Corticosteroid Injection Versus Nerve Block
A Randomized Comparative Cohort Study of the Use of Intra-articular Corticosteroid Injection Compared to Suprascapular Nerve Block for Treatment of Shoulder Pain
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Allison Rao
- Phone Number: 608-445-0545
- Email: rao00149@umn.edu
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- Recruiting
- University of Minnesota
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Contact:
- Allison Rao
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosis of glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff arthropathy who are being offered injection
Exclusion Criteria:
- uncontrolled diabetes (patients will be excluded if no HbA1c within a year or if it is 8 or greater"
- known allergy to steroid or anesthetic
- pregnant women
- prisoners
- patients with diminished capacity to consent to participation
- children under 18 years of age
- non-English speakers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: intraarticular methylprednisolone acetate injection (IACI)
Patients with glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff arthropathy who are poor surgical candidates or who are not interested in pursuing surgery randomized to intraarticular corticosteroid injection (IACI).
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The patient will be in a seated position.
Correct patient, laterality, and procedure will be performed during the timeout.
Ultrasound guidance will be used to identify the glenohumeral joint.
The injection site will then be disinfected with an alcohol wipe.
A 21, 22, or 23-gauge needle (depending on provider preference) will be advanced into the glenohumeral joint under direct ultrasound visualization.
After entry into the glenohumeral joint, a negative aspiration will be performed.
At that time, up to 1 mL of 40mg/mL methylprednisolone acetate will be injected be injected into the joint space.
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Experimental: suprascapular nerve block (SSNB) with bupivacaine and triamcinolone
Patients with glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff arthropathy who are poor surgical candidates or who are not interested in pursuing surgery randomized to suprascapular nerve block (SSNB)
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The patient will be in a seated position.
Correct patient, laterality, and procedure will be performed during the timeout.
Ultrasound guidance will be used to identify the suprascapular nerve in its path at the suprascapular notch.
After disinfection of the injection site with alcohol, anatomic landmarks for SSNB as described by Dangoisse et al. [10] will be marked with a marking pen.
Ultrasound will be utilized to guide the tip of a 21, 22, or 23 gauge (depending on provider preference) needle to the floor of the suprascapular fossa while avoiding neurovascular structures.
At that time, a mixture of up to 10 mL of 0.5% bupivacaine and 20 mg triamcinolone will be slowly injected to fill the fascial contents of the suprascapular fossa under direct ultrasound guidance.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in visual analog scale (VAS) for pain
Time Frame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
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a validated continuous scale assessment for pain
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preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
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single assessment numerical evaluation (SANE) of the shoulder
Time Frame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
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a validated tool providing a numerical score from 0-100 that assess shoulder function as subjectively reported by the subject.
A higher score indicates superior shoulder function.
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preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
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Oxford shoulder score (OSS)
Time Frame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
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a validated patient-reported outcome measure used to assess shoulder pain and functional disability.
Possible scores range from 0-48 with higher scores indicating superior better shoulder function.
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preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
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American shoulder and elbow surgeons (ASES) score
Time Frame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
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a validated survey with possible scores from 0-100 that assesses shoulder function as reported by the subject.
A higher score indicates superior shoulder function.
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preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Allison Rao, MD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ORTHOSURG-2024-33106
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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