Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty
Phase: PHASE2
Conditions: Trigger Point Pain, Myofascial
Sponsor: David Grant U.S. Air Force Medical Center

EIRB Protocol Template (Version 1.4)
1.0
General Information
*Please enter the full title of your protocol:
Trigger Point Injections in Reducing Pain Following Total Knee Arthroplasty
*Please enter the Protocol Number you would like to use to reference the protocol:
FDG20240079H
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify
this protocol.
Is this a multi-site protocol (i.e. Each site has their own Principal Investigator)?
No
Does this protocol involve the use of animals?
Yes
No
2.0
Add departments
2.1 List sites associated with this study:
Is 
Primary? Site Name
P and R - 60th Medical Group Clinical Investigation Facility (60th MDG)
3.0
Assign project personnel access to the project  
3.1 
Please add a Principal Investigator for the study:
*
Name
Role
Training Record
Bennett, Dustin 
Lansing
Principal 
Investigator
 View Training 
Record
Responsibility
Student
Site Chair
Resident
Fellow
3.2 If applicable, please select the Research Staff personnel: 
A) Additional Investigators
G
IRB approval date: 23 April 2025

Name
Role
Training Record
Dalessandro, Ashley Marie, Capt
Associate Investigator
 View Training Record
B) Research Support Staff 
Name
Role
Training Record
No Research Support Staff have been added
3.3 
Please add a Protocol Contact:
*
Name
Role
Training Record
Bennett, Dustin Lansing
Study Contact
 View Training Record
The Protocol Contact(s) will receive all important system notifications along with the Principal Investigator. (i.e. The 
protocol contact(s) are typically either the Protocol Coordinator or the Principal Investigator themselves). 
3.4
If applicable, please select the Designated Site Approval(s):
Name
Role
Training Record
No Designated Department Approval have been added
Add the name of the individual authorized to approve and sign off on this protocol from your Site (e.g. the Site Chair).
4.0
 
Project Information
4.1  
What department(s) will be associated with this protocol?
* 
Orthopedics
4.2  
Is the IRB of record for this study an IRB/HRPP that does NOT use EIRB? If Yes, complete the 
* 
application according to the IRB/HRPP Determination.
If your Projects or Protocols are under the oversight of another IRB that does use EIRB, stop this 
submission and contact the core site and request an invitation as a performing site.
If your Project or Protocol is now being submitted for the first time to an IRB that does use EIRB, 
continue with this application and answer the questions to be reviewed by the IRB.
Answering yes means the board of record is an IRB that does NOT use EIRB.
  Yes  
  No
4.3  
Is this protocol research, expanded access, or humanitarian use device?
* 
 Yes  
 No

4.4  
 What type of protocol is this?
*
Behavioral Research
Biomedical Research
Clinical trial (FDA regulated)
Educational Research
Expanded Access
Humanitarian Use Device (HUD)
Psychosocial Research
Oral History
Other
4.5  Are you conducting this project in pursuit of a personal degree?
 Yes  
 No
4.7  
Is this human subjects research? (As defined by 32 CFR 219) 
* 
   Human subject means a living 
individual about whom an investigator (whether professional or student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, and 
uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes  
 No
4.8  
 Do you believe this human subjects research is exempt from IRB review?
*
  Yes  
  No
5.0
 
Personnel Details
5.1  Does the Principal Investigator have a Permanent Change of Station (PCS) Date or Estimated 
Institutional Departure Date (EIDD)?
  Yes  
  No
5.2  List any Research Team members without EIRB access that are not previously entered in the protocol:
No results found
5.3  Are any Contractors or Subcontractors involved in this study? If yes, please list them and describe their role.
  Yes  
  No
No results found
5.4  
Will you have a Research Monitor for this study?

Yes 
No 
N/A 
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes  
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
No results found
Total amount of funding:
0
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes  
  No
All personnel engaged in research must complete and attach a Conflict of Interest (COI) form.
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
  Yes  
  No
8.2  Study Facilities and Locations:
Institution
Site Name
Site Role
FWA or DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
No results found
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing for 
Site
No results found

