Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

Not Applicable

Terminated

• Conditions: Injection; Biceps Tendonitis
• Interventions: Procedure: Ultrasound-guidance; Procedure: Landmark-guidance; Drug: Methylprednisolone; Drug: Lidocaine 1%

• Registration Number: NCT02591953
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Start: 2015-11
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Results First Submitted: 2021-05-25
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Results First Posted: 2022-07-18
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided Injection	Ultrasound-guidance	Injection performed with ultrasound-guidance
Landmark-guided Injection	Landmark-guidance	Injection performed at point of maximal tenderness along biceps tendon
Ultrasound-guided Injection	Lidocaine 1%	Injection performed with ultrasound-guidance
Landmark-guided Injection	Lidocaine 1%	Injection performed at point of maximal tenderness along biceps tendon
Landmark-guided Injection	Methylprednisolone	Injection performed at point of maximal tenderness along biceps tendon
Ultrasound-guided Injection	Methylprednisolone	Injection performed with ultrasound-guidance

Primary Outcome Measures

Name	Time	Method
Simple Shoulder Test	1 year	12 question assessment of shoulder function with yes or no answers

Trial Locations

Locations (1)

Midwest Orthopeadics at Rush; 🇺🇸 Chicago, Illinois, United States