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Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears

Primary Purpose

Rotator Cuff, Subacromial Impingement Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine
Saline
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is determined to have a full thickness rotator cuff tear (1-3 cm), on the pre-operative MRI scan or found arthroscopically, and is scheduled to undergo arthroscopic surgical repair
  • Written informed consent is obtained

Exclusion Criteria:

  • Revision Surgery
  • Irreparable tear or partial tear
  • Subscapularis involvement
  • Any patient lacking decisional capability

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Subacromial Lidocaine Injection

    Subacromial Saline Injection

    Arm Description

    Both of your shoulders will be examined and evaluated (shoulder survey). Following the exam, you will be randomized (assigned by chance, similar to a coin toss) to receive a 10cc (2 teaspoon) subacromial injection of lidocaine, will be given under ultrasound (using sound waves) guidance to your affected shoulder. A repeat shoulder exam will be performed and recorded

    Both of your shoulders will be examined and evaluated (shoulder survey). Following the exam, you will be randomized (assigned by chance, similar to a coin toss) to receive a 10cc (2 teaspoon) subacromial injection of saline, will be given under ultrasound (using sound waves) guidance to your affected shoulder. A repeat shoulder exam will be performed and recorded

    Outcomes

    Primary Outcome Measures

    Constant Shoulder Score
    Validated outcome score assessing pain and function of shoulder

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2016
    Last Updated
    December 1, 2020
    Sponsor
    Rush University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02693444
    Brief Title
    Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears
    Official Title
    Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Low pool of subjects
    Study Start Date
    March 2, 2016 (Actual)
    Primary Completion Date
    February 28, 2017 (Actual)
    Study Completion Date
    April 27, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rush University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness. The level of pain is often a limiting factor when assessing shoulder range of motion and strength pre-operatively. Pain itself has even been a cause of weakness due to muscle atrophy. The purpose of this study is to further understand the effect pain has by measuring constant shoulder scores in patients before and after ultrasound guided subacromial (the outer end of the shoulder blade) injection of lidocaine (a local anesthetic or numbing agent) compared to saline (salt solution), in patients indicated for arthroscopic rotator cuff repair. The saline and lidocaine has been approved for use by the U.S. Food and Drug Administration (FDA). The constant shoulder score includes your level of pain, activity level, range of motion and strength measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff, Subacromial Impingement Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Subacromial Lidocaine Injection
    Arm Type
    Active Comparator
    Arm Description
    Both of your shoulders will be examined and evaluated (shoulder survey). Following the exam, you will be randomized (assigned by chance, similar to a coin toss) to receive a 10cc (2 teaspoon) subacromial injection of lidocaine, will be given under ultrasound (using sound waves) guidance to your affected shoulder. A repeat shoulder exam will be performed and recorded
    Arm Title
    Subacromial Saline Injection
    Arm Type
    Placebo Comparator
    Arm Description
    Both of your shoulders will be examined and evaluated (shoulder survey). Following the exam, you will be randomized (assigned by chance, similar to a coin toss) to receive a 10cc (2 teaspoon) subacromial injection of saline, will be given under ultrasound (using sound waves) guidance to your affected shoulder. A repeat shoulder exam will be performed and recorded
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Primary Outcome Measure Information:
    Title
    Constant Shoulder Score
    Description
    Validated outcome score assessing pain and function of shoulder
    Time Frame
    10 minutes following injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is determined to have a full thickness rotator cuff tear (1-3 cm), on the pre-operative MRI scan or found arthroscopically, and is scheduled to undergo arthroscopic surgical repair Written informed consent is obtained Exclusion Criteria: Revision Surgery Irreparable tear or partial tear Subscapularis involvement Any patient lacking decisional capability
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Forsythe, MD
    Organizational Affiliation
    Rush University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31934594
    Citation
    Forsythe B, Agarwalla A, Puzzitiello RN, Patel BH, Lu Y, Verma NN, Romeo AA, Cole BJ. Clinical Function Improves After Subacromial Injection of Local Anesthetic in Full-Thickness Rotator Cuff Tears: A Randomized Control Trial. Orthop J Sports Med. 2020 Jan 3;8(1):2325967119892331. doi: 10.1177/2325967119892331. eCollection 2020 Jan.
    Results Reference
    derived

    Learn more about this trial

    Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears

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