Clinical trial NCT03704584: Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone
Official title: Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Tenosynovitis
Keywords: orthopedic disorders
corticosteroids(CS)
Lidocaine
Injections
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, unblinded controlled clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
timeFrame: Pre injection, Post injection day, 2 weeks and at 6 weeks
measure: Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
timeFrame: Post injection day (1-7), 2 weeks and at 6 weeks post intervention
measure: Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
timeFrame: 2 weeks and at 6 weeks post intervention
measure: Patient-Rated Wrist Evaluation (PRWE) Score at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
timeFrame: 2 weeks and at 6 weeks post intervention
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES) at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
timeFrame: 2 weeks and at 6 weeks post intervention
measure: Short Form Health Survey (SF-12) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
timeFrame: 2 weeks and at 6 weeks post intervention
measure: Number of Patients With Subsequent Reinjection and Surgical Operation
timeFrame: End of follow up (6 weeks post intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic A, Clifton Road Clinic
state: Georgia
city: Atlanta
country: United States
facility: 12 Executive Park Drive
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare Orthopaedics and Spine Center
state: Georgia
Study officials:
affiliation: Emory University
name: Charles Daly, MD
role: PRINCIPAL_INVESTIGATOR
References: