Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-05-31

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.

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ultrasound-guided Injection

Injection performed with ultrasound-guidance

Group Type EXPERIMENTAL

Ultrasound-guidance

Intervention Type PROCEDURE

Using ultrasound-guidance to perform a corticosteroid injection

Methylprednisolone

Intervention Type DRUG

Corticosteroid used in injection (40 mg)

Lidocaine 1%

Intervention Type DRUG

Anesthesic used in injection

Landmark-guided Injection

Injection performed at point of maximal tenderness along biceps tendon

Group Type ACTIVE_COMPARATOR

Landmark-guidance

Intervention Type PROCEDURE

Using landmark-guidance to perform a corticosteroid injection

Methylprednisolone

Intervention Type DRUG

Corticosteroid used in injection (40 mg)

Lidocaine 1%

Intervention Type DRUG

Anesthesic used in injection

Interventions

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Ultrasound-guidance

Using ultrasound-guidance to perform a corticosteroid injection

Intervention Type PROCEDURE

Landmark-guidance

Using landmark-guidance to perform a corticosteroid injection

Intervention Type PROCEDURE

Methylprednisolone

Corticosteroid used in injection (40 mg)

Intervention Type DRUG

Lidocaine 1%

Anesthesic used in injection

Intervention Type DRUG

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