Other arthrosis Polyarthrosis
Conditions
Interventions
A randomized clinical trial will be conducted to evaluate the efficacy and safety of analgesic peripheral nerve block (periarticular) treatment in patients over 50 years of age with glenohumeral arthr
and the Control Group, which will receive conventional pharmacological treatment combined with physical therapy. Follow-up assessments will be conducted at four time points: pre-procedure (immediately
Sponsors
Hospital Universitário Pedro Ernesto
Hospital Universitário Pedro Ernesto
Eligibility
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients of both sexes; aged over 50 years; with symptomatic glenohumeral osteoarthritis and no improvement after appropriate, standard conventional conservative treatment; indicated for shoulder arthroplasty; and with glenohumeral osteoarthritis grades 1 to 5 according to the Hamada classification
Exclusion criteria
Exclusion criteria: Failure to sign the Informed Consent Form; psychiatric and/or cognitive disorders that preclude assessment and follow-up; coagulopathies or International Normalized Ratio greater than 1.5; history of malignant neoplasm within the last five years; orthobiologic procedures performed in the same joint within the past 6 months; stroke or acute myocardial infarction within the last 3 months; intolerance or allergy to local anesthetics; and participation in other studies within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that, over follow-up (30 days, 3 months, and 6 months), there will be a reduction in pain intensity and a progressive improvement in shoulder function in the intervention group compared with the control group, as verified using the Numeric Rating Scale (NRS, 0–10) and validated functional scores (SPADI and/or ASES) applied at baseline and at each follow-up time point, and the outcomes will be considered achieved when there is a decrease of = 2 points and/or = 30% in NRS compared with baseline and a clinically meaningful improvement in functional scores (e.g., a decrease of = 13 points in SPADI and/or an increase of = 12 points in ASES) compared with baseline, in addition to a favorable between-group difference at the same time point | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the intervention group, compared with the control group, will show improved quality of life, reduced analgesic use (especially opioids), and delayed need for shoulder arthroplasty, as verified using the SF-12 (physical and mental components) administered at baseline and at follow-up time points, a standardized medication-use log (drug class, dose, and frequency; and, when applicable, opioid conversion to morphine milligram equivalents per day – MME/day), and assessment of time to surgery and/or the proportion of participants undergoing arthroplasty during follow-up, and the outcomes will be considered achieved when there is an increase of = 5 points in SF-12 (PCS and/or MCS) from baseline, a = 30% reduction in total analgesic use and/or MME/day, and an increase in median time to surgery and/or a lower proportion of surgeries performed by 6 months in the intervention group compared with the control group | — |
Countries
BR
Contacts
Public ContactAndré Luiz de Pessoa
Hospital Universitário Pedro Ernesto
Outcome results
None listed