Clinical trial NCT03704584
Conditions: Tenosynovitis
Keywords: orthopedic disorders corticosteroids(CS) Lidocaine Injections
Sponsor: Emory University
Start date: 2019-05-14; Completion date: 2020-01-14
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The clinical trial is a randomized control trial to compare the efficacy of a combined lidocaine and corticosteroid (CS) injection versus a corticosteroid injection (CS) alone on pain, range of motion, and patient reported outcomes for the treatment of common upper extremity tendinopathies and nerve entrapments that are often treated with a combination of these injectates.

Detailed description:
A tendon is a type of tissue that connects your muscles to your bones. These tissues help control actions such as running, jumping, grasping, and lifting. Without tendons it would be difficult to control the movement of your body. A protective layer known as synovium covers tendons. This sheath produces fluid, which keeps the tendon lubricated and moving properly. Inflammation or swelling of the sheath is known as tendon sheath inflammation or tenosynovitis. This condition is often treated with an injection into or around the sheath. This injection often consists of a corticosteroid with or without lidocaine. Corticosteroid(CS) are drugs that decrease inflammation and are given for a number of orthopaedic conditions to decrease symptoms of the underlying disease. Lidocaine is also a drug that blocks the pain response, although it only blocks it momentarily. The study aims to determine if corticosteroid injection alone is as effective as corticosteroid combined with lidocaine for the relief of tenosynovitis of the upper extremity.

The study plans to enroll 1000 pts with tendinopathies of upper extremities and nerve entrapments and will be followed up in clinic 2 weeks and 6 weeks after the injection. During the clinic visits the Visual Analog Scale for pain (VAS-pain), range of motion (ROM), strength, and patient reported outcome data will be collected and any complications will be noted. Patients will also utilize a pain journal to track VAS-pain over the first 7 post-injection days.

Arms: arm 1: Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition arm 2: Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Interventions: intervention 1: Treatment Group: Corticosteroid injection intervention 2: Control Group (corticosteroid alone) intervention 3: Treatment Group: Lidocaine
Intervention descriptions: intervention 1: Subjects will receive a corticosteroid injection that is 40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone. intervention 2: Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) . intervention 3: Subjects will receive an injection of lidocaine (1% lidocaine HCl).

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
 
 
 
 
Corticosteroid Injections for the Treatment of Common Upper Extremity Pathologies, 
With or Without Lidocaine: A Randomized Control Trial 
 
NTC# NCT03704584 
 
 
Date: 7/9/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Project Summary 
 
Title of Study: Corticosteroid Injections for the Treatment of Common Upper Extremity 
Pathologies, With or Without Lidocaine: A Randomized Control Trial 
 
Principle Investigator: Charles Daly MD 
Co-Investigators: Kevin Xavier Farley, Albert Thomas Anastasio, Michael Gottschalk MD, Eric 
Wagner MD, Emily Allard-Phillips 
Study Coordinators: Ericka Ortega, Tiffany Dumas, Jared O’neal, Lauren Glenney 
Version date: 7/9/2019 
 
Lay Summary: A tendon is a type of tissue that connects your muscles to your bones. These 
tissues help control actions such as running, jumping, grasping, and lifting. Without tendons, you 
wouldn’t be able to control the movement of your body. A protective layer known as synovium 
covers tendons. This sheath produces fluid, which keeps the tendon lubricated and moving 
properly. Inflammation or swelling of the sheath is known as tendon sheath inflammation or 
tenosynovitis. This condition is often treated with an injection into or around the sheath. This 
injection often consists of a corticosteroid with or without lidocaine. Corticosteroid are drugs that 
decrease inflammation and are given for a number of orthopaedic conditions to decrease symptoms 
of the underlying disease. Lidocaine is also a drug that blocks the pain response, although it only 
blocks it momentarily. Our study aims to determine if corticosteroid injection alone is as effective 
as corticosteroid combined with lidocaine for the relief of tenosynovitis of the upper extremity.  
 
