NCT02693444

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

Withdrawn NA Last updated 3 December 2020

What this trial tests

NA trial testing Lidocaine in Rotator Cuff. Withdrawn.

Timeline

2 March 2016

Primary endpoint
28 February 2017

27 April 2017

Quick facts

Lead sponsor	Rush University Medical Center
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Start date	2 March 2016
Primary completion	28 February 2017
Estimated completion	27 April 2017

Drugs / interventions tested

• Lidocaine — full drug profile →
• Saline

Conditions studied

• Rotator Cuff — all drugs for Rotator Cuff →
• Subacromial Impingement Syndrome — all drugs for Subacromial Impingement Syndrome →

Sponsor

Rush University Medical Center

Who can join

18 and older, any sex, with Rotator Cuff or Subacromial Impingement Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Function Improves After Subacromial Injection of Local Anesthetic in Full-Thickness Rotator Cuff Tears: A Randomized Control Trial.
   Forsythe B, Agarwalla A, Puzzitiello RN, Patel BH, et al · · 2020 · cited 5× · PMID 31934594 · DOI 10.1177/2325967119892331