8.3  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local 
research context has been considered
  Yes  
  No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes  
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to 
study approval)
  Yes  
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
Trigger point injections AND pain
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the 
protocol.  The background section should clearly support the choice of study variables and 
explain the basis for the research questions and/or study hypotheses.  This section establishes 
the relevance of the study and explains the applicability of its findings
Opioid addiction and abuse have become a significant burden on the healthcare 
system since this class of medication was first used in the 1990s. Opioid 
medication’s highly addicting properties have led to its classification as an 
epidemic by the CDC in 2011. Alternative means of pain control for highly 
invasive procedures need to be explored. Orthopedic surgery specifically 
accounts for an estimated 8.8% of iatrogenic opioid use disorder (Trasolini et al. 
2018). More effort should be directed to explore non-opioid interventions in the 
post-operative setting of orthopedic surgery to reduce the use of opioids and risk 
of addiction.
                In an orthopedic setting one of the most preformed surgeries is the total 
knee arthroplasty (TKA). This procedure is most commonly performed in cases of 
severe osteoarthritis; some other indications include rheumatoid arthritis, 
deformity, and trauma. There are several surgical techniques to achieve this 
operation; however, all include performing an arthrotomy which is creating a semi-
permanent opening by dissecting the superficial soft tissue to expose the bony 
anatomy of the knee joint. Those bony structures include the distal aspect of the 
femur, the patella, and the superior aspect of the tibia. By performing the 
arthrotomy the surrounding muscles and fascia are manipulated and temporarily 
displaced leading to stiffness, trigger points, and pain. This constellation of 
symptoms makes up a condition called myofascial pain syndrome. Treatment of m

yofascial pain syndrome with use of trigger point injections has shown that 
inactivation of myofascial pain trigger points around the knee joint can promote 
structural remodeling of the surrounding skeletal muscle to regulate the 
biomechanical balance, thus improving the clinical symptoms of knee 
osteoarthritis (Lin et al, 2022).
There have been limited studies aimed at the treatment of myofascial pain 
syndrome in the acute setting of a TKA. Mayoral et al. (2013) conducted a 
randomized double-blinded, placebo-controlled clinical trial where patients who 
underwent a TKA had dry needling completed in the pre-operative and intra-
operative setting. This study demonstrated an improvement in pain scores within 
the first month of surgery in the dry needling group compared to a sham group. 
This has been the only study to date to address direct intervention for myofascial 
pain syndrome around the operative time frame. Henry et al. (2012) conducted a 
prospective study in which patients on the waitlist for a TKA were treated with 
trigger point injections; patients reported an improvement in pain up until the TKA 
procedure could be completed. Although Henry et al. did not assess pain in the 
post-operative setting, this study nonetheless demonstrated that myofascial pain 
syndrome is a component of osteoarthritis.
Despite these favorable results there are no studies that look at trigger point 
injections in the post-surgical setting. The aim of this study is to perform trigger 
point injections with administration of a local anesthetic immediately following 
TKA to assess the effect on pain scores. The trigger point injection/experimental 
group will be compared to a sham injections/control group where a superficial 
injection will be made into the dermis and no anesthetic will be injected. Injections 
will include two injections to four muscle bellies: the vastus medialis, vastus 
lateralis, medial, and lateral gastrocnemius muscle belly. Injections will include 
0.5 mL of lidocaine without epinephrine and will be outside of the operative area 
distal and proximal to the joint, the popliteal fossa and incision site. With each 
injection the plunger will be pulled back to ensure placement of the needle is 
outside vascular structures. To assess the primary outcome measures, patients 
will complete a Visual Analogue Scale (VAS) which ranges from 0 (no pain) to 
100 (severe intolerable pain) on post operative day (POD) 1 and at follow-up visits
during weeks 2 and 6.  The secondary outcome will assess how much opioid 
medication (ie, MME) was used in the immediate post-operative period through 
the week 6 follow-up visit.
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
The aim is of this study is to explore the effect of a pain intervention (ie, trigger 
point injection) vs. a sham injection on managing post-surgical pain and reducing 
the reliance on systemic opioid analgesics. Outcomes include the VAS on POD1 
and week 2 and week 6 follow-up appointments. Opioid use will also be 
evaluated during these intervals.
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, 
cohort, etc.). Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug 
research

Prospective, interventional study comparing trigger point injections vs. sham 
injections on VAS pain scale ratings and opioid use.
9.5  Target Population:
Describe the population to whom the study findings will be generalized
DoD beneficiaries aged 45 years and older who will be receiving a TKA, on either knee.
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
The purpose of this study is to explore a unique pain management modality to reduce the use of 
opioids following a routine surgery in the military hospital setting. This will benefit the 
Department of Defense by improving post surgical pain, decreasing overall opioid use which in 
turn may lead to decrease rate of opioid use disorders, shorter inpatient stays and decrease 
adverse medication side effects. 
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
Step 1: A HIPAA Waiver will be used to access MHS Genesis to obtain all joint 
surgeons’ case lists for those patients scheduled for surgery, all those not 
scheduled for a TKA will be removed from the list. The principal investigator will 
review case lists to identify name, TKA procedure, date scheduled for TKA, and 
phone. Patients scheduled for a TKA will be contacted within two weeks of their 
surgery to discuss the study.  Study inclusion and exclusion criteria will be 
reviewed with patients who are interested in participation to ensure they are 
eligible. Those who are eligible will be scheduled for an appointment with the 
 
