Double-blind, Prospective Comparison of Medications Used in Trigger Point Injections - Ketorolac, Lidocaine, or Dexamethasone
Phase: PHASE4
Conditions: Myofascial Pain
Sponsor: University of Utah

 
 
 
NCT: 03028012 
 
 
 
TITLE: Double-blind, prospective comparison of medications used in trigger point 
injections – ketorolac, lidocaine, or dexamethasone 
 
 
 
PRINCIPLE INVESTIGATOR: Daniel Cushman 
 
 
 
 
ORGANIZATION:  Physical Medicine & Rehabilitation  
University of Utah Orthopedic Center 
590 Wakara Way 
Salt Lake City, Utah 84108 
 
Report Date:  
June 18, 2020 
 
Type of Report: 
Clinical Trails Study Closure Protocol 4.5.2017 
 
 

Protocol Summary (ERICA) 
 
IRB_00098370 
Page 1 of 7 
 
IRB Approval 4/5/2017 
 
 
Double-blind, prospective comparison of medications 
used in trigger point injections – ketorolac, lidocaine, or 
dexamethasone 
 
Protocol Summary 
 
 
 
IRB Approval Date of Current Version: 4/5/2017 
University of Utah IRB #: IRB_00098370 
Sponsor:  
  
Principal Investigator: Daniel Cushman 
Internal Staff and  Sub-Investigators: 
Nathan Clements 
Tera Grant 
Masaru Teramoto 
Stuart Willick 
External Sub-Investigators: 
 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

Protocol Summary (ERICA) 
 
IRB_00098370 
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IRB Approval 4/5/2017 
 
Background and Introduction 
 
Background 
Trigger point injections (TPIs) are a commonly-performed procedures by physicians for the 
treatment of myofascial pain, specifically targeting myofascial trigger points 
(MTrPs).  Commonly injected substances include local anesthetic1-10, botulinum toxin11-19, or 
corticosteroid (CS)2,3,9,20,21, though non-steroidal anti-inflammatory drugs (NSAIDs)20,22-24 
and other substances25,26 have been reported. A Cochrane review27 found that intramuscular 
injection of local anesthetic demonstrated moderate evidence of benefit for mechanical neck 
disorders; no other treatment demonstrated greater benefit. 
Great variation is seen in how TPIs are performed, however.  The standard method was 
described by Simons and Travell28, and is often cited.  Hong et al.1 demonstrated that, similar 
to the technique described by Simons and Travell, obtaining a local twitch response (LTR) was 
the most important factor in producing pain relief.  Further research by Shah et al.29, which 
demonstrated an inflammatory component to MTrPs, also showed a decrease in inflammatory 
cytokines following trigger point injections that obtained a LTR.  Despite these findings, most 
studies do not use the LTR method in their TPI techniques.  
Prior studies2,3,9,20 demonstrated that most patients obtain significant relief from TPI, but did 
not identify differences between injection of CS or other substances.  However, none of these 
studies identified LTRs in their injection techniques.  
As can be learned from a review of the published literature on muscular trigger points, the 
cause of this condition is unknown, and no single treatment approach has been established as a 
clearly accepted gold standard treatment.  There is evidence, however, that there is an 
inflammatory component associated with trigger points and that obtaining a local twitch 
response is associated with a decrease in local inflammation at the site of a trigger point.  The 
combination of injecting an anti-inflammatory medication and obtaining a local twitch 
response has never been studied.  The purpose of this study is to examine the comparative 
effectiveness of injectable substances on patient outcome after a TPI with LTR identified, 
namely a CS (dexamethasone), a NSAID (ketorolac), or only a local anesthetic (lidocaine). 
 
 
 
Purpose and Objectives 
 
Hypothesis 
The main hypothesis of this study is that anti-inflammatory medications (ketorolac or 
dexamethasone) will provide longer-lasting and greater pain relief than just lidocaine in trigger 
point injections where a local twitch response is evoked at the time of the injection. 
Purpose/Specific Aims 

Protocol Summary (ERICA) 
 
IRB_00098370 
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IRB Approval 4/5/2017 
 
The primary objective of this study is to compare the efficacy of three substances used in TPIs 
with a LTR identified at the time of the injection:  a CS (dexamethasone), a NSAID 
(ketorolac), or only a local anesthetic (lidocaine). 
 
