Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

Rush

Status: Terminated

Conditions: Injection; Biceps Tendonitis

Treatments: Procedure: Landmark-guidance; Procedure: Ultrasound-guidance; Drug: Lidocaine 1%; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02591953

15101504

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

Ultrasound-guided Injection

Experimental group

Description:

Injection performed with ultrasound-guidance

Treatment:

Drug: Lidocaine 1%

Drug: Methylprednisolone

Procedure: Ultrasound-guidance

Landmark-guided Injection

Active Comparator group

Description:

Injection performed at point of maximal tenderness along biceps tendon

Treatment:

Drug: Lidocaine 1%

Procedure: Landmark-guidance

Drug: Methylprednisolone