principal investigator before TKA surgery, ideally at their pre-op visit (standard of 
care visit) but may occur on the day of their surgery, to review consent 
documents and answer any questions. In order to ensure patient understanding, 
a copy of the consent documents will be emailed (if email address is provided) to 
the patient prior to the appointment to allow him/her to review the consent in 
advance. 
Step 2: Patients return for their appointment to review and sign the consent 
documents either at their pre-operative visit or day of surgery.  Consents will be 
sign either during their pre-operative appointment in a clinic exam room or during 
the day of their surgery in the PACU. Consenting a patient in the PACU on the 
day of surgery is a last resort and all efforts will be made to complete consents 
during pre-operative clinic visit. During the consent phase the PI and/or AI will not 
be in military uniform and will not have their rank displayed. After consent 
documents are signed, participants are assigned to a study group. Due to 
academic time constraints (i.e. deadlines to complete and present the research), 
an alternating convenience sample approach will be taken for study group 
assignment. Each participant will be assigned a subject ID number based on their 
order of enrollment (e.g., the first participant enrolled will be assigned 1, second 
participant enrolled assigned 2, and so on). Every participant with an odd number 
will be placed in the trigger point injection group (experimental) and those 
assigned an even number will be placed in the sham injection group (control). 
Those in the trigger point injection group will have an E after the number and 

those in the sham injection group an S. The study participants will not know 
which study group they will be assigned to.  An equal number of participants will 
be included in each group (ie, trigger point injection vs. sham injection). 
Step 3a: (Trigger point injection group) The principal investigator will identify 
 
relevant structures to include the vastus medialis, vastus lateralis, medial, and 
lateral gastrocnemius muscle bellies by utilizing anatomical landmarks. Once 
those structures are identified, each area will be prepped in an aseptic fashion 
with alcohol swabs. Two injections will be made in each muscle belly. Each 
injection will include 0.5 mL of 1% lidocaine without epinephrine. A total of eight 
injections will be administered with a total of 4 mLs of 1% lidocaine without 
epinephrine using a 1 ½” 25-gauge needle. A separate needle and syringe will be 
utilized for each of the four muscle bellies. Careful consideration to avoid 
neurovascular structures will be taken by retracting the plunger to ensure needle 
placement is outside vascular structures with each injection. A blind will be placed 
between the patient and the needle in order for the patient not to witness the 
injection, which is the same protocol as the sham injection. The blind used will be 
a drape or other soft item held by a person not involved with the study to obscure 
the vision of the subject during the injection and allow the investigator to use both 
hands to safely conduct the injection and aspiration procedure. The local 
anesthetic will be massaged into the area to ensure the medication disperses 
thoroughly into the muscle belly. After the needle is removed, the area will be 
cleaned with alcohol swabs and a bandage will be applied. This will be completed 
on POD 0 (ie, the day of the TKA procedure). Within the informed consent the 
consenting verbiage will ensure that the participants will not be able to identify 
injection technique that will identify whether they are in the sham or experimental 
group.   
Step 3b: (Sham injection group) The principal investigator will identify relevant 
structures to include the vastus medialis, vastus lateralis, medial and lateral 
gastrocnemius muscle. Once those structures are identified using anatomical 
landmarks, each area will be prepped in an aseptic fashion with alcohol swabs. A 
needle with a syringe filled with sterile water will be inserted into the epidermis to 
mimic an actual trigger point injection. The needle will be left in place for 3-5 
seconds to create the false perception of injection anesthetic into the muscle 
groups. No sterile water will be injected into the participant. Since the effects from 
the anesthetic block will still be active and the injections will be administered in a 
position that prevents the participant from viewing the procedure, participants will 
not know that there is nothing being injected into the area. This will occur by 
placing a blind between the patient and the needle in order for the participant not 
to see that no water will be injected. The blind used will be a drape or other soft 
item held by a person not involved with the study to obscure the vision of the 
subject during the sham injection and allow the investigator to use both hands to 
 the needle is removed the 
safely conduct the sham injection procedure.  After
area will be cleaned with alcohol swabs and a bandage will be applied. Four 
separate needles and syringes will be utilized for each location. This will be 
completed on POD 0 (ie the day of the TKA procedure). Within the informed 
consent the consenting verbiage will ensure that the participants will not be able 
to identify injection technique that will identify whether they are in the sham or 
experimental group.   
Step 4: On POD0 (after TKA surgery, the investigator will review MHS Genesis to 
 