 
 
Study Population 
 
Age of Participants: 18-100 
 
Sample Size: 
At Utah: 
60  
All Centers: 
60 
 
Inclusion Criteria: 
1. Men or women age 18 or over 
2. At least one active trigger point, as defined by Simons and Travell 
 
 
Exclusion Criteria: 
1. Allergy or contraindication to any NSAID, CS, or local anesthetic 
2. Receiving anticoagulant medication 
3. History of bleeding disorder 
4. Pregnant or breast feeding women 
5. Gastrointestinal ulceration 
6. Pre-existing renal disease 
7. Pre-existing congestive heart failure 
8. Diabetes mellitus 
9. Prior myocardial infarction or stroke 
10. Fibromyalgia 
 
 
Design  
 
Observational Research 
Double Blind 
Randomized 
 

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Study Procedures 
 
Recruitment/Participant Identification Process: 
Subject recruitment 
Subjects will be recruited from the University of Utah Orthopaedic Center, Farmington Health 
Center, and South Jordan Health Center during an existing appointment.  Participation in this 
study will not require any additional study-specific visits.  Subjects requiring a TPI for 
treatment will be approached by a study team member who will provide a basic description of 
the study and review inclusion and exclusion criteria with the patient.  If the patient is 
interested in participating, a member of the study team will obtain written informed 
consent.  University of Utah physical therapists and physicians will be notified about this 
study and asked to help recruit appropriate subjects.  
  
  
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
University of Utah Orthopaedic Center, Farmington Health Center, and South Jordan Health 
Center 
 
Description of the consent process(es), including the timing of consent:  
Informed written consent will be obtained from all participants. The researcher will provide an 
explanation of the consent form and study details to these individuals. One of the investigators 
will always be available to speak with prospective participants that have questions. The 
potential participants can take as much time as they like until they choose to consent and do 
not have to consent on the same day the study is presented.  
 
Procedures: 
Consent process 
Consent: Written informed consent will be obtained from all participants. The researcher will 
provide an explanation of the consent form and study details to each participant. One of the 
investigators will always be available to speak with prospective participants that have 
questions. Institutional Review Board approval will be granted through the University of Utah. 
Study procedures 
TPIs are a standard procedure performed by physicians.  Regardless of participation in the 
research study, the procedure will be performed in the same manner.  Participants will undergo 
TPIs by the following method.  A 3mL syringe with any of the three medications listed below 
would be drawn by an assigned, unbiased, and unblinded health care professional (e.g. medical 

Protocol Summary (ERICA) 
 
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IRB Approval 4/5/2017 
 
assistant, nurse, etc.), leaving its contents unknown to the physician doing the injection.  A 
25g, 1.5” needle will be used for all injections.  The needle will be inserted into the trigger 
point with the goal of eliciting a LTR.  When a LTR is obtained, 0.1mL will be injected into 
that location within the muscle. This will be repeated until LTRs disappear, or 1.0mL has been 
injected, whichever comes first.  This can be performed in a similar manner for all affected 
muscles, up to a maximum of 2mL.  
Blinding: Both the physician performing the injection and the participant will be blinded to the 
medication injected.  Only the assigned health care professional will be unblinded.  Each 
substance is clear and cannot be distinguished from the other.  The blinding procedure has 
been fully discussed and approved by the medical staff at all sites (UUOC, FHC, SJHC).  
Study Drug Ordering:  A study team member (with IDS assistance), will create a blinded study 
drug order in the medical record (Epic).  This blinded study drug order will have a title similar 
to “study blinded ketorolac/dexamethasone/lidocaine injection, 2mL.” When a participant 
enrolls, the blinded PI will place an order for the study drug.  The assigned health care 
professional will access the participant’s medical record to ensure the PI has placed and signed 
an order for study drug.  
Randomization: A randomization schema will be created in Excel (with IDS assistance) by an 
unblinded study team member that will ensure even accrual numbers across the three different 
cohorts.  Neither the blinded physician, nor the participant will have access to this 
document.  A health care professional at each of the three participating sites will be unblinded 
and assigned to have access to this shared drive for purposes of randomizing newly enrolled 
participants and unblinding a participant in the event of an adverse reaction.  This 
randomization document will be kept and maintained on uBOX (a secure shared drive). Once 
the assigned health care professional has confirmed that an order has been placed and signed 
by the blinded PI for study drug, they will access the randomization schema to obtain a 
randomization number.  This randomization number will be either a 1, 2, or 3 and each 
number will correlate to a different study drug combination.  The health care professional will 
draw up the randomly assigned study drug outside of the participant’s room and hand-off the 
syringe to the PI for injection.  
Medical Record Documentation: After the medication has been administered, the blinded PI or 
the physician who completed the injection will document the process in the medical record, 
specifying how much of the 2mL study drug was used for the injection.  
Medication Inventory:  Each of the three participating sites will have the same medications for 
use and they will be stored in locked cabinets and labeled for investigational use only.  IDS 
will provide each site with a drug inventory log to document study drug usage.  This drug 
inventory log will be monitored by the Data and Safety Monitoring Board at intervals 
specified in this application.  
Unfortunately, the use of the local pharmacy (e.g. UUOC pharmacy or FHC pharmacy) will 
not be a feasible option.  This will take at least 30 minutes extra to obtain the medication, for 