Precis/Abstract: 
  
This will be a randomized control trial to study the efficacy of a combined lidocaine and 
corticosteroid injection on pain, range of motion, and patient reported outcomes versus a 
corticosteroid injection alone for the treatment of common upper extremity tendinopathies and 
nerve entrapments that are often treated with a combination of these injectates.  Patients will be 
assigned randomly to a control group (corticosteroid injection alone) or the treatment group 
(lidocaine plus corticosteroid injection). At the initial injection a 10-point likert scale prior to and 
after the injection will be administered.  The patients will be followed up at 6 weeks after the 
injection, at which time the Visual Analog Scale for pain (VAS-pain), range of motion (ROM), 
and patient reported outcome data will be collected and any complications will be noted. Patients 
will also utilize a pain journal to track VAS-pain over the first 7 post-injection days. We 
hypothesize that those who receive lidocaine plus corticosteroid injection will be non-inferior in 
regards to pain, range of motion (ROM), failure of injection requiring surgery, and patient reported 
outcome scores compared with patients who received corticosteroid injection alone.  
 
Background and Significance:  
 
Tenosynovitis is a common ailment of the upper extremity resulting in pain around the 
affected joint due to injury to the tendon sheath. One of the most common manifestations of 
tenosynovitis is trigger finger. Trigger finger is an extremely common pathology encountered by 
primary care providers and hand surgeons. Reported incidence of 28 cases per 100,000 has been 
documented [1]. This entity occurs when the contents of the flexor tendon sheath do not fit cleanly 


within the sheath, causing friction on movement of the fingers. Progression from a clicking or 
locking sensation to complete inability to flex or extend the finger (hence the designation “trigger 
finger”) occurs over the course of the disease. Therefore, triggering may not be initially noted on 
exam. Pain from this pathology can be experienced at the proximal interphalangeal joint, the 
metacarpophalangeal joint, or even the palm [2]. Reported increases in rates have been 
documented in diabetics, cases of repetitive trauma, those with renal and thyroid disease, and 
individuals with inflammatory conditions [3].  
 
The cause of trigger finger is poorly understood, with early studies identifying the 
condition as a form of tenosynovitis on histologic analysis. More recent studies have identified a 
lack of inflammatory cells, suggesting an abnormality in proliferation of fibrocartilage rather than 
a primary inflammatory condition [4]. Treatment of trigger finger has been studied extensively, 
but few evidence based guidelines exist for the treatment of this disease process [1]. Current 
treatment modalities are diverse and numerous, including non-operative management (splinting, 
stretching techniques, heat therapy, electric stimulation therapy, acupuncture, corticosteroid 
injection, and high-intensity focused ultrasound aimed at degrading the fibrosis surrounding the 
tendon sheath) and operative management (with open, percutaneous, and endoscopic methodology 
all having been described) [1, 5]. In 2017, Amirfeyz et al. proposed an evidenced based treatment 
guideline for trigger finger, with the first line treatment listed as “steroid and local anesthetic 
injection” followed by open operative management upon either failure of corticosteroid injection 
or patient refusal of corticosteroid injection [1].  
 
This treatment algorithm reflects existing research regarding treatment of trigger finger: 
corticosteroid injection for trigger finger has been studied extensively [6-25]. However, few well, 
randomized control trials have been undertaken comparing corticosteroid injection to placebo. Of 
the trials that have been done, both studies indicated improved outcomes with a combined injectate 
of corticosteroid with lidocaine versus just lidocaine alone [26, 27]. The long term efficacy of 
steroid injection is reasonable, with success rates as high as 69% [8]. That said, many patients will 
experience return of their symptoms and will go on to need open surgical treatment for recurrent 
trigger finger [3].  
While several studies have compared corticosteroid injection with lidocaine to lidocaine 
injection alone, to date, no study has evaluated the effectiveness of a corticosteroid injection either 
with or without lidocaine. Our study aims to evaluate whether or not lidocaine in the injectate 
combined with corticosteroid improves patient reported outcomes and recurrence of pain and 
morbidity from trigger finger as compared with corticosteroid injection alone.  
In addition, similar pathologies exist where the role of lidocaine remains vague. One such 
pathology is de Quervain tenosynovitis. de Quervain tendinopathy affects the abductor pollicis 
longus (APL) and extensor pollicis brevis (EPB) tendons in the first extensor compartment at the 
styloid process of the radius. It is characterized by pain or tenderness at the radial side of the wrist. 
Although de Quervain tendinopathy is often attributed to overuse or repetitive movements of the 
wrist or thumb, the cause is generally unknown. It most commonly affects woman between the 
ages of 30-50 years old [28]. 
 
