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

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ClinicalTrials.gov Identifier: NCT02693444
Recruitment Status : Withdrawn (Low pool of subjects)
First Posted : February 26, 2016
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Subacromial Impingement Syndrome Drug: Lidocaine Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears
Actual Study Start Date : March 2, 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : April 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Subacromial Lidocaine Injection
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
Placebo Comparator: Subacromial Saline Injection
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



Primary Outcome Measures :
  1. Constant Shoulder Score [ Time Frame: 10 minutes following injection ]
    Validated outcome score assessing pain and function of shoulder



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693444


Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Brian Forsythe, MD Rush University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02693444    
Other Study ID Numbers: 15081703
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action