NCT02591953

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 18, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

3.5 years

First QC Date

October 21, 2015

Results QC Date

May 25, 2021

Last Update Submit

July 14, 2022

Conditions

Biceps TendonitisInjection

Outcome Measures

Primary Outcomes (1)

  • Simple Shoulder Test

    12 question assessment of shoulder function with yes or no answers

    1 year

Study Arms (2)

Ultrasound-guided Injection

EXPERIMENTAL

Injection performed with ultrasound-guidance

Procedure: Ultrasound-guidanceDrug: MethylprednisoloneDrug: Lidocaine 1%

Landmark-guided Injection

ACTIVE COMPARATOR

Injection performed at point of maximal tenderness along biceps tendon

Procedure: Landmark-guidanceDrug: MethylprednisoloneDrug: Lidocaine 1%

Interventions

Ultrasound-guidancePROCEDURE

Using ultrasound-guidance to perform a corticosteroid injection

Ultrasound-guided Injection
Landmark-guidancePROCEDURE

Using landmark-guidance to perform a corticosteroid injection

Landmark-guided Injection
MethylprednisoloneDRUG

Corticosteroid used in injection (40 mg)

Landmark-guided InjectionUltrasound-guided Injection
Lidocaine 1%DRUG

Anesthesic used in injection

Landmark-guided InjectionUltrasound-guided Injection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior biceps surgery or injections
  • Prior SLAP or labral repair
  • Concomitant shoulder arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwest Orthopeadics at Rush

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

  • 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.

    PMID: 21782470BACKGROUND

  • 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.

    PMID: 21458143BACKGROUND

  • 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.

    PMID: 19851159BACKGROUND

  • 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.

    PMID: 14760802BACKGROUND

  • 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.

    PMID: 25403682BACKGROUND

Related Links

MeSH Terms

Interventions

MethylprednisoloneLidocaine

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Jeremy Alland
Organization
Rush
jeremy.alland@rushortho.com
3124322434

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 30, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

July 18, 2022

Results First Posted

July 18, 2022

Record last verified: 2022-07

Locations

US(1)