- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06735027
Corticosteroid Injection Versus Nerve Block
January 5, 2026 updated by: University of Minnesota
A Randomized Comparative Cohort Study of the Use of Intra-articular Corticosteroid Injection Compared to Suprascapular Nerve Block for Treatment of Shoulder Pain
The purpose of this study is to evaluate conservative pain relief measures for patients suffering from glenohumeral arthritis or rotator cuff arthropathy.
Conservative management of osteoarthritis is often first line treatment, and while a corticosteroid injection is frequently used, suprascapular nerve blocks have not often been described as an analgesic option in this population.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Allison Rao
- Phone Number: 608-445-0545
- Email: rao00149@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- Recruiting
- University of Minnesota
-
Contact:
- Allison Rao
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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).
|
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.
|
|
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)
|
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.
|
What is the study measuring?
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
|
a validated continuous scale assessment for pain
|
preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
|
single assessment numerical evaluation (SANE) of the shoulder
Time Frame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
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.
|
preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
|
Oxford shoulder score (OSS)
Time Frame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
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.
|
preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
|
American shoulder and elbow surgeons (ASES) score
Time Frame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
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.
|
preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Allison Rao, MD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2025
Primary Completion (Estimated)
January 2, 2027
Study Completion (Estimated)
January 2, 2027
Study Registration Dates
First Submitted
December 3, 2024
First Submitted That Met QC Criteria
December 10, 2024
First Posted (Actual)
December 16, 2024
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTHOSURG-2024-33106
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.