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

Not Applicable

Withdrawn

• Conditions: Subacromial Impingement Syndrome; Rotator Cuff
• Interventions: Drug: Saline; Drug: Lidocaine

• Registration Number: NCT02693444
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-02-26
• Study Start: 2016-03-02
• Primary Completion: 2017-02-28
• Study Completion: 2017-04-27
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subacromial Saline Injection	Saline	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
Subacromial Lidocaine Injection	Lidocaine	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

Primary Outcome Measures

Name	Time	Method
Constant Shoulder Score	10 minutes following injection	Validated outcome score assessing pain and function of shoulder