obtain demographic information (age, sex, beneficiary status, BMI), morphine 
milligrams equivalents (MME) using the Medication Administration Record (MAR) 
Summary, prior pain medication history, diabetic history, tobacco use, anesthetic 
block type, surgical site, ICD codes, complications, and discharge disposition.
Step 5: On POD1, participants in each study group will be provided with the VAS 
and Opioid Use questionnaires.  The VAS pain scale questionnaire will be used 
to report average pain scores by placing a hash mark (/) on the numbered scale 

on the region that best represents their pain and writing the number (a whole 
number) on the form; scores range from 0 (no pain) to 100 (severe intolerable 
pain). The Opioid Use questionnaire will be used to document average opioid use 
following discharge.  Both questionnaires will be completed by all participants at 
POD1, week 2 and week 6 visits. The VAS will be given to the participant with the 
intake form that is provided by the orthopedic technician, and the investigator will 
provide the Opioid Use questionnaire to the participant during the visit, and 
review the MAR Summary to obtain and calculate the total MME from POD0 to 
POD1 using MDCalc . Prior to ending the visit, the investigator will ask 
participants to bring in their opioids to be physically counted at their week 2 and 
week 6 visits.
Step 6: The investigator will provide a reminder phone call 1-2 days prior to the 
week 2 and week 6 appointments to ensure participants remember to bring in 
their medication.
Step 7: Participants return for the week 2 and week 6 visits. They are given VAS 
and Opioid Use questionnaires to complete, and opioid medication is counted. On
ce opioids have been accounted for, MME will be calculated.
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the 
data will be operationally measured.
Injection type: Dichotomous variable. Trigger point or sham injection.
Visual analogue scale:  Discrete variable. Will be scaled from 0 (no pain) to 100 
(severe intolerable pain) and will be measured at POD1, week 2, and week 6. 
The VAS will be presented to the participant on paper.
Morphine milligram equivalent (MME): Discrete variable. Will be measured 
from POD 0 to POD1, then a total MME will be calculated from POD1 to week 2 
and week 2 to week 6. This will be calculated utilizing the MME calculator on 
MDCalc.
Block: Categorical variable. Spinal, adductor or femoral nerve block determined 
by anesthesiology.
Age: Continuous variable. Age stated in years at time of surgery as stated in 
EHR.
Prior Pain Medications: Categorical variable. Obtained from EHR.
Discharge disposition: Dichotomous variable. Discharge to skilled nursing 
facility or home, discharge disposition will be reviewed in the discharge summary.
Active Duty, Dependent, Retiree: Categorical Variable.
Sex: Categorical (male, female). Obtained from EHR.
BMI: Categorical variable. Obtained from EHR. Categories will be BMI of 24.9 or 
less, BMI 25-29.9, and BMI greater than or equal to 30.
Nicotine use: Dichotomous variable. Obtained from EHR. Current use at time of 
injury.
History of Diabetes: Dichotomous variable. Obtained from EHR.
ICD Code: Categorical Variable. Obtained from EHR.

Laterality: Categorical Variable. Left or Right TKA
Complications: Categorical Variable. Pulmonary embolism/deep vein 
thrombosis, surgical site infection, severe pain from the injections, other, and 
multiple for more than one complication.
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
  Yes  
  No
11.0
 
