NCT02591953

Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Biceps Tendonitis
• Injection

Interventions

Type	Name	Description
PROCEDURE	Ultrasound-guidance	Using ultrasound-guidance to perform a corticosteroid injection
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2015-10-30
• Last updated: 2022-07-18
• Results posted: 2022-07-18

Locations

1 site across 1 country: United States