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

Rush

Status: Withdrawn

Conditions: Subacromial Impingement Syndrome; Rotator Cuff

Treatments: Drug: Saline; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02693444

15081703

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

Subacromial Lidocaine Injection

Active Comparator group

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

Treatment:

Drug: Lidocaine

Subacromial Saline Injection

Placebo Comparator group

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

Treatment:

Drug: Saline