Statistical/Data Analysis Plan
11.1  Data Analysis Plan and Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific 
aims, and/or research hypotheses. Explain how missing data and outliers will be handled in the 
analysis. The analysis plan should be consistent with the study objectives. Include any subgroup 
analyses (e.g., gender or age group). Specify statistical methods and variables for each analysis. 
Describe how confounding variables will be controlled in the data analysis.
Demographic (age at time of surgery, BMI, sex, active duty/dependent/retiree 
status), medical (ICD code, nicotine use, history of diabetes, prior pain 
medications), laterality of the TKA (left or right), discharge disposition, and 
anesthetic block type (spinal, adductor, or femoral nerve block) data will be 
summarized overall and as a function of injection group using descriptive 
statistics (eg, mean, standard deviation, median, minimum, maximum, frequency, 
percentages) and 95% confidence intervals to describe the sample. Appropriate 
inferential statistics (eg, independent samples t tests, chi square tests) will be 
performed to determine if there are statistically significant differences in any of 
these variables between the two injection groups. If so, multivariable techniques 
(eg, ANOVA or regression) including these potentially confounding variables in 
the analyses and/or stratification will be undertaken.
VAS pain scores and the dosage (MME) of opioids will be evaluated in patients 
as a function of injection type (ie, trigger point injection vs. sham injection) at 
each time point. Data will be assessed for normality and homogeneity of variance 
to determine whether parametric (eg, independent samples t tests, repeated 
measures ANOVAs) or nonparametric (eg, Wilcoxon Mann Whitney tests, 
Skillings-Mack tests) methods are appropriate.
In addition, the number of patients with a VAS>40 (indicating a “significant” level 
of pain) will be calculated and compared in each group and at each time point 
using the chi-square test (or the Fisher’s Exact test if assumption regarding 
minimum expected cell counts is not met) as well as McNemar’s tests. 
 The critical alpha level will be set at .05. Missing data will be handled using the 
“pairwise deletion” method; this method still includes patients with some missing 
data in the analyses when possible.
The plan is to use 10-15 participants per group, although if time and resources 
permit, we will include more patients to increase the power of the study and 

account for possible dropouts up to a maximum of 50 patients per group. 
Recruitment and enrollment will end once the target sample size has been 
achieved.
11.2  Sample Size:
The plan is to use 10-15 participants per group, although if time and resources permit, we will 
include more patients to increase the power of the study and account for possible dropouts up to 
a maximum of 50 patients per group (maximum of 100 patients total).
11.3  Total number of subjects requested (including records and specimens):
100
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
Experimental (ie, trigger point injection) group will include 10-15 patients (up to a maximum of 
50 patients) and placebo (ie, sham injection) group will include 10-15 patients (up to a 
maximum of 50 patients). Recruitment and enrollment will end on 31 December 2025.
11.5  Please provide a justification for your sample size
We used G*Power 3.1 (Dusseldorf Germany) to perform sample size calculations 
for our study. We designed these calculations using the primary outcome 
measure (ie, VAS pain scale rating in each injection group) which will be 
statistically compared using the independent samples t test or its nonparametric 
equivalent (ie, the Wilcoxon Mann Whitney test) if the assumptions for the 
independent samples t test (ie, normality and homogeneity of variance) are not 
met. 
Using the more conservative Wilcoxon Mann Whitney test (Type 1 error/alpha 
level=.05 (two tailed) and power=.80), a sample size of 30 (ie, 15 in the trigger 
point group and 15 in the sham group) would allow us to detect a statistically 
significant difference in VAS pain scale ratings if a “large” effect size of 1.1 was 
obtained. A “large” effect size of 1.1 corresponds to an average difference (delta) 
in VAS scores between groups of  >=28 units and an average standard deviation 
in each group of   <= 25 units. This standard deviation is similar to Mayoral et al. 
(2013) who reported an average standard deviation of 25 units for the VAS at the 
1 month follow up. Note that Mayoral et al. (2013) did not report VAS scores on 
POD1, although their average difference (delta) in VAS scores at 1 month was 
smaller than 28 units.
If up to 5 patients (eg, 30%) per group drop out of the study, a lower sample size 
of 20 (ie, 10 in the trigger point group and 10 in the sham group) would allow us 
to detect a statistically significant difference in VAS pain scale ratings if a larger 
effect size of 1.4 was obtained. This “larger” 1.4 effect size corresponds to an 
average difference (delta) in VAS scores between groups of >=35 units and an 
average standard deviation in each group was <= 25 units (again using the more 
conservative Wilcoxon Mann Whitney test (Type 1 error/alpha level=.05 (two 
tailed) and power=.80)).
In summary, our aim of including at least 10-15 patients per group would allow us 
to statistically detect a “large” effect of trigger point injections (relative to sham 
injections) on VAS pain ratings assuming our standard deviations were <= to the 
standard deviations in VAS pain scales reported by Mayoral et al. (2013). In 
addition, if statistically significant differences are not found, the data from our 

study can be used to perform sample size calculations to power future larger 
studies that could potentially detect smaller effects. Our data can also be used for 
potential future meta-analyses (ie, the statistical combination of the results of 
multiple studies addressing a similar research question).
Addendum:
Sample sizes for other combinations of the standard deviation and difference in 
means (Delta) are
shown in the table below for illustrative purposes only. The “effect sizes” for these 
combinations are derived using Cohen’s D (Cohen, 1988). A larger sample size is 
necessary to detect a smaller “true effect.”
Delta    SD        n          Cohen_D        Effect_Size
20        18.5     15         1.08                 large
25        18.5     10         1.35                 large
12.0
 
