Corticosteroid Injection Versus Nerve Block

NCT06735027 | Recruiting

• 1 other identifier: ORTHOSURG-2024-33106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Arthropathy; Glenohumeral Arthritis

Keywords

osteoarthritis; glenohumeral arthritis; rotator cuff arthropathy; corticosteroid injection; suprascapular nerve block

Outcome Measures

Primary Outcomes (4)

• change in visual analog scale (VAS) for pain

  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

  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)

  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

  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

Study Arms (2)

intraarticular methylprednisolone acetate injection (IACI)

EXPERIMENTAL

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).

Other: intraarticular corticosteroid injection (IACI)

suprascapular nerve block (SSNB) with bupivacaine and triamcinolone

EXPERIMENTAL

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)

Other: suprascapular nerve block (SSNB)

Interventions

suprascapular nerve block (SSNB) OTHER

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.

suprascapular nerve block (SSNB) with bupivacaine and triamcinolone

intraarticular corticosteroid injection (IACI) OTHER

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.

intraarticular methylprednisolone acetate injection (IACI)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff arthropathy who are being offered injection

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Allison Rao, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Rao

CONTACT

608-445-0545; rao00149@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two study arms, with each arm receiving one of two interventions: corticosteroid shoulder injection or suprascapular nerve block

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 16, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)