Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review

Abstract

Introduction 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 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). Conclusion A vast array of terms, definition and classification systems were identified. There is no one common definition or classification for adverse events following spinal and peripheral joint manipulation and mobilization. Findings support the urgent need for consensus on the terms, definition and classification system for adverse events related to these interventions.

Reporting of adverse events associated with spinal manipulation in randomised clinical trials: an updated systematic review

“…A recent scoping review explores the complexity of the current literature reporting on adverse events associated with spinal and peripheral joint manipulation and mobilisation. 47 Specifically, the authors report that conflicting opinions regarding facets of adverse event definition and classification such as: symptom severity and duration, relatedness to the intervention (eg, time to onset and treatment provided), action taken to treat the symptoms and expectedness, which profession delivered the intervention and geographical location (with possible medico-legal constraints and/or different expectations of reporting/not reporting), are all factors to reflect on when considering adverse events associated with joint manipulation and mobilisation. In an attempt to address the lack of standardised definitions and classification systems across professions that deliver spinal manipulation, the same authors have conducted an international Delphi study (manuscript in preparation; protocol paper 41 ) to determine, by expert consensus, a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation.…”

“…A recent scoping review explores the complexity of the current literature reporting on adverse events associated with spinal and peripheral joint manipulation and mobilisation 47. Specifically, the authors report that conflicting opinions regarding facets of adverse event definition and classification such as: symptom severity and duration, relatedness to the intervention (eg, time to onset and treatment provided), action taken to treat the symptoms and expectedness, which profession delivered the intervention and geographical location (with possible medico-legal constraints and/or different expectations of reporting/not reporting), are all factors to reflect on when considering adverse events associated with joint manipulation and mobilisation.…”

A retrospective analysis of the incidence of severe adverse events among recipients of chiropractic spinal manipulative therapy

“…Previous large studies have examined AEs occurring in relation to SMT from various professions, including chiropractic 4 , Chuna (traditional Korean manual therapy) 5 , and osteopathy 6 . Studies have estimated that severe AEs such as fractures, cauda equina syndrome, or cervical artery dissection occur between 1 per 2 million to 7 per 100,000 SMT treatments 3 .…”

“…Studies have estimated that severe AEs such as fractures, cauda equina syndrome, or cervical artery dissection occur between 1 per 2 million to 7 per 100,000 SMT treatments 3 . However, there have been several limitations in such studies, such as the use of a variety of customized definitions or grading systems for AEs, making this data challenging to interpret 4 . Some studies have relied on administrative claims data that lacks verification with the medical records 7 , report AEs caused by individuals unqualified to administer SMT 8 , 9 , or do not include patients’ baseline symptoms prior to the AE 10 .…”

“…While various schemes have been used previously to grade the severity of AEs in relation to SMT 4 , the current study utilized the Common Terminology Criteria for Adverse Events (CTCAE). Previous authors have utilized this system to grade the severity of AEs related to SMT 5,[32][33][34] .…”