Participant Information
12.1  Subject Population:
DoD beneficiaries aged 45 years and older who will be receiving a TKA, on either 
knee.
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does 
not match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel

Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Aged 45 years or older 
Planned to undergo primary total knee arthroplasty
Able to speak, read, and understand English
Willing to complete a study questionnaires
Willing to bring in their medications to be counted
DoD beneficiaries
No allergy to lidocaine 
Not fearful of needles
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Chronic opioid users (daily use of prescribed opioids for at least 90 days) 
Diagnosed with Fibromyalgia
Non-English speaking
Unable to read English
Unable to understand English
Pregnant
Allergy to lidocaine/sulfite allergy
Not willing to complete study questionnaires
Not willing to bring in their medications to be counted
Not a DoD beneficiary
Fearful of needles
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
A HIPAA Waiver will be used to access MHS Genesis to obtain all joint surgeons 
case lists for those patients scheduled for TKA. The principal investigator will 
review case lists to identify name, type of surgical procedure (i.e., TKA), date 

scheduled for surgical procedure, and phone. Patients scheduled for a TKA within 
two weeks will be contacted to discuss the study. Study inclusion and exclusion 
criteria will be reviewed with patients who are interested in participation to ensure 
they are eligible. Those who are eligible will be scheduled an appointment with 
 
the principal investigator before TKA surgery, ideally at their pre-op visit (consent 
will not on the same day as the surgery), to review consent documents and 
answer any questions. A copy of the consent documents may be emailed (if email 
address is provided) to the patient prior to the appointment to allow him/her to 
review them in advance.
13.2  Compensation for Participation:
No
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
No
13.4  Consent Process:   Revised Common Rule, Section 219.116:  General requirements for informed 
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in 
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad 
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and 
(c) of this section only with respect to the storage, maintenance, and secondary research uses of 
identifiable private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes  
  No
Please explain the consent process:
Patients will be recruited through use of a HIPAA Waiver to access joint surgeon 
case lists. Patients scheduled for a TKA will be contacted by the principal 
investigator and informed of the study. Those who desire to participate will have 
study inclusion/exclusion criteria reviewed to determine eligibility. Those eligible 
will be scheduled a consent appointment. The investigator will offer to email (or 
provide by hard copy) consent document to review prior to the appointment. 
When patients returns for consenting, they will be taken to a private room (clinic 
exam room or private room in the PACU) to conduct the consent procedures. 
Consent documents will be reviewed with patients and any questions asked with 
be answered. Patients who desire to enroll in the study will sign the consent 
documents. The investigator will sign the consent documents, then provide a 
copy to the patient. During the recruitment and consenting phase, the PI or AI will 
not be in military uniform or have their rank visible.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the 
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from 
the study

At any point in the study participants can self-withdrawal from the study if they 
have a poor response to the injections, are unable to tolerate all injections, not 
willing to complete questionnaires, intraoperative complications (pulmonary 
embolism, deep vein thrombosis, surgical site infection, multiple or other), not 
willing to bring in their medications or if they choose to no longer participate in the 
study.  However, any data collected prior to withdrawal will still be analyzed.
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach 
of confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do 
not describe risks from standard care procedures; only describe risks from procedures done for 
research purposes
Risk of breach of confidentiality. Other risks of harm include allergy to the 
medication used in the trigger point injection, pain, bleeding, injury to 
neurovascular structures, and infection. Being selected for the sham can 
potentially increase a patient’s risk for pain.
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate 
risk of harms to subjects and study personnel
Risk is limited by coding the data, security limiting access of the data set to 
investigators, password protected files, and lock and key.
Injections will be performed by a trained provider under an aseptic technique by 
prepping the site with alcohol swabs. All injection sites will be marked utilizing 
landmarks to identify each muscle belly. The plunger will be retracted prior to 
injecting medication to ensure needle placement is not within a vascular 
structure. One needle and plunger will be used for each muscle belly to limit risk 
of infection. After completion of all injections the injection site will be cleaned with 
alcohol swabs and a bandage will be applied. 
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and 
records throughout the study and at its conclusion (e.g., destruction, long term storage, or 
banking). Explain the plan for securing the data (e.g., use of passwords, encryption, secure 
servers, firewalls, and other appropriate methods). If data will be shared electronically with 
other team members/collaborators outside the institution, describe the method of transmission 
and safeguards to maintain confidentiality. Explain whether this study may collect information 
that State or Federal law requires to be reported to other officials or ethically requires action, e.
g., child or spouse abuse

