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

Phase 4TerminatedNCT03704584

Emory University62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tenosynovitis

Interventions

Treatment Group: Corticosteroid injectionDRUG

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.

Control Group (corticosteroid alone)DRUG

Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .

Treatment Group: LidocaineDRUG

Subjects will receive an injection of lidocaine (1% lidocaine HCl).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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.

Locations (3)

Emory Clinic A, Clifton Road Clinic

Atlanta, Georgia, United States

12 Executive Park Drive

Atlanta, Georgia, United States

Emory Healthcare Orthopaedics and Spine Center

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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

Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants.

Time frame: Pre injection, Post injection day, 2 weeks and at 6 weeks

Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7

Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented.

Time frame: Post injection day (1-7), 2 weeks and at 6 weeks post intervention

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

The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated \[(sum of n responses/n) - 1\] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined.

Time frame: 2 weeks and at 6 weeks post intervention

Patient-Rated Wrist Evaluation (PRWE) Score at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

The Patient-Related Wrist Evaluation is a score for the measurement of pain and function after injury to the wrist. The PRWE is a 15-item questionnaire that allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Total Score = Sum of pain+ function scores (Best Score = 0, Worst Score = 100).

Data from ClinicalTrials.gov

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