Protocol Summary (ERICA) 
 
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which will be too time-intensive for most patients to tolerate.  Additionally, this will interrupt 
regular clinic flow to a large degree. 
All three medications used in this study have been shown to be safe, and are already used in a 
standard fashion for intramuscular injections; therefore, these medications will not pose undue 
risk to the participant. Furthermore, as lidocaine will be included in all injections, the 
participant will unlikely be able to differentiate which medication they received based off the 
presence or absence of short-term numbness. 
The PI has successfully administered these drugs in the below mentioned dosages and 
combinations.  From past experience, the PI does not express any safety concerns regarding 
the administration of these drug combinations. 
Subsequent injections 
Participants will be allowed to have subsequent injections, which is standard practice39-
43.  They may receive up to four injections, spaced at least 1 week apart.  The assigned health 
care professional will access the randomization schema at each subsequent visit to identify 
which substance was injected at their previous visit and use that same substance for all 
subsequent injections.  The primary time point will be maintained, and questionnaires will be 
administered.  
Medications: 
1. 1mL of 1% lidocaine + 1mL of 4mg/mL dexamethasone 
2. 1mL of 1% lidocaine + 1mL of 30mg/mL ketorolac 
3. 2mL of 1% lidocaine 
Outcomes: 
1. Pre- and post-injection numeric rating scale (NRS) from 0-10 with regards to the 
trigger point(s). 
2. Survey questions 
Primary outcome measure 
1. Responder (>50% NRS relief) 
Secondary outcome measures 
1. NRS improvement 
2. Brief pain inventory (BPI) improvement 
Time points: 

Protocol Summary (ERICA) 
 
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Participants will fill out a pre-injection survey that contains demographic information and 
pain- and function-related questions.  Participants will also complete a survey at the following 
time points: 
1. Immediately post-injection 
2. 1 week post-injection 
3. 2 weeks post-injection 
4. 4 weeks post-injection 
5. 3 months post-injection 
  
 
 
Procedures performed for research purposes only:  
TPIs are a standard procedure performed by physicians.  Regardless of participation in the
research study, the procedure will be performed in the same manner.  
The research component of this study is to compare the efficacy of three substances used i
TPIs with a LTR identified at the time of the injection:  a CS (dexamethasone), a NSAID 
(ketorolac), or only a local anesthetic (lidocaine). 
 
 
 
Statistical Methods, Data Analysis and Interpretation 
 
Statistical plan: 
Chi-square analysis will be used to identify differences in responders between 
groups.  Repeated-measures ANOVA testing will be used to identify changes in pain scores. 
Power Analysis: 
Similar to the study by Gerber et al.41, if 5% of patients spontaneously improve their MTrP 
status without intervention and aiming for detection of 10% responders, a sample size of 90 
subjects would be required.  However, in their study, they found that this was substantially 
overpowered due to a much higher percentage of responders.  We have identified a sample size 
of 60 subjects (20 per group) as being sufficient, based on the prior work being 
overpowered.  As they had a much larger response rate in their actual cohort, we feel that a 
conservative estimate of 15% responders would be appropriate (as opposed to 10%), which 
yields a sample size around 60 total subjects. 
 
