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

December 1, 2020 updated by: Rush University Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subacromial Lidocaine Injection
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
Drug: Lidocaine
Placebo Comparator: Subacromial Saline Injection
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
Drug: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant Shoulder Score
Time Frame: 10 minutes following injection
Validated outcome score assessing pain and function of shoulder
10 minutes following injection

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Brian Forsythe, MD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 2, 2016

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

April 27, 2017

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15081703

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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