agree to 
allow your information to be used and shared as described above. 
___________________________
__________
______      
________________
 Signature of Subject 
Date
Time
Printed Name
Witness to Consent of Subjects Who Cannot Read or Write
Witness Statement: Your signature indicates that you were present during the informed consent discussion 
of this research for the above named subject, that the information in the consent form and any other written 
information was presented orally to the subject or subject representative, that he/she was given the 
opportunity to ask questions, that the informed consent decision was freely made by the subject or subject 
representative who indicated his/her consent and authorization for participation by (check the box as 
applicable):  
  Making his/her mark
  Other means: ____________________________________________________
(fill in above)
_______________________
__________
______      
____________________ 
Witness Signature  
Date
Time
Printed Name
 
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Approval End Date: 4/26/2016