 

 
 
 
NCT: 03028012 
 
 
 
TITLE: Double-blind, prospective comparison of medications used in trigger point 
injections – ketorolac, lidocaine, or dexamethasone 
 
 
 
PRINCIPLE INVESTIGATOR: Daniel Cushman 
 
 
 
 
ORGANIZATION:  Physical Medicine & Rehabilitation  
University of Utah Orthopedic Center 
590 Wakara Way 
Salt Lake City, Utah 84108 
 
Report Date:  
June 18, 2020 
 
Type of Report: 
Informed Consent Form 4-5-2017 
 
 

Dan Cushman, MD 
 
Page 1 of 5 
Double-blind, prospective comparison of medications used in trigger point injections – ketorolac, lidocaine, or dexamethasone  
FOOTER FOR IRB USE ONLY 
IRB Template Version: K1315 
 
 
University of Utah 
Institutional Review Board 
Approved 4/5/2017 
Expires 4/4/2019 11:59 PM 
IRB_00098370 
 
 
Consent and Authorization Document 
 
BACKGROUND  
Trigger point injections (TPIs) are a commonly-performed procedures by physicians for the treatment of 
myofascial pain.  Myofascial pain is a chronic pain disorder that presents in the form of pressure on 
sensitive points in muscles (trigger points).  This pressure results in pain in seemingly unrelated parts of 
the body and the discomfort generally persists or worsens with no treatment.  Commonly injected 
substances include local anesthetic, botulinum toxin (Botox), or corticosteroid (CS), though non-
steroidal anti-inflammatory drugs (NSAIDs), and other substances have been reported.   Prior studies 
have demonstrated that most patients obtain significant relief from TPI, but did not identify differences 
between injection of CS or other substances.   
 
No single treatment approach has been established as a clearly accepted gold standard treatment, and 
practitioners are quite variable in what they use for these injections.  There is evidence, however, that 
there is an inflammatory component associated with trigger points.  The combination of injecting an 
anti-inflammatory medication and obtaining a local twitch response has never been studied.  The 
purpose of this study is to examine the comparative effectiveness of injectable substances on patient 
outcome after a TPI, namely a CS (dexamethasone), a NSAID (ketorolac), or only a local anesthetic 
(lidocaine). 
 
STUDY PROCEDURES  
TPIs are a standard procedure performed by physicians.  Regardless of participation in the research 
study, the procedure will be performed in the same manner.  You will undergo TPIs by the following 
method.  A 3mL syringe with any of the three medications listed below would be drawn by an unbiased 
health care professional (e.g. medical assistant, nurse, etc.), leaving its contents unknown to the 
physician doing the injection and to you, the participant.  
 
Blinding: Both the physician performing the injection and you will be blinded to the medication injected.  
Each substance is clear and cannot be distinguished from the other.  The health care professional 
drawing up the medication will draw it up outside of the room.  The order will be signed by the blinded 
PI using a blinded study drug order.  .  All three medications used in this study have been shown to be 
safe, and are already used in a standard fashion for intramuscular injections; therefore, these 
medications will not pose undue risk to the participant. Furthermore, as lidocaine will be included in all 
injections, the participant will unlikely be able to differentiate which medication they received based off 
the presence or absence of short-term numbness. 
 
Randomization:  You will be randomly assigned to one of the three study medications listed below.   
 
Subsequent injections 
You will be allowed to have subsequent injections, which is standard practice.  You may receive up to 
four injections, spaced at least 1 week apart.  The health care professional will use the same substance 
the patient received on their previous injections.   
 