A small randomized trial found that glucocorticoid injections resulted in significantly better 
symptom improvement compared with placebo one week after injection [29]. Among those who 
responded to glucocorticoid injections, the beneficial effects were maintained during the 12-month 
follow-up period. Another randomized trial also found that splinting plus glucocorticoid injection 
was better than splinting alone [30]. Most patients experience pain relief after a single 
glucocorticoid injection [30, 31] In patients with recurrent symptoms after initial relief with the 


first glucocorticoid injection, a second injection may provide benefit. However, limited evidence 
is available about the role of lidocaine during these injections. We further aim to elucidate the role 
of corticosteroid and lidocaine versus corticosteroid alone in the treatment of de Quervain 
tenosynovitis.  
 
Furthermore, the role of lidocaine with corticosteroid in the treatment of a number of other 
tenosynovitides remains ambiguous. These include tenosynovitis of the shoulder, biceps, elbow, 
wrist, thumb, carpometacarpal, midcarpal, elbow, and small joints of the hand (PIP, DIP, MP). We 
aim to ascertain whether the corticosteroid and lidocaine injectate together is as effective as 
corticosteroid in the treatment of these tenosynovitides. For all these pathologies corticosteroid 
with or without lidocaine is standard of care for orthopaedic hand and shoulder surgeons and the 
use of either treatment regimen is based on personal preference by the surgeon.  
 
Objectives: 
1. Determine differences in pain scores / likert scale at the time of injection and during follow up 
in the corticosteroid plus lidocaine group as compared to the corticosteroid alone group. 
2. Determine differences in range of motion of the affected joint in the corticosteroid plus lidocaine 
group as compared to the corticosteroid alone group. 
3. Determine differences in patient-reported outcome scores (VAS-pain, qDASH, PRWE, ASES, 
SF12, EQOL) in the corticosteroid plus lidocaine group as compared to the corticosteroid alone 
group. 
4. Report patient characteristics associated with efficacy of addition of lidocaine to corticosteroid 
injectate for pain and ROM resolution (type of injury, affected joint, age, BMI, comorbidities, 
etc.). 
  
Hypotheses: 
 
Hypothesis0: Corticosteroid injectate alone will result in statistically significant reduced pain 
scores as compared to corticosteroid with lidocaine for the treatment of tenosynovitis. 
Hypothesis1: Lidocaine plus corticosteroid injectate will result in equivalent requirements for 
repeat injection or conversion to surgery as compared with corticosteroid injectate alone for the 
treatment of tenosynovitis.  
Hypothesis2: Lidocaine plus corticosteroid injectate will result in equivalent patient reported 
outcomes scores as compared to corticosteroid alone for the treatment of tenosynovitis. 
Hypothesis3: Lidocaine plus corticosteroid injectate will result in equivocal patient-reported 
outcome scores, ROM, and pain reduction as compared to corticosteroid alone for the treatment of 
tenosynovitis.  
 
Study Design 
  
This will be a randomized control trial of a group of patients with upper extremity tenosynovitides 
treated with either lidocaine plus corticosteroid or corticosteroid injection alone by upper extremity 
fellowship trained surgeons at Emory University. Patients will be randomly assigned to one of two 
groups at the time of treatment: 1. Lidocaine Plus Corticosteroid and 2. Corticosteroid Alone. A 
random allocation sequence, concealed in consecutively numbered, opaque, sealed envelopes, 
determining active treatment or placebo, will be computer generated. Written-informed consent 
will be obtained from patients prior to injection.  


 
Patients in the Corticosteroid group will be treated with a 40 mg/mL injection of corticosteroid 
following sterile preparation. The volume of injectate differs for each tenosynovitis being treated. 
For example, trigger finger patients in the corticosteroid alone group will receive a 1mL of injectate 
total (consisting of 1 mL of 40mg/mL triamcinolone).  
 
