Corticosteroid Injection Versus Nerve Block

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06735027
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Minnesota
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Allison Rao, MD
Principal Investigator Affiliation	University of Minnesota
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glenohumeral Arthritis, Rotator Cuff Arthropathy

Arms & Interventions

Arms

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).

Experimental: suprascapular nerve block (SSNB) with bupivacaine and triamcinolone

Interventions

Other: - 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.

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55414

Site Contact

Allison Rao

[email protected]

608-445-0545

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