Apr 16, 2025
Version 2
Rediscovering Intramuscular Glucocorticoids: A Forgotten Strategy in Rheumatology? V.2
- 1Rheumatology Unit, Department of Medicine-DIMED, University of Padova, Italy
Protocol Citation: Gianluca Poncina 2025. Rediscovering Intramuscular Glucocorticoids: A Forgotten Strategy in Rheumatology?. protocols.io https://dx.doi.org/10.17504/protocols.io.bp2l68bjkgqe/v2Version created by Gianluca Poncina
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: In development
We are still developing and optimizing this protocol
Created: April 14, 2025
Last Modified: April 16, 2025
Protocol Integer ID: 126780
Keywords: Rheumatoid arthritis, intramuscular glucocorticoid, methylprednisolone
Disclaimer
DISCLAIMER – FOR INFORMATIONAL PURPOSES ONLY; USE AT YOUR OWN RISK
The protocol content here is for informational purposes only and does not constitute legal, medical, clinical, or safety advice, or otherwise; content added to protocols.io is not peer reviewed and may not have undergone a formal approval of any kind. Information presented in this protocol should not substitute for independent professional judgment, advice, diagnosis, or treatment. Any action you take or refrain from taking using or relying upon the information presented here is strictly at your own risk. You agree that neither the Company nor any of the authors, contributors, administrators, or anyone else associated with protocols.io, can be held responsible for your use of the information contained in or linked to this protocol or any of our Sites/Apps and Services.
Abstract
This scoping review protocol aims to systematically map the available evidence on the use of intramuscular glucocorticoids (IM-GCs) in the management of rheumatoid arthritis, with a particular focus on repeated administration regimens (e.g., methylprednisolone 120 mg or triamcinolone 80 mg administered 1–4 times yearly). The review will follow PRISMA-ScR guidelines and include a comprehensive search of major biomedical databases, incorporating both interventional and observational studies as well as clinical guidelines.
The expected findings will clarify the clinical indications, effectiveness, and safety profile of IM-GCs in RA, addressing a key research question identified by the 2022 EULAR recommendations. This synthesis will support evidence-informed practice and guide future studies on the positioning of depot glucocorticoids in rheumatology.
ADMINISTRATIVE INFORMATION
ADMINISTRATIVE INFORMATION
Title: Rediscovering Intramuscular Glucocorticoids: A Forgotten Strategy in Rheumatology?
Registration: This scoping review protocol follows the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines. The protocol is registered and publicly available on protocols.io at: [inserire link definitivo una volta disponibile].
Authors: Dr. Gianluca Poncina et al.
Amendments: Any important amendments to this protocol will be documented on protocols.io with a description, rationale, and date of change.
Support: No specific funding. Institutional support from the University of Padova – U.O.C. Reumatologia.
INTRODUCTION
INTRODUCTION
Rationale: Despite historical use of intramuscular glucocorticoids (IM-GC) in RA, their role has become marginal in contemporary practice. EULAR guidelines highlight the need to investigate their effectiveness and safety, particularly in repeated administrations. This review aims to map the literature on IM-GC use in RA and other rheumatic diseases.
Objectives: To explore and map the available evidence on the effectiveness and safety of repeated intramuscular glucocorticoids in patients with RA, focusing on regimens such as methylprednisolone 125 mg or triamcinolone 80 mg administered 1–4 times per year.
METHODS
METHODS
Eligibility Criteria: Inclusion criteria: - Adults with rheumatoid arthritis - Studies on IM-GC (e.g., methylprednisolone, triamcinolone) - Any study design (RCTs, observational, reviews, guidelines) - Outcomes on effectiveness or safety Exclusion criteria: - Non-rheumatic indications - Non-intramuscular glucocorticoids (unless comparison included) - Preclinical or animal studies - Conference abstracts without full text
Information Sources Databases to be searched: - PubMed/MEDLINE - Embase - Scopus - Web of Science - Cochrane Library - ClinicalTrials.gov
Search Strategy: Draft search strategy will include terms for 'glucocorticoids', 'intramuscular', and rheumatic diseases. The final strategy will be adapted to each database and reported in full as supplementary material.
Study Records Data management: References will be managed using Paperpile. Deduplication of the records will be performed using the same software.
Selection process: Two reviewers will independently screen titles, abstracts, and full-texts.
Data collection process: Data will be charted using a standardized, ad hoc form developed in Google Sheets, based on consensus among the reviewers. The form includes the following data items: author(s), year of publication, country of origin, study aims/purpose, population and sample size, methodology/methods, type and dose of intramuscular glucocorticoid, frequency of administration, outcomes (including measurement tools), and key findings relevant to the scoping review questions. A calibration exercise was conducted on a sample of five studies, and data extraction was performed independently by two reviewers. Discrepancies were resolved through discussion and, when needed, adjudicated by a third reviewer, who also performed final quality control.
Data Items: Study design, population, IM-GC type and dose, administration frequency, outcomes (effectiveness and safety), key findings.
Outcomes and Prioritization: Primary outcomes include disease activity control, flare prevention, patient-reported outcomes, and safety profile (AEs, metabolic effects).
Risk of Bias in Individual Studies Although formal exclusion based on quality was not planned, a critical appraisal of individual sources of evidence was conducted using the Joanna Briggs Institute (JBI) Critical Appraisal Checklists, with tools selected according to study design. The goal was to enhance interpretation of the findings. Appraisals were independently conducted by two reviewers, with discrepancies resolved by consensus. The results of the appraisal were used to inform the narrative synthesis, without excluding studies.
Data Synthesis: Data will be synthesized using a narrative approach, organized around emerging thematic domains such as disease indication, type and regimen of IM-GC used, clinical setting, and reported outcomes (e.g., disease activity, patient-reported outcomes, safety). Summary tables will be developed to report study characteristics and main findings. Where relevant, visual representations such as conceptual maps or matrices may be included to illustrate trends and knowledge gaps.
Meta-bias(es): Not applicable to scoping reviews.
Confidence in Cumulative Evidence: Not applicable to scoping reviews.