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 3

Studies providing direct adverse event definition only (n = 19).

Author, year, citation Study Design Definition
Senstad et al. 1997 [57] Survey Any unpleasant reaction after the previous treatment
Malone et al. 2002 [58] Case Report / series A detrimental result of the treatment:
Reaction is a slight or clinically insignificant short-lived symptom
Incident (or irreversible complication) is an unexpected event resulting in serious impairment, injury, or fatality
Hurwitz et al. 2005 [59] Trial Unpleasant reactions they may have had as a result of chiropractic treatment
Rajendran et al. 2009 [31] Survey Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of an intervention (treatment), which does not necessarily have a causal relationship with such treatment
Kuczynski et al. 2012 [60] Review Unintended consequences of treatment
Puentedura et al. 2012 [61] Review The sequelae following a cervical spine manipulation that are medium to long term in duration, with moderate to severe symptoms, and of a nature that was serious, distressing, and unacceptable to the patient and required further treatment
Bjorklund et al. 2012 [62] Protocol “Much worse” or “Very much worse” on the Patient Global Impression of Change Scale
Reid et al. 2014 [63] Trial Any new symptoms after the interventions and if the symptoms persisted for more than 24 hours
MacPherson et al. 2015 [64] Survey Reactions to treatment that they found unexpected or unpleasant
Rajendran et al. 2015 [65] Survey Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of an intervention (treatment), which does not necessarily have a causal relationship with such treatment.
Puentedura et al. 2015 [66] Review The sequelae following thrust joint manipulation to the spine that are medium to long term in duration, with moderate to severe symptoms, and of a nature that is serious, distressing and unacceptable to the patient and requires further treatment
Unwanted side effect: short term, mild in nature, non-serious, transient and reversible consequences of the treatment
Petrozzi et al. 2015 [67] Protocol A new related complaint which was not present at baseline or previous visit, or a worsening of the presenting complaint
Bussieres et al. 2016 [68] Clinical Practice guideline Medical occurrence temporally associated with the use of a treatment or a medicinal product, but not necessarily causally related.
Undesirable outcomes
Kranenburg et al. 2017 [33] Consensus Adverse events are unexpected events that occur following an intervention without evidence of causality
Kranenburg et al. 2017 [69] Review The sequelae following a cervical spinal manipulation that are medium to long term in duration, with moderate to severe symptoms, and of a nature that was serious, distressing, and unacceptable to the patient and required further treatment.
Side effects are defined as short term, mild in nature, nonserious, transient and reversible consequences of the treatment.
Heneghan et al. 2018 [70] Survey Side-effects are reversible, often transient in nature and are a recognized sequelae of thoracic joint manipulation
Concerning adverse events: there is the potential for life changing consequences
Coulter et al. 2018 [71] Review Any adverse experience during treatment resulting in death, life-threatening adverse experience, hospitalization or prolongation of existing hospitalization, or persistent or significant disability or incapacity’
Funabashi et al. 2020 [72] Survey An unintended response to treatment that may or may not be caused by the treatment
Heneghan et al. 2020 [34] Review An ‘untoward medical occurrence’ in a patient subjected to an intervention
Side effects are minor, reversible and short lived
Adverse events are moderate to severe, last longer and importantly may require medical management

Author, year, citation	Study Design	Definition
Senstad et al. 1997 [57]	Survey	Any unpleasant reaction after the previous treatment
Malone et al. 2002 [58]	Case Report / series	A detrimental result of the treatment:
		Reaction is a slight or clinically insignificant short-lived symptom
		Incident (or irreversible complication) is an unexpected event resulting in serious impairment, injury, or fatality
Hurwitz et al. 2005 [59]	Trial	Unpleasant reactions they may have had as a result of chiropractic treatment
Rajendran et al. 2009 [31]	Survey	Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of an intervention (treatment), which does not necessarily have a causal relationship with such treatment
Kuczynski et al. 2012 [60]	Review	Unintended consequences of treatment
Puentedura et al. 2012 [61]	Review	The sequelae following a cervical spine manipulation that are medium to long term in duration, with moderate to severe symptoms, and of a nature that was serious, distressing, and unacceptable to the patient and required further treatment
Bjorklund et al. 2012 [62]	Protocol	“Much worse” or “Very much worse” on the Patient Global Impression of Change Scale
Reid et al. 2014 [63]	Trial	Any new symptoms after the interventions and if the symptoms persisted for more than 24 hours
MacPherson et al. 2015 [64]	Survey	Reactions to treatment that they found unexpected or unpleasant
Rajendran et al. 2015 [65]	Survey	Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of an intervention (treatment), which does not necessarily have a causal relationship with such treatment.
Puentedura et al. 2015 [66]	Review	The sequelae following thrust joint manipulation to the spine that are medium to long term in duration, with moderate to severe symptoms, and of a nature that is serious, distressing and unacceptable to the patient and requires further treatment
Puentedura et al. 2015 [66]	Review	Unwanted side effect: short term, mild in nature, non-serious, transient and reversible consequences of the treatment
Petrozzi et al. 2015 [67]	Protocol	A new related complaint which was not present at baseline or previous visit, or a worsening of the presenting complaint
Bussieres et al. 2016 [68]	Clinical Practice guideline	Medical occurrence temporally associated with the use of a treatment or a medicinal product, but not necessarily causally related.
Bussieres et al. 2016 [68]	Clinical Practice guideline	Undesirable outcomes
Kranenburg et al. 2017 [33]	Consensus	Adverse events are unexpected events that occur following an intervention without evidence of causality
Kranenburg et al. 2017 [69]	Review	The sequelae following a cervical spinal manipulation that are medium to long term in duration, with moderate to severe symptoms, and of a nature that was serious, distressing, and unacceptable to the patient and required further treatment.
Kranenburg et al. 2017 [69]	Review	Side effects are defined as short term, mild in nature, nonserious, transient and reversible consequences of the treatment.
Heneghan et al. 2018 [70]	Survey	Side-effects are reversible, often transient in nature and are a recognized sequelae of thoracic joint manipulation
Heneghan et al. 2018 [70]	Survey	Concerning adverse events: there is the potential for life changing consequences
Coulter et al. 2018 [71]	Review	Any adverse experience during treatment resulting in death, life-threatening adverse experience, hospitalization or prolongation of existing hospitalization, or persistent or significant disability or incapacity’
Funabashi et al. 2020 [72]	Survey	An unintended response to treatment that may or may not be caused by the treatment
Heneghan et al. 2020 [34]	Review	An ‘untoward medical occurrence’ in a patient subjected to an intervention
		Side effects are minor, reversible and short lived
		Adverse events are moderate to severe, last longer and importantly may require medical management