Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections
Study Details
Study Description
Brief Summary
Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ultrasound-guided Injection Injection performed with ultrasound-guidance |
Procedure: Ultrasound-guidance
Using ultrasound-guidance to perform a corticosteroid injection
Drug: Methylprednisolone
Corticosteroid used in injection (40 mg)
Drug: Lidocaine 1%
Anesthesic used in injection
|
Active Comparator: Landmark-guided Injection Injection performed at point of maximal tenderness along biceps tendon |
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
|
Outcome Measures
Primary Outcome Measures
- Simple Shoulder Test [1 year]
12 question assessment of shoulder function with yes or no answers
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Midwest Orthopeadics at Rush | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- Rush University Medical Center
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Aly AR, Rajasekaran S, Ashworth N. Ultrasound-guided shoulder girdle injections are more accurate and more effective than landmark-guided injections: a systematic review and meta-analysis. Br J Sports Med. 2015 Aug;49(16):1042-9. doi: 10.1136/bjsports-2014-093573. Epub 2014 Nov 17. Review.
- Hashiuchi T, Sakurai G, Morimoto M, Komei T, Takakura Y, Tanaka Y. Accuracy of the biceps tendon sheath injection: ultrasound-guided or unguided injection? A randomized controlled trial. J Shoulder Elbow Surg. 2011 Oct;20(7):1069-73. doi: 10.1016/j.jse.2011.04.004. Epub 2011 Jul 22.
- Naredo E, Cabero F, Beneyto P, Cruz A, Mondéjar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14.
- Ucuncu F, Capkin E, Karkucak M, Ozden G, Cakirbay H, Tosun M, Guler M. A comparison of the effectiveness of landmark-guided injections and ultrasonography guided injections for shoulder pain. Clin J Pain. 2009 Nov-Dec;25(9):786-9. doi: 10.1097/AJP.0b013e3181acb0e4.
- Zhang J, Ebraheim N, Lause GE. Ultrasound-guided injection for the biceps brachii tendinitis: results and experience. Ultrasound Med Biol. 2011 May;37(5):729-33. doi: 10.1016/j.ultrasmedbio.2011.02.014. Epub 2011 Mar 31.
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Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Ultrasound-guided Injection | Landmark-guided Injection |
---|---|---|
Arm/Group Description | 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 | 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 |
Period Title: Overall Study | ||
STARTED | 12 | 10 |
COMPLETED | 6 | 4 |
NOT COMPLETED | 6 | 6 |
Baseline Characteristics
Arm/Group Title | Ultrasound-guided Injection | Landmark-guided Injection | Total |
---|---|---|---|
Arm/Group Description | 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 | 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 | Total of all reporting groups |
Overall Participants | 12 | 10 | 22 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
12
100%
|
10
100%
|
22
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
4
33.3%
|
3
30%
|
7
31.8%
|
Male |
8
66.7%
|
7
70%
|
15
68.2%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (participants) [Number] | |||
United States |
12
100%
|
10
100%
|
22
100%
|
Pain and Function Scores (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
Outcome Measures
Title | Simple Shoulder Test |
---|---|
Description | 12 question assessment of shoulder function with yes or no answers |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Results |
---|---|
Arm/Group Description | Results not reported |
Measure Participants | 0 |
Adverse Events
Time Frame | 1 year after injection | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Ultrasound-guided Injection | Landmark-guided Injection | ||
Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
Ultrasound-guided Injection | Landmark-guided Injection | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/12 (0%) | 0/10 (0%) | ||
Serious Adverse Events |
||||
Ultrasound-guided Injection | Landmark-guided Injection | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/12 (0%) | 0/10 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Ultrasound-guided Injection | Landmark-guided Injection | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/12 (0%) | 0/10 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Jeremy Alland |
---|---|
Organization | Rush |
Phone | 3124322434 |
jeremy.alland@rushortho.com |
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