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Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

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ClinicalTrials.gov Identifier: NCT02591953
Recruitment Status : Terminated (Unable to meet enrollment and follow up criteria)
First Posted : October 30, 2015
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Jeremy A Alland, Rush University Medical Center

Brief Summary:
Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.

Condition or disease Intervention/treatment Phase
Biceps Tendonitis Injection Procedure: Ultrasound-guidance Procedure: Landmark-guidance Drug: Methylprednisolone Drug: Lidocaine 1% Not Applicable

Detailed Description:

Patients are diagnosed with biceps tendinitis in the outpatient clinic. After diagnosis, all the patients that meet inclusion/exclusion criteria will be offered to enroll in the study. Study will be described to the patient with regard to protocol and consent. All questions regarding the study will be answered, and it will be explicitly described that the study involvement will not change clinical care. It will be explained that investigators expect a follow up appointment at minimum at three weeks and three months. There may be further follow up requested up to 1 year from enrollment.

After collection of informed consent, the patient will be randomized to either ultrasound-guided or landmark-guided injection. The patient will complete clinical scores at the initial visit prior to the injection. After injection, the patient will have follow up scheduled for three weeks and three months. To ensure patient blinding, an ultrasound will be placed on the patient for both groups, but only active imaging with be performed for the ultrasound-guided patient group. For clinician blinding, a different clinician than the injecting clinician will perform the follow up examinations. The patient is instructed to not seek additional injections or physical therapy during the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2015
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound-guided Injection
Injection performed with ultrasound-guidance
Procedure: Ultrasound-guidance
Using ultrasound-guidance to perform a corticosteroid injection

Drug: Methylprednisolone
Corticosteroid used in injection (40 mg)

Drug: Lidocaine 1%
Anesthesic used in injection

Active Comparator: Landmark-guided Injection
Injection performed at point of maximal tenderness along biceps tendon
Procedure: Landmark-guidance
Using landmark-guidance to perform a corticosteroid injection

Drug: Methylprednisolone
Corticosteroid used in injection (40 mg)

Drug: Lidocaine 1%
Anesthesic used in injection




Primary Outcome Measures :
  1. ASES Shoulder Score [ Time Frame: 1 year ]
    Orthopedic Pain and Function Scale


Secondary Outcome Measures :
  1. Speed's Test [ Time Frame: 1 year ]
    Physical Exam maneuver measured as positive or negative

  2. Tenderness over Bicepital Groove [ Time Frame: 1 year ]
    Physical exam maneuver measured as yes or no

  3. Simple Shoulder Test [ Time Frame: 1 year ]
    12 question assessment of shoulder function with yes or no answers



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain at intertubercular groove
  • Anterior humeral pain
  • Positive Speed's Test
  • Bicep's tendinitis is primary diagnosis for patient
  • Patient agrees to follow up and consent

Exclusion Criteria:

  • Prior biceps surgery or injections
  • Prior SLAP or labral repair
  • Concomitant shoulder arthroplasty

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): NCT02591953


Locations
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United States, Illinois
Midwest Orthopeadics at Rush
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Additional Information:
Publications:
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Responsible Party: Jeremy A Alland, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02591953    
Other Study ID Numbers: 15101504
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Lidocaine
Prednisolone hemisuccinate
Prednisolone phosphate
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
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones