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Unable to meet enrollment and follow up criteria
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Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided Injection | Experimental | Injection performed with ultrasound-guidance |
|
| Landmark-guided Injection | Active Comparator | Injection performed at point of maximal tenderness along biceps tendon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guidance | Procedure | Using ultrasound-guidance to perform a corticosteroid injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Simple Shoulder Test | 12 question assessment of shoulder function with yes or no answers | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Orthopeadics at Rush | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21782470 | Background | 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. | |
| 21458143 | Background | 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. |
| Label | URL |
|---|---|
| AMSSM Statement of Interventional Musculoskeletal Ultrasound | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Landmark-guided Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Simple Shoulder Test | 12 question assessment of shoulder function with yes or no answers | 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. | Posted | 1 year |
|
|
1 year after injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeremy Alland | Rush | 3124322434 | jeremy.alland@rushortho.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2016 | May 25, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Landmark-guidance | Procedure | Using landmark-guidance to perform a corticosteroid injection |
|
| Methylprednisolone | Drug | Corticosteroid used in injection (40 mg) |
|
| Lidocaine 1% | Drug | Anesthesic used in injection |
|
| 19851159 | Background | 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. |
| 14760802 | Background | Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar 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. |
| 25403682 | Background | 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. |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain and Function Scores | VAS | Mean | Standard Deviation | units on a scale |
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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 | 0 | 10 | 0 | 10 | 0 | 10 |
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |