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

NCT02693444 | Withdrawn

• 1 other identifier: 15081703
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff; Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

• Constant Shoulder Score

  Validated outcome score assessing pain and function of shoulder

  10 minutes following injection

Study Arms (2)

Subacromial Lidocaine Injection

ACTIVE COMPARATOR

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

Subacromial Saline Injection

PLACEBO COMPARATOR

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

Interventions

Lidocaine DRUG

Subacromial Lidocaine Injection

Saline DRUG

Subacromial Saline Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Revision Surgery
• Irreparable tear or partial tear
• Subscapularis involvement
• Any patient lacking decisional capability

Sponsors & Collaborators

• Rush University Medical Center: lead

Related Publications (1)

• Forsythe B, Agarwalla A, Puzzitiello RN, Patel BH, Lu Y, Verma NN, Romeo AA, Cole BJ. Clinical Function Improves After Subacromial Injection of Local Anesthetic in Full-Thickness Rotator Cuff Tears: A Randomized Control Trial. Orthop J Sports Med. 2020 Jan 3;8(1):2325967119892331. doi: 10.1177/2325967119892331. eCollection 2020 Jan.

  PMID: 31934594 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Brian Forsythe, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: March 2, 2016
• Primary Completion: February 28, 2017
• Study Completion: April 27, 2017
• Last Updated: December 3, 2020

Record last verified: 2020-12