Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

Sponsor
Rush University Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02591953
Collaborator
(none)
22
1
2
42
0.5

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

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

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

  1. Simple Shoulder Test [1 year]

    12 question assessment of shoulder function with yes or no answers

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Responsible Party:
Jeremy A Alland, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT02591953
Other Study ID Numbers:
  • 15101504
First Posted:
Oct 30, 2015
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022

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

1. Primary Outcome
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

[Not Specified]

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
Email jeremy.alland@rushortho.com
Responsible Party:
Jeremy A Alland, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT02591953
Other Study ID Numbers:
  • 15101504
First Posted:
Oct 30, 2015
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022