Clinical trial NCT02591953
Conditions: Biceps Tendonitis Injection
Sponsor: Rush University Medical Center
Start date: 2015-11-01; Completion date: 2019-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Injection performed with ultrasound-guidance arm 2: Injection performed at point of maximal tenderness along biceps tendon
Interventions: intervention 1: Ultrasound-guidance intervention 2: Landmark-guidance intervention 3: Methylprednisolone intervention 4: Lidocaine 1%
Intervention descriptions: intervention 1: Using ultrasound-guidance to perform a corticosteroid injection intervention 2: Using landmark-guidance to perform a corticosteroid injection intervention 3: Corticosteroid used in injection (40 mg) intervention 4: Anesthesic used in injection

Protocol documents:
Prot_000.pdf: 
Randomized Prospective Clinical Analysis of Ultrasound-guided vs. Landmark-
guided Biceps Corticosteroid Injections
PI: 
Jeremy Alland, MD
Co-investigators:
A. Romeo, MD, B. Cole, MD
Introduction
Biceps tendinitis typically includes pain in the anterior shoulder that is reproduced 
with provocative maneuvers. Corticosteroid injections have been a mainstay of 
conservative management of biceps tendonitis. Many physicians have recently added 
ultrasound guidance to the injection to ensure accurate placement in the tendon sheath. 
Studies have shown that ultrasound guidance is more accurate than landmark guidance. 
However, the clinical significance of the accurate placement of the injection into the sheath 
is not clear. 
Study Aim
Using randomization, prospectively determine superiority of either ultrasound-
guided or landmark-guided biceps corticosteroid injections with regard to various clinical 
variables described at three weeks and three months.
Hypothesis
There will be a significant clinical difference in outcomes with ultrasound-guided 
being superior tolandmark-guided biceps corticosteroid injections at threeweeks and 
threemonth follow up. 
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
Methods
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 
ORA: 15101504-IRB01   Date IRB Approved: 3/27/2016


study involvement will not change clinical care. It will be explained that we expect a follow 
up appointment in three weeks and three months.
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 during the study.
Enrollment:
40-60 patients will be enrolled
Data collection will be performed as described below:
Pre-Procedural Data:
- Clinical Assessment Information (Symptomatic and asymptomatic side)
- Clinical Questionnaires
o
Pain VAS
o
ASES
o
SST
o
SANE
-
Biceps Specific Questions
o
Fatigue pain
o
Anterior Shoulder Pain (0-10)
o
Presence of spasms
-
Provocative Maneuvers
o
Tenderness at the bicipital groove with arm at neutral
o
O’Brien’s, Speeds, Yergason’s test
Post-Procedural Evaluation (same data as pre-operative visit)
- 3weeks
- 3 months
All data will be stored on a dedicated research computer on a local hard drive that 
requires password access, which only study personnel will possess. All patient identifying 
data will be removed and only demographic information will be included with an 
anonymous patient ID being ascribed.  Statistical analysis will be performed in a blinded 
manner until results are final. These will include non-parametric comparison of groups 
with regard to all outcomes.
ORA: 15101504-IRB01   Date IRB Approved: 3/27/2016