Dan Cushman, MD 
 
Page 2 of 5 
Double-blind, prospective comparison of medications used in trigger point injections – ketorolac, lidocaine, or dexamethasone  
FOOTER FOR IRB USE ONLY 
IRB Template Version: K1315 
 
 
University of Utah 
Institutional Review Board 
Approved 4/5/2017 
Expires 4/4/2019 11:59 PM 
IRB_00098370 
 
 
Medications: 
1. 
1mL of 1% lidocaine + 1mL of 4mg/mL dexamethasone 
2. 
1mL of 1% lidocaine + 1mL of 30mg/mL ketorolac 
3. 
2mL of 1% lidocaine 
 
Time points: 
You will fill out a pre-injection survey that contains demographic information and pain- and function-
related questions.  You will also complete a survey at the following time points: 
1. 
Immediately post-injection 
2. 
1 week post-injection 
3. 
2 weeks post-injection 
4. 
4 weeks post-injection 
5. 
3 months post-injection 
 
RISKS 
Common adverse effects from trigger point injections include soreness, hematoma, bruising, and 
medication allergy.  If you have an adverse effect, you will be instructed to call the Principal Investigator 
(PI).  If the PI deems this may be related to the medication, they will be unblinded for the purposes of 
proper medical triage.  For all intents and purposes, the participant will have received the standard 
treatment for their trigger point, but will be unaware of which medication they have received. 
 
UNFORESEEABLE RISKS 
In addition to the risks listed above, you may experience a previously unknown risk or side effect. 
 
BENEFITS 
TPIs are a standard procedure performed by physicians, so there are no added benefits to participation 
in this study, however the goal is to compare the efficacy of the three substances studied to possibly 
change standard of care for future patients.   
 
ALTERNATIVE PROCEDURES 
You may choose not to participate in this study and receive the standard of care trigger point injection 
your doctor and you decide on instead. 
 
PERSON TO CONTACT 
If you have questions, complaints, or concerns about this study, or feel you have been injured or become 
ill from being in this study, please contact Dr. Cushman or his research team at 801-581-5328 during 
regular business hours.  If this is after hours, please contact the hospital operator at 801-581-2121 and 
ask for the physical medicine & rehabilitation resident on call.  Let them know that you received a trigger 
point injection containing lidocaine and possibly dexamethasone or ketorolac.  
 
If you have inquiries regarding a serious (life-threatening) research-related injury, illness, or adverse 
effect, please seek immediate medical attention from your local hospital. 
 

Dan Cushman, MD 
 
Page 3 of 5 
Double-blind, prospective comparison of medications used in trigger point injections – ketorolac, lidocaine, or dexamethasone  
FOOTER FOR IRB USE ONLY 
IRB Template Version: K1315 
 
 
University of Utah 
Institutional Review Board 
Approved 4/5/2017 
Expires 4/4/2019 11:59 PM 
IRB_00098370 
 
 
Institutional Review Board: Contact the Institutional Review Board (IRB) if you have questions regarding 
your rights as a research participant. Also, contact the IRB if you have questions, complaints or concerns 
which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached 
by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu.   
 
Research Participant Advocate:  You may also contact the Research Participant Advocate (RPA) by 
phone at (801) 581-3803 or by email at participant.advocate@hsc.utah.edu.  
 
RESEARCH-RELATED INJURY 
If you are injured from being in the study, medical care is available to you at the University of Utah 
Hospital, as it is to all sick or injured people.  The University of Utah has not set aside any money to pay 
the costs for such care.  The University will work with you to address costs from injuries.  Costs would be 
charged to you or your insurance company (if you have insurance), to the extent those parties are 
responsible for paying for medical care you receive.  Since this is a research study, some health 
insurance plans may not pay for the costs.  By signing this consent form you are not giving up your right 
to pursue legal action against any parties involved with this research. 
 
The University of Utah is a part of the government.  If you are injured in this study, and want to sue the 
University or its doctors, nurses, students, or other people who work for the University, special laws may 
apply.  The Governmental Immunity Act of Utah is a law that controls when a person needs to bring a 
claim against the government, and limits the amount of money a person may recover.  See sections 63G-
7-101 to -904 of the Utah Code. 
 
VOLUNTARY PARTICIPATION 
Research studies include only people who choose to take part.  You can tell us that you do not want to 
be in this study.  You can start the study and then choose to stop the study later.  Your decision will not 
affect your relationship with the study team in any way. 
 
RIGHT OF INVESTIGATOR TO WITHDRAW PARTICIPANTS 
The investigator can withdraw you without your approval.  Possible reasons for withdrawal include if the 
investigator feels the study procedures place you at an unexpected risk. 
 
