Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone



Status:Recruiting
Healthy:No
Age Range:18 - 95
Updated:2/3/2019
Start Date:March 2019
End Date:August 2021
Contact:Charles Daly, MD
Email:charles.a.daly@emory.edu
Phone:404-919-6168

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Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine

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.

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.

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.

- 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 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.
We found this trial at
3
sites
Atlanta, Georgia 30329
Principal Investigator: Charles Daly, MD
Phone: 404-919-6168
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Atlanta, GA
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Atlanta, Georgia 30322
Principal Investigator: Charles Daly, MD
Phone: 404-919-6168
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30329
Principal Investigator: Charles Daly, MD
Phone: 404-919-6168
?
mi
from
Atlanta, GA
Click here to add this to my saved trials