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

September 14, 2022 updated by: Charles A Daly, Emory University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • 12 Executive Park Drive
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic A, Clifton Road Clinic
      • Atlanta, Georgia, United States, 30329
        • Emory Healthcare Orthopaedics and Spine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment Group (corticosteroid injection plus lidocaine)
Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition
Drug: Treatment Group: Corticosteroid injection
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.
Other Names:
  • kenalog
  • depo-medrol
Drug: Treatment Group: Lidocaine
Subjects will receive an injection of lidocaine (1% lidocaine HCl).
Other Names:
  • Xylocaine
Other: Control Group (corticosteroid alone)
Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition
Drug: Control Group (corticosteroid alone)
Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
Other Names:
  • Methylprednisolone acetate injectable suspension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Pre injection, Post injection day, 2 weeks and at 6 weeks
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.
Pre injection, Post injection day, 2 weeks and at 6 weeks
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Time Frame: Post injection day (1-7), 2 weeks and at 6 weeks post intervention
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.
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
Time Frame: 2 weeks and at 6 weeks post intervention
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.
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
Time Frame: 2 weeks and at 6 weeks post intervention
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).
2 weeks and at 6 weeks post intervention
American Shoulder and Elbow Surgeons Shoulder Score (ASES) at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Time Frame: 2 weeks and at 6 weeks post intervention
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)
2 weeks and at 6 weeks post intervention
Short Form Health Survey (SF-12) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Time Frame: 2 weeks and at 6 weeks post intervention
The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
2 weeks and at 6 weeks post intervention
Number of Patients With Subsequent Reinjection and Surgical Operation
Time Frame: End of follow up (6 weeks post intervention)
The number of patients with subsequent reinjection and surgical operation was collected during follow up.
End of follow up (6 weeks post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charles Daly, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00104900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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