Risk is limited by coding of the data set, password protection, locked cabinet
 
/drawer, and security limiting access of the data set to investigators.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits 
to a specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and 
they cannot provide their own consent, the protocol must describe the intent to directly benefit 
all subjects
The potential benefits of this study include a decrease in pain levels following 
TKA. This could result in decreased risk for opioid use disorder. Also, this may 
secondarily improve recovery and allow for easier participation in physical 
therapy.   
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and 
all research activities, etc.
All consents and other information will be stored on a CAC enable computer that 
is password protected only accessible to investigators. All consents will be 
performed by either the PI and/or AI without official military uniforms or ranks 
displayed in a private exam or PACU room. Hard copy consent documents will be 
stored in a locked drawer, separate from other study documents, and saved for at 
least six years after study closure. After this period, the hard copy, and electronic 
study documents will be destroyed by shredding and/or files deleted. 
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject 
could possibly benefit medically or otherwise from the information, state whether or not the 
results of screening, research participation, research tests, etc., will be shared with subjects or 
their primary care provider. State whether the researcher is obligated or mandated to report 
results to appropriate military or civilian authorities and explain the potential impact on the 
subject
If any incidental unexpected findings are identified by the investigators during the 
medical record review (i.e., capturing medical or surgical history data), he/she will 
inform the participant and his/her primary care provider to facilitate follow-up. 
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 

Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form 
are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse 
events will be for this study, describe the likelihood (frequency, severity, reversibility, short-
term management and any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or 
consent form are needed and the scale that will be used to grade the severity of the adverse 
event
Pain – pain is anticipated given the type of intervention. However, pain is 
temporary and will improve after the local anesthetic takes effect. 
Bleeding – another rare complication of trigger points. If a vascular structure is 
infiltrated the injection will be halted. Once the needle is removed will apply direct 
pressure for 3-5 minutes to ensure no continued bleeding.  Likelihood of 
accessing vascular structures is minimal due to the location of arteries as they 
relate to musculature aimed at injecting.  
Infection – very low risk for infection following trigger point injection, <0.05% of 
adverse side effects are reported. If infection takes place, then the patient will be 
treated with antibiotics. If infection includes an abscess will treat with incision and 
drainage.
Adverse events such as infection, damage to vascular structures that cause 
hematoma and excessive bleeding, injection of lidocaine into the blood stream 
are identified will be reported to the IRB. These adverse events will be monitored 
for during each visit through visually inspecting the injection sites and completing 
a neurovascular evaluation. The patient may also verbally inform the principal 
investigator of any of these potential adverse effects. The IRB will be notified by 
completing and submitting an eIRB Reportable Event Form (serious adverse 
event, unanticipated problem) or reporting at the time of continuing review (all 
others). The form will be routed to the DGMC C&T Board. The DGMC HRPP staff 
regularly monitor C&T Board notifications; they will notify the institution’s HRPO 
of the reportable event by email, telephone, or in-person until it has been 
received and acknowledged.   If any adverse event takes place the design of this 
study will be examined and determine is research protocol needs to be revised.
17.0
 
Equipment/non-FDA Regulated Devices

17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes  
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.2  Drugs, Dietary Supplements and Biologics/Vaccines details:
Are drug(s) in this research being used in accordance to the approved labeling?
Are drug(s) in this research being used in a manner other than its approved labeling?
Enter Dietary Supplements and Biologics/Vaccines in the Drug Information table. Complete all 
relevant fields in the table (“Protocol Drug Details” screen). If the question is not relevant, leave 
the question blank and/or do not change the default selection.
View 
Details
Drug Name
FDA Approved
A new drug or a 
new use of an 
already 
approved drug:
IND Number
Trade Drug 
Name:
lidocaine 1-
2% with or 
without 
epinephrine
Generic Drug 
Name:
Investigational 
Drug Name:
Yes 
No 
 
Trade Drug Name:
lidocaine 1-2% with or without epinephrine 
Generic Drug Name:
 
Investigational Drug Name:
 
Identify the name of the 
manufacturer or source of 
investigational drug/biologic:
Hospira  
Is the drug supplied at no cost?
Yes  
Is the Drug FDA Approved:
Yes  
Is this a new drug or a new 
use of an already approved 
drug
No  
Is an IND necessary
No  
IND Number
 
Who holds the IND:
N/A  
IND details:
 
If FDA Approved and an IND is 

not required, Please provide a 
rationale for exemption:
 
Are you currently using this 
IND in another research 
project?
No  
If yes, list the IRB Number(s):
 
Dose Range:
4mL  
Frequency:
once  
Route of administration:
intramuscular  
Will the investigational 
pharmacy be dispensing?
Yes  
If the source is not a FDA 
licensed facility, provide details 
regarding the purity, quality, 
stability and sterility of the 
investigational drug/biologic:
 
Identify who will be preparing 
the investigational drug
/biologic for administration and 
describe in detail how it will be 
prepared:
The PI will remove the lidocaine 1% without epinephrine 
from the pyxis within the orthopedics clinic. Once the 
medical is removed the PI will wear gloves and prepare 4 
25-gauge needles and 4 5 mL syringes. Once all needles 
are attached to the syringes the cover to the lidocaine will 
be removed and cleaned with alcohol swabs before each 
draw. Once 1 mL of lidocaine 1% without epinephrine is 
prepared in each syringe the needles will be recapped and 
immediately go to the patient's room for injection.  
Indication(s) under 
Investigation:
 
Where will the drug be stored
Orthopedic clinic pyxis  
Drug Storage Restrictions 
(including temperature, etc.):
Medication will be stored in the clinic pyxis at room 
temperature  
Administration Instructions:
Prior to injection the PI will identify those anatomic 
landmarks meant for injection. Then the areas will be 
marked by indenting the skin with an empty pen, there will 
not be any ink on the injection site. The area will be 
prepped with chlorohexidine. Once the site is prepped the 
investigator will make two injections into the muscle belly 
and injection 0.5mL of lidocaine 1% without epinephrine. 
Once the needle is removed it will be discarded in the 
appropriate sharp's container. The area will then be cleaned 
with alcohol swabs and a band aid applied. These steps will 
be repeated for all 4-injection sites.  
Possible Untoward Effects, 
Their Symptoms & Treatment:
 
Potential or Actual Antidotes 
for Excessive or Adverse Drug 
Effect:
 
Contraindications and 
Interactions, If Known:
Allergy to medication  
Investigators Authorized to 
Prescribe:
PI and AI are authorized to prescribe lidocaine 1% without 
epinephrine  
18.4  Reporting Requirements for FDA-regulated research under IND and IDE:
Describe the process for complying with FDA regulatory requirements for adverse event 
reporting and adverse device effects reporting to the sponsor
N/A

1.  
2.  
3.  
4.  
5.  
6.  
7.  
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
References and Glossary
20.1  References:
Lin, X., Li, F., Lu, H., Zhu, M., & Peng, T. Z. (2022). Acupuncturing of myofascial pain 
trigger points for the treatment of knee osteoarthritis: A systematic review and meta-
analysis. Medicine, 101(8), e28838. https://doi.org/10.1097/MD.0000000000028838
Mayoral, O., Salvat, I., Martín, M. T., Martín, S., Santiago, J., Cotarelo, J., & Rodríguez, 
C. (2013). Efficacy of Myofascial Trigger Point Dry Needling in the Prevention of Pain after 
Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Trial. 
Evidence-Based Complementary and Alternative Medicine, 2013, 1–8. https://doi.org
/10.1155/2013/694941
“The Opioid Epidemic in the United States.” SHADAC. Last modified May 15, 2024. 
Accessed July 21, 2024. 
. 
https://www.shadac.org/opioid-epidemic-united-states
Trasolini, Nicholas A., Braden M. McKnight, and Lawrence D. Dorr. “The Opioid Crisis and 
the Orthopedic Surgeon.” The Journal of Arthroplasty 33, no. 11 (November 2018). 
Ma, Yan-Tao, et al. “Dry Needling on Latent and Active Myofascial Trigger Points versus 
Oral Diclofenac in Patients with Knee Osteoarthritis: A Randomized Controlled Trial.” BMC 
Musculoskeletal Disorders, vol. 24, no. 1, Jan. 2023, p. 36. DOI.org (Crossref), https://d
.
oi.org/10.1186/s12891-022-06116-9
R Core Team (2022). R: A language and environment for statistical computing. R 
Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.
org/.
Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). 
Hillsdale,NJ: Lawrence Erlbaum. R Core Team (2022). R: A language and environment for 
statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://
www.R-project.org/.
20.2  Abbreviations and Acronyms:
mL – milliliter 

PACU – Post-anesthesia Care Unit
POD – post-operative day
TKA – Total knee arthroplasty