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

Martha Funabashi; Lindsay M. Gorrell; Katherine A. Pohlman; Andrea Bergna; Nicola R. Heneghan

doi:10.1371/journal.pone.0270671

Table 7

Studies providing indirect adverse event classification system only (n = 10).

Authors, year, citation Study design Classification system
Barrett et al. 2000 [100] Survey “Hardly any discomfort, mild discomfort, moderate discomfort, severe discomfort, worst possible discomfort—one hour, one day and two days after SMT’’
Meeker et al. 2002 [101] Review “. . . onset within 4 hours of the procedure, disappearing within 24 hours’’; ’’Serious complication cases including fatalities, major impairments’’
Mentions severe, serious
Anderson-Peacock et al. 2005 [102] Clinical Practice Guideline Non-treatment adverse events–not associated with a treatment modality, but that occur in the clinical setting;
Unforseen-treatment adverse events–associated with a treatment modality, but not a known or observable risk factor;
Forseen-treatment adverse events–associated with a treatment modality and predicted by an observable risk factor
Cleland et al. 2007 [97] Trial “Subjects. . . were asked to report the time of onset (categorized as ≤24 hours or >24 hours), the duration (categorized as ≤24 hours or >24 hours), and the severity (scored on a scale of 1–4, where 1 = light to 4 = severe) of the symptoms’’; Mentions mild, moderate, serious
Dagenais et al. 2010 [103] Review Minor, temporary, self-limiting (side-effects)
serious; last between several hours and a few days
Carlesso et al. 2010 [104] Review “The adverse events were initially grouped into major—death, stroke or permanent neurological deficits and minor—transient neurological symptoms, increased neck pain/stiffness, headache, radiating pain, fatigue or other’’
Yin et al. 2014 [105] Review Mild, minor, moderate, medium, serious; appeared within 4–24 hours of treatment; disappeared within 24 hours; rated ≤ NRS regarding severity
Coulter et al. 2019 [106] Review Minor; typically transient
Funabashi et al. 2020 [107] Survey Variation in terms of frequency and severity, ranging from the more frequent minor/benign adverse events to rare and serious adverse events
Zhang et al. 2021 [108] Protocol “Shedding criteria: 1) intolerable adverse reactions; 2) serious adverse reactions; 3) the patients’ pain continued to increase, which proved that trial participation was not suitable; 4) the patient’s health may be damaged (for example, serious complications)’’

NRS: numeric rating scale;
SMT = spinal manipulative therapy.

Authors, year, citation	Study design	Classification system
Barrett et al. 2000 [100]	Survey	“Hardly any discomfort, mild discomfort, moderate discomfort, severe discomfort, worst possible discomfort—one hour, one day and two days after SMT’’
Meeker et al. 2002 [101]	Review	“. . . onset within 4 hours of the procedure, disappearing within 24 hours’’; ’’Serious complication cases including fatalities, major impairments’’
Meeker et al. 2002 [101]	Review	Mentions severe, serious
Anderson-Peacock et al. 2005 [102]	Clinical Practice Guideline	Non-treatment adverse events–not associated with a treatment modality, but that occur in the clinical setting;
		Unforseen-treatment adverse events–associated with a treatment modality, but not a known or observable risk factor;
		Forseen-treatment adverse events–associated with a treatment modality and predicted by an observable risk factor
Cleland et al. 2007 [97]	Trial	“Subjects. . . were asked to report the time of onset (categorized as ≤24 hours or >24 hours), the duration (categorized as ≤24 hours or >24 hours), and the severity (scored on a scale of 1–4, where 1 = light to 4 = severe) of the symptoms’’; Mentions mild, moderate, serious
Dagenais et al. 2010 [103]	Review	Minor, temporary, self-limiting (side-effects)
Dagenais et al. 2010 [103]	Review	serious; last between several hours and a few days
Carlesso et al. 2010 [104]	Review	“The adverse events were initially grouped into major—death, stroke or permanent neurological deficits and minor—transient neurological symptoms, increased neck pain/stiffness, headache, radiating pain, fatigue or other’’
Yin et al. 2014 [105]	Review	Mild, minor, moderate, medium, serious; appeared within 4–24 hours of treatment; disappeared within 24 hours; rated ≤ NRS regarding severity
Coulter et al. 2019 [106]	Review	Minor; typically transient
Funabashi et al. 2020 [107]	Survey	Variation in terms of frequency and severity, ranging from the more frequent minor/benign adverse events to rare and serious adverse events
Zhang et al. 2021 [108]	Protocol	“Shedding criteria: 1) intolerable adverse reactions; 2) serious adverse reactions; 3) the patients’ pain continued to increase, which proved that trial participation was not suitable; 4) the patient’s health may be damaged (for example, serious complications)’’