Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

Injection Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02591953
• Other study ID #: 15101504
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 2019

Study information

• Verified date: July 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Biceps Tendonitis
• Injection
• Tendinopathy

Intervention

Procedure:
• Ultrasound-guidance
Using ultrasound-guidance to perform a corticosteroid injection
• Landmark-guidance
Using landmark-guidance to perform a corticosteroid injection

Drug:
• Methylprednisolone
Corticosteroid used in injection (40 mg)
• Lidocaine 1%
Anesthesic used in injection

Locations

Country	Name	City	State
United States	Midwest Orthopeadics at Rush	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simple Shoulder Test	12 question assessment of shoulder function with yes or no answers	1 year

External Links

•   AMSSM Statement of Interventional Musculoskeletal Ultrasound