COSTS AND COMPENSATION TO PARTICIPANTS 
There are no additional costs to you for participating in this study.  The Trigger Point Injections would 
normally be done as standard treatment, so they will be billed to you or your insurance company. You 
will not be paid for participating in this study.   
 
NEW INFORMATION 
Sometimes during the course of a research project, new information becomes available about the drugs 
that are being studied. If this happens, your research doctor will tell you about it and discuss with you 
whether you want to continue in the study.   
 

Dan Cushman, MD 
 
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Double-blind, prospective comparison of medications used in trigger point injections – ketorolac, lidocaine, or dexamethasone  
FOOTER FOR IRB USE ONLY 
IRB Template Version: K1315 
 
 
University of Utah 
Institutional Review Board 
Approved 4/5/2017 
Expires 4/4/2019 11:59 PM 
IRB_00098370 
 
 
If you decide to withdraw at that time, your research doctor will make arrangements for your medical 
care to continue. If you decide to continue in the study, you may be asked to sign an updated consent 
form. Also, on receiving new information your research doctor might consider it to be in your best 
interests to withdraw you from the study. He/she will explain the reasons and arrange for your medical 
care to continue. 
 
NUMBER OF PARTICIPANTS 
We expect to enroll 90 participants at the University of Utah Orthopaedic Center, the Farmington Health 
Center, and the South Jordan Health Center.  
 
AUTHORIZATION FOR USE OF YOUR PROTECTED HEALTH INFORMATION  
Signing this document means you allow us, the researchers in this study, and others working with us to 
use some information about your health for this research study. 
 
This is the information we will use and include in our research records:  
- 
Demographic and identifying information like name, email address, date of birth  
- 
Related medical information about you like concurrent health issues, past procedures, 
medical history 
- 
All tests and procedures that will be done in the study 
How we will protect and share your information: 
• 
We will do everything we can to keep your information private but we cannot guarantee this. 
Study information will be kept in a secured manner and electronic records will be password 
protected. Study information may be stored with other information in your medical record. 
Other doctors, nurses, and third parties (like insurance companies) may be able to see this 
information as part of the regular treatment, payment, and health care operations of the 
hospital. We may also need to disclose information if required by law. 
 
• 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This website will not include information that can identify you.  At most, the 
website will include a summary of the results.  You can search this website at any time. 
 
• 
In order to conduct this study and make sure it is conducted as described in this form, the 
research records may be used and reviewed by others who are working with us on this research: 
o Members of the research team and University of Utah Health Sciences Center; 
o The University of Utah Institutional Review Board (IRB), which reviews research 
involving people to make sure the study protects your rights; 
 
• 
If we share your information with groups outside of University of Utah Health Sciences Center, 
we will not share your name or identifying information.  We will label your information with a 
code number, so they will not know your identity. 
 

Dan Cushman, MD 
 
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Double-blind, prospective comparison of medications used in trigger point injections – ketorolac, lidocaine, or dexamethasone  
FOOTER FOR IRB USE ONLY 
IRB Template Version: K1315 
 
 
University of Utah 
Institutional Review Board 
Approved 4/5/2017 
Expires 4/4/2019 11:59 PM 
IRB_00098370 
 
 
What if I decide to Not Participate after I sign the Consent and Authorization Form? 
You can tell us anytime that you do not want to be in this study and do not want us to use your health 
information.  You can also tell us in writing.  If you change your mind, we will not be able to collect new 
information about you, and you will be withdrawn from the research study. However, we can continue 
to use information we have already started to use in our research, as needed to maintain the integrity of 
the research.   
 
This authorization does not have an expiration date.   
 
 
CONSENT 
 
I confirm that I have read this consent and authorization document and have had the opportunity to ask 
questions. I will be given a signed copy of the consent and authorization form to keep. 
 
I agree to take part in this research study and authorize you to use and disclose health information 
about me for this study, as you have explained in this document. 
 
 
________________________ 
Participant’s Name 
 
________________________ 
 
 
 
 
____________ 
Participant’s Signature 
 
Date 
 
________________________ 
Name of Person Obtaining Authorization and Consent 
 
________________________ 
 
 
 
 
____________ 
Signature of Person Obtaining Authorization and Consent 
 
Date