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NCT02693444 Clinical Trial

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

Subacromial Impingement Syndrome Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02693444
Other study ID # 15081703
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2, 2016
Est. completion date April 27, 2017

Study information
Verified date December 2020
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 27, 2017
Est. primary completion date February 28, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine

• Saline

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rush University Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Constant Shoulder Score Validated outcome score assessing pain and function of shoulder 10 minutes following injection
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