Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections
Primary Purpose
Biceps Tendonitis, Injection
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-guidance
Landmark-guidance
Methylprednisolone
Lidocaine 1%
Sponsored by
About this trial
This is an interventional treatment trial for Biceps Tendonitis
Eligibility 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
Sites / Locations
- Midwest Orthopeadics at Rush
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound-guided Injection
Landmark-guided Injection
Arm Description
Injection performed with ultrasound-guidance
Injection performed at point of maximal tenderness along biceps tendon
Outcomes
Primary Outcome Measures
Simple Shoulder Test
12 question assessment of shoulder function with yes or no answers
Secondary Outcome Measures
Full Information
NCT ID
NCT02591953
First Posted
October 21, 2015
Last Updated
July 14, 2022
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02591953
Brief Title
Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet enrollment and follow up criteria
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biceps Tendonitis, Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound-guided Injection
Arm Type
Experimental
Arm Description
Injection performed with ultrasound-guidance
Arm Title
Landmark-guided Injection
Arm Type
Active Comparator
Arm Description
Injection performed at point of maximal tenderness along biceps tendon
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guidance
Intervention Description
Using ultrasound-guidance to perform a corticosteroid injection
Intervention Type
Procedure
Intervention Name(s)
Landmark-guidance
Intervention Description
Using landmark-guidance to perform a corticosteroid injection
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Corticosteroid used in injection (40 mg)
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1%
Intervention Description
Anesthesic used in injection
Primary Outcome Measure Information:
Title
Simple Shoulder Test
Description
12 question assessment of shoulder function with yes or no answers
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Midwest Orthopeadics at Rush
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21782470
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.
Results Reference
background
PubMed Identifier
21458143
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.
Results Reference
background
PubMed Identifier
19851159
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.
Results Reference
background
PubMed Identifier
14760802
Citation
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.
Results Reference
background
PubMed Identifier
25403682
Citation
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.
Results Reference
background
Links:
URL
http://journals.lww.com/cjsportsmed/Fulltext/2015/01000/American_Medical_Society_for_Sports_Medicine.2.aspx
Description
AMSSM Statement of Interventional Musculoskeletal Ultrasound
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Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections
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