Patients in the Corticosteroid and Lidocaine group will be treated with a 40 mg/mL injection of 
corticosteroid combined with 1% lidocaine. The volume of injectate differs for each tenosynovitis 
being treated. For example, patients being treated for trigger finger will receive 0.5 mL of 1% 
lidocaine and 1 mL of 40mg/mL triamcinolone.  
 
Needle size and insertion site of needle differs for each tenosynovitis being treated. For trigger 
finger specifically, needle injections will be performed with an appropriately sized needle inserted 
over the A1 pulley at a 45-degree angle. The injection will be done with the same technique for 
both groups by the attending physician. The medication will be injected extra-synovially in order 
to make the treatment more reproducible. This method of injection has been supported in previous 
studies. 
 
Outcome Measures:  
  
- 
Likert Scale: A 10-point likert scale will be asked before and after injection which has been 
previously validated in other studies looking at efficacy and pain surrounding injections of the 
upper extermity. 
 
- Pain Assessment: A pain assessment will be assessed before performing the injection, at the time 
of injection, and at each subsequent follow up visit. Pain scores will be obtained via the Visual 
Analog Pain Scale (VAS-pain), which is ranked from 0 (no pain) to 10 (highest amount of pain). 
Pain will be assessed at rest and active movement of the affected joint. Patient will also be asked 
to fill out the VAS-pain score twice daily in a pain journal (once in the morning and once at night) 
each day until post-injection day 7. 
 
- qDASH/PRWE/ASES/SF12/EQOL score: These scores will be administered at each clinic 
follow up. They will also be administered 6 week after the injectate has been performed. 
 
- Need for subsequent reinjection and surgical operation will be recorded. 
  
These scores, specifically the 10-point likert, will also be assessed before performing the injection, 
immediately after the injection, and again at the various follow up appointments. During clinic 
follow up we will monitor for complications.  
  
Inclusion Criteria:  
- All adult clinical patients of Emory upper extremity surgeons undergoing injection for treatment 
of the following who are willing to participate in the study will be included in the study: 
Tenosynovitis of the upper extremity, including but not limited to, the shoulder, biceps, elbow, 
wrist, thumb, carpometacarpal, midcarpal, elbow, and small joints of the hand (PIP, DIP, MP). 
- Between the ages of 18 years and 95 years.  


- For trigger finger: patients with a diagnosis of stenosing tenosynovitis based on a history of 
triggering and the presence of tenderness over the A1 pulley upon clinical examination. All 
patients, based on the Quinnell grading of trigger finger see in the figure below, will be included. 
 
 
 
Exclusion Criteria:  
- Patients who are minors, vulnerable subjects, or who are not willing to consent to participate in 
the study. 
- Allergies to glucocorticoids, current daily use of glucocorticoids or strong opioids (morphine, 
fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, and meperidine), 
severe diabetic neuropathy of the hand influencing pain perception, rheumatoid arthritis, and 
neurological or psychiatric diseases, potentially influencing pain perception.  
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or 
procedures. 
  
Statistical Analysis: 
  
Data will be stored on an excel spreadsheet. We will collect the name, medical record number, age 
at time of surgery, ethnicity, gender, BMI, presence of diabetes, Quinnell grading of trigger finger, 
smoking status, pre-injection VAS-pain, post-injection VAS-pain, 10 point likert scale, 
complications, and need for repeat injection or surgical release. It is possible that other variables 
may be added depending on analysis. Each variable will be used as a nominal variable when 
possible (e.g. smoking status) or a continuous variable if needed (e.g. VAS-pain, patient related 
outcome scores). For some statistical calculations we may break up the continuous variables in to 
ranges (e.g. Ages 15-20, 25-30). We will perform statistical analysis using unpaired, 2-tailed 
Student t test to compare means for normally distributed data, Kruskal-Wallis test to compare 
medians of non-normally distributed data, and chi-square test to compare proportions. Statistical 
significance will be interpreted as P < .05. Confidence intervals will be calculated with a 
confidence level of 95%. 
 
Specifically, the 2 groups will be compared using the Mann-Whitney U test to analyze the 
difference between the post-injection VAS scores. The Wilcoxon sign-rank test will be used to test 
the difference between the treatment and control group for pain and patient related outcomes.  
  
The minimally clinically important difference (MCID) varies for each outcome measure.  
Therefore, for the purposes of a power analysis, we will use the VAS-pain at the time of injection 
as the primary outcome. A similar study was published in 2017 from Earp et al. comparing needle-
free jet lidocaine for pre-corticosteroid injection anesthesia with simultaneous lidocaine and 
corticosteroid injection. Using the results of this study as a metric, for the purposes of our study, 
to determine a 1-point change in VAS (4.5 to 3.5) with the reported standard deviation of 2 (SEM 


was 0.4, with 30 subjects in each group) in the Earp et al. study, the number needed to treat to 
detect a difference between the treatment and placebo group would be 63 [32]. Therefore, we aim 
for a sample size of 63 patients for each possible tenosynovitis described in the inclusion criteria.  
 
In total, we plan to enroll 1000 patients total into this study when combining all possible 
tenosynovitides encountered at Emory. These outcomes will be feasible to obtain in a reasonable 
time frame given the high volume of patients treated for tenosynovitis of all types at Emory. 
Patients will be grouped together for analysis and also broken into subgroups for sub-analysis 
based on primary diagnosis for injection.  
 
JMP Pro Software or SPSS will be used to analyze the data and perform the statistics. 
  
Risks to participation 
  
Risks to participation include breach of confidentiality from PHI used to conduct the study.  Every 
effort will be used to scrub data when possible and to use subject numbers/unique identifiers when 
possible.  
  
As stated above, the first line treatment for trigger finger is corticosteroid injection with lidocaine, 
although there are a significant proportion of hand surgeons who inject corticosteroid alone. As no 
study has evaluated the efficacy of lidocaine mixed with the injectate versus corticosteroid alone, 
our study does not constitute deviation from current status quo of best medical practice for the 
treatment of trigger finger. Both treatment options are considered standard of care and it is 
solely based on physician preference for which regimen is chosen as an injectate. Patients will 
be notified of any potential risks with signed written consent as they would before any standard 
corticosteroid injection for the treatment of trigger finger. They will also be asked to sign an 
additional consent form agreeing to participate in our study outlining the nature of the study and 
the fact that no deviation from current best medical practice will occur throughout the course of 
the study.  
  
Benefits to future subjects or science 
By identifying whether or not lidocaine combined with corticosteroid injectate leads to improved 
patient outcomes as compared with corticosteroid injection alone, we will be able to educate 
physicians and patients on best medical practice for treatment of trigger finger. Additionally, as 
lidocaine has been reported to cause significant burning during injection, if there is no additional 
benefit to addition of lidocaine to corticosteroid injection, we will be able to spare future patients 
the discomfort of combining the injectate with lidocaine.  
  
Data safety and monitoring plan: 
  
Patients will be followed up closely in clinic at 2 weeks and 6 weeks post-injection to ensure 
patients did not experience side effects from the injection and to assess for efficacy of the injection. 
A low dose of corticosteroid and lidocaine is being utilized and we do not anticipate adverse 
effects.  
  


Patients will have the ability to remove themselves from this study either completely or partially, 
and these options will be elucidated on the written consent form.  
  
Every effort will be made to keep data confidential. All data will be kept in encrypted files on 
password protected devices and when possible on Emory Box and accessible only by Institutional 
Review Board (IRB) approved study personnel. Each file and folder is password encrypted and 
personnel must login via passwords to gain access to the folders. When data collection is complete, 
all identifiers will be removed from the data set prior to analysis. If there is a data breach the study 
personnel will report this immediately to the IRB. 
  
Government agencies and Emory employees overseeing proper study conduct may access study 
records. These may include personnel from the Office for Human Research Protections, the Emory 
Institutional Review Board, the Emory Office of Research Compliance, the Office for Clinical 
Research, and the Clinical Trials Audit & Compliance Office. 
  
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