Pediatrics. 2007 (Jan); 119 (1): e275–e283 ~ FULL TEXT
Sunita Vohra, MD, FRCPC, MSc, Bradley C. Johnston, ND, Kristie Cramer, MSc, Kim Humphreys, DC, PhD
Department of Pediatrics,
University of Alberta,
Edmonton, Alberta, Canada T6G 2E1.
FCER and ICPA's Response to this article
BACKGROUND: Spinal manipulation is a noninvasive manual procedure applied to specific body tissues with therapeutic intent. Although spinal manipulation is commonly used in children, there is limited understanding of the pediatric risk estimates.
OBJECTIVE: Our goal was to systematically identify and synthesize available data on adverse events associated with pediatric spinal manipulation.
METHODS: A comprehensive search was performed of 8 major electronic databases (eg, Medline, AMED, MANTIS) from inception to June 2004 irrespective of language. Reports were included if they (1) were a primary investigation of spinal manipulation (eg, observation studies, controlled trials, surveys), (2) included a study population of children who were aged 18 years or younger, and (3) reported data on adverse events. Data were summarized to demonstrate the nature and severity of adverse events that may result rather than their incidence.
RESULTS: Thirteen studies (2 randomized trials, 11 observational reports) were identified for inclusion. We identified 14 cases of direct adverse events involving neurologic or musculoskeletal events. Nine cases involved serious adverse events (eg, subarachnoidal hemorrhage, paraplegia), 2 involved moderately adverse events that required medical attention (eg, severe headache), and 3 involved minor adverse events (eg, midback soreness). Another 20 cases of indirect adverse events involved delayed diagnosis (eg, diabetes, neuroblastoma) and/or inappropriate provision of spinal manipulation for serious medical conditions (ie, meningitis, rhabdomyosarcoma).
CONCLUSIONS: Serious adverse events may be associated with pediatric spinal manipulation; neither causation nor incidence rates can be inferred from observational data. Conduct of a prospective population-based active surveillance study is required to properly assess the possibility of rare, yet serious, adverse events as a result of spinal manipulation on pediatric patients.
Key Words spinal manipulation, pediatric, adverse events
From the FULL TEXT Article:
Spinal manipulation is a noninvasive manual procedure
applied to specific body tissues with therapeutic
intent. A variety of different care providers (eg,
physiotherapists, massage therapists, physicians, osteopaths,
naturopaths) may perform manipulation as part
of their practice, but it is most frequently performed by
chiropractors.  The procedure is delivered by hand and
can vary in velocity, amplitude, duration, frequency,
location on the body, and direction of force. According
to the American Chiropractic Association, chiropractic
procedures specifically include the adjustment and manipulation
of the articulations and adjacent tissues of the
human body, particularly of the spinal column.  Spinal
manipulation, the mainstay of chiropractic care, “emphasizes
the inherent recuperative power of the body to
heal itself without the use of drugs or surgery.” 
Chiropractic medicine is the most common complementary
and alternative medicine (CAM) practice used
by children. [4, 5] Children made an estimated 30 million
visits to US chiropractors in 1997.  In Canada, a recent
survey of 1,804 participants in a university hospital pediatric
emergency department in Toronto, Ontario, indicated
that 31% of children sought chiropractic care. 
In addition, a cross-sectional survey of a random sample
of 140 Canadian chiropractors (57% response rate) revealed
that all the respondents also treated children
(0–18 years old), and 13% of all visits over the preceding
month involved children and youth.  Although, chiropractors
are trained to treat neuromuscular problems
that stem from a mechanical disability within the
body,  children have been found to visit chiropractors for
a variety of reasons including health promotion, musculoskeletal
problems, asthma, otitis media, allergies, infantile
colic, tonsillitis, attention-deficit/hyperactivity
disorder, and enuresis. [6, 9–14]
Spinal manipulation has been suggested as a potential
cause of cerebrovascular accidents (eg, stroke) through
mechanical injury to the vertebral artery. In adults, concerns
regarding serious adverse events related to spinal
manipulation have led to a series of studies examining
risk. [15–17] For example, a review of the literature on complications
of spinal manipulation, which evaluated case
reports, surveys, and review articles, identified 295 complications,
yielding estimates of vertebrobasilar accidents
from 1 in 20,000 patients to 1 per 1 million cervical
manipulations, and cauda equina syndrome to be <1 per
1 million treatments. [17–19] Data from 4 prospective investigations
of 2058 adults who received chiropractic spinal
manipulation indicated that 30% to 55% reported a
minor adverse event (eg, local discomfort, additional
pain, stiffness, headache, fatigue, fainting). [20–23]
Despite the fact that spinal manipulation is widely
used on children, pediatric safety data are virtually nonexistent.
Consequently, some pediatricians believe that
the use of spinal manipulation on children is dangerous
and advise against its use, [24–26] whereas other health care
practitioners and many parents continue with this practice.
There is an urgent need to quantify the risk associated
with spinal manipulation in children.
A comprehensive search was developed by a clinical
librarian in collaboration with content experts to identify
all relevant reports regardless of publication status.
The following electronic databases were searched: Central
(second quarter, 2004), Medline (1966–2004),
PubMed (1966–2004), Embase (1988–2004), CINAHL
(1982–2004), AltHealthWatch (1990–2004), MANTIS
(1900–2005), and ICL (1985–2004) from inception to
June 2004 irrespective of language. For a copy of our
search strategy, please contact the corresponding author.
The primary authors of relevant articles and experts in
the area of spinal manipulation were contacted for information
on additional studies. In addition, reference
lists of relevant articles were examined.
Two reviewers (Dr Johnston and Ashish Mahajan, BSc)
independently reviewed the titles and abstracts (where
available) of all articles generated from the electronic
and grayliterature search. The full manuscripts of reports
relevant to adverse events associated with spinal-manipulation
criteria were retrieved. Independent reviewers
(Dr Johnston, Ms Cramer, and Denise Adams, BSc) assessed
the full articles of each potentially relevant study
by applying the following predetermined set of eligibility
(1) the study was a primary investigation/report
(ie, case reports, case series, case control,
randomized, controlled trials, and survey or surveillance studies);
(2) part or all of the study population was 18 years or
(3) adverse events were reported.
searched for adverse events related to delivery of spinal
manipulation (eg, pain, weakness, disability), and noted
adverse events related to delayed or missed diagnoses
when they were described. Inclusion was not limited by
the condition studied, provider of the spinal-manipulation
intervention (eg, chiropractor, osteopath, physiotherapist,
physician), or the comparison intervention.
Independent reviewers (Dr Johnston, Ms Cramer, and
Denise Adams, BSc) used a structured data-extraction
form to independently extract data. The key data extracted
were type of publication/report (eg, case report,
randomized, controlled trial), participant characteristics
(eg, age and gender), previous medical diagnosis/diagnoses,
type of manipulation (eg, light fingertip pressure,
mobilization, flexion, rotation, high-velocity/low-amplitude),
location of manipulation (eg, cervical), schedule
of manipulation, outcome, and timing of the adverse
event in relation to therapy. Any discrepancies between
reviewers were discussed and resolved by referring to
the original report and, if necessary, consultation with a
Adverse events were classified by using the following
categories: severe (indicating hospitalization, permanent
disability, mortality), moderate (transient disability, involving
seeking medical care but not hospitalization),
minor (self-limited, did not require additional medical
care), and delayed diagnosis or treatment (moderate to
severe adverse event [as defined above] not directly
related to the administration of a spinal manipulation
but as a result of delayed diagnosis or treatment of a medical
condition [eg, meningitis]). Adverse events were tabulated
by using descriptive statistics. A priori, we planned
to summarize adverse events derived from randomized,
controlled trials using risk differences (with corresponding
95% confidence intervals) because events were considered
rare; we planned to summarize data (and conduct
subgroup analyses if possible) according to severity
and type of adverse event, timing of the adverse event,
age group (birth to 5 years, 6–13 years, 14–18 years),
type and schedule of manipulation, location of manipulation,
and type of practitioner.
Electronic database searches identified a total of 13,916
articles for consideration. After screening, 164 potentially
relevant articles were identified for full review. An
additional 68 potentially relevant articles were identified
from review of the reference lists and by contacting
authors of included reports and experts in field. Thirteen
studies met inclusion criteria (10 English, 2 French, 1
German): 2 randomized, controlled trials, 4 case series,
and 7 case reports (Fig 1). There were 212 articles that
were excluded: 77 were not primary studies, 70 did not
involve pediatric patients, 29 did not involve spinal manipulation,
32 did not report an adverse event, and 4
were irretrievable. A full list of excluded articles is available
from the corresponding author.
We identified 14 cases of direct adverse events (Table
1), [27–36] 9 of which were classified as serious and resulted
in hospitalization, permanent disability, or death. [27–33] In
10 of 14 cases, the adverse events occurred within 24
hours of spinal manipulation. [27, 29, 31–33, 35–37] Each case involved
a chiropractor and was reported in the United
States. We identified an additional 20 cases of delayed
diagnosis and/or inappropriate provision of chiropractic
care (type of spinal manipulation unspecified in all
cases) that resulted in indirect adverse events. [37–41] Seven
cases involved delayed treatment of cancer (eg, diabetes,
aggressive osteosarcoma, metastatic neuroblastoma). [40, 41]
Two cases involved delayed treatment for meningitis,
and 1 case involved delayed treatment for embryonal
rhabdomyosarcoma. [37, 38] Each of the latter 3 cases resulted
in death [37, 38] (Table 2).
We were unable to combine data or conduct a priori
subgroups analyses because of methodologic heterogeneity between trials. [35, 36] Below, we describe the 2 clinical
trials and the nature and severity of adverse events
related to pediatric spinal manipulation. The remaining
direct and indirect adverse events are described in Tables
1 and 2.
Two trials were included. [35, 36] The first trial randomly
assigned 171 children to 1 of 2 active treatment groups;
both groups received spinal manipulation (the only discernable
difference was that 1 group waited 2 weeks to
start therapy).  Two adverse events were reported, both
of moderate severity (ie, required medical attention).
One case involved the onset of severe headaches and
stiff neck after cervical manipulation, which improved
gradually over the next 2 weeks with additional soft
tissue therapy. Neither the parent nor the child could
recall any previous symptoms involving serious headaches
or stiff neck. A second case involved the onset of
acute lumbar pain postmanipulation, which also resolved.  The second study was a randomized, controlled
trial of 20 children (9 received treatment and 11 served
as controls) that reported 2 minor adverse events involving
1 case of midback soreness that resolved after a few
days and 1 case of irritability for a short period posttreatment.  The authors concluded that the patients tolerated
the treatments well with only minimal, self-limiting
adverse effects. 
To our knowledge, we report the first systematic review
of adverse events related to pediatric spinal manipulation
irrespective of language. We identified 14 adverse
events in 10 reports, 9 of which were serious and resulted
in hospitalization, permanent disability, or
death. [27, 29–34] An additional 20 cases of delayed diagnosis
and/or inappropriate provision of spinal manipulation
resulted in indirect adverse events. [37, 38, 40, 41] Case reