Biceps Tendonitis, Injection
Conditions
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.
Interventions
PROCEDUREUltrasound-guidance
Using ultrasound-guidance to perform a corticosteroid injection
PROCEDURELandmark-guidance
Using landmark-guidance to perform a corticosteroid injection
DRUGMethylprednisolone
Corticosteroid used in injection (40 mg)
DRUGLidocaine 1%
Anesthesic used in injection
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Simple Shoulder Test | 1 year | 12 question assessment of shoulder function with yes or no answers |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrasound-guided Injection Injection performed with ultrasound-guidance
Ultrasound-guidance: Using ultrasound-guidance to perform a corticosteroid injection
Methylprednisolone: Corticosteroid used in injection (40 mg)
Lidocaine 1%: Anesthesic used in injection | 12 |
| Landmark-guided Injection Injection performed at point of maximal tenderness along biceps tendon
Landmark-guidance: Using landmark-guidance to perform a corticosteroid injection
Methylprednisolone: Corticosteroid used in injection (40 mg)
Lidocaine 1%: Anesthesic used in injection | 10 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 6 |
Baseline characteristics
| Characteristic | Ultrasound-guided Injection | Landmark-guided Injection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 10 Participants | 22 Participants |
| Pain and Function Scores | NA units on a scale | NA units on a scale | NA units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
Primary
Simple Shoulder Test
12 question assessment of shoulder function with yes or no answers
Time frame: 1 year
Population: The study was terminated and data could not be analyzed as the department switched PRO companies. Access to the data was lost at that time.