Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review
Martha Funabashi 1 , Lindsay M. Gorrell 2, Katherine A. Pohlman 3, Andrea Bergna 4, Nicola R. Heneghan 5
1Division of Research and Innovation, Canadian Memorial Chiropractic College, Toronto, ON, Canada, Department of Chiropractic, Université du Québec à Trois-Rivières, Trois-Rivières, QC, Canada 2Department of Chiropractic Medicine, Integrative Spinal Research Group, University of Zürich and University Hospital Balgrist, Zürich, Switzerland 3Research Center, Parker University, Dallas, TX, United States of America 4Research Department, SOMA Istituto Osteopatia Milano, Milan, Italy, AISO-Associazione Italiana Scuole di Osteopatia, Pescara, Italy 5School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom
Introduction and hypothesis: Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are many reports of adverse events (or undesirable outcomes) following such interventions, there is no common definition for an adverse event or clarity on any severity classification. This impedes advances of patient safety initiatives and practice. This scoping review mapped the evidence of adverse event definitions and classification systems following spinal and peripheral joint manipulation and mobilization for musculoskeletal conditions in adults.
Methods: An electronic search of the following databases was performed from inception to February 2021: MEDLINE, EMBASE, CINAHL, Scopus, AMED, ICL, PEDro, Cochrane Library, Open Grey and Open Theses and Dissertations. Studies including adults (18 to 65 years old) with a musculoskeletal condition receiving spinal or peripheral joint manipulation or mobilization and providing an adverse event definition and/or classification were included. All study designs of peer-reviewed publications were considered. Data from included studies were charted using a standardized data extraction form and synthesised using narrative analysis.
Results: Seven articles were included in the review, five of these in the meta-analysis. None of these studies were completely judged at low RoB. MMT was revealed to be not significantly superior for pain reduction [ES: -0.54 (-1.16; 0.08); p = 0.09], for symptom impact [ES: -0.37 (-0.87; 0.13); p = 0.15], and for quality of life [ES: -0.44 (-1.22, 0.33), p = 0.26] compared to standard care. The quality of evidence was “very low”. Other results were presented in a qualitative synthesis.
Conclusions: From 8248 identified studies, 98 were included in the final synthesis. A direct definition for an adverse event and/or classification system was provided in 69 studies, while 29 provided an indirect definition and/or classification system. The most common descriptors to define an adverse event were causality, symptom severity, onset and duration. Twenty-three studies that provided a classification system described only the end anchors (e.g., mild/minor and/or serious) of the classification while 26 described multiple categories (e.g., moderate, severe).