Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

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

Detailed Description
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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.

Conditions
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Biceps Tendonitis, Injection

Intervention / Treatment
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* Procedure: Ultrasound-guidance
* Procedure: Landmark-guidance
* Drug: Methylprednisolone
* Drug: Lidocaine 1%


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound-guided Injection<br>Injection performed with ultrasound-guidance | Procedure: Ultrasound-guidance<br>* Using ultrasound-guidance to perform a corticosteroid injection<br>Drug: Methylprednisolone<br>* Corticosteroid used in injection (40 mg)<br>Drug: Lidocaine 1%<br>* Anesthesic used in injection<br>|
| Active Comparator: Landmark-guided Injection<br>Injection performed at point of maximal tenderness along biceps tendon | Procedure: Landmark-guidance<br>* Using landmark-guidance to perform a corticosteroid injection<br>Drug: Methylprednisolone<br>* Corticosteroid used in injection (40 mg)<br>Drug: Lidocaine 1%<br>* Anesthesic used in injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simple Shoulder Test | 12 question assessment of shoulder function with yes or no answers | 1 year |