Corticosteroid Injection Versus Nerve Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff arthropathy who are being offered injection
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
intraarticular corticosteroid injection (IACI)
Other interventionThe 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.
suprascapular nerve block (SSNB)
Other interventionThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: intraarticular methylprednisolone acetate injection (IACI)Experimental treatment 1 intervention
Group B: suprascapular nerve block (SSNB) with bupivacaine and triamcinoloneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
change in visual analog scale (VAS) for pain
a validated continuous scale assessment for pain
Time frame
preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention2
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.
Time frame
preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention3
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.
Time frame
preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention4
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.
Time frame
preintervention, 24 hours, 3 days, 1 month, and 3 months postinterventionSponsors and contacts
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Source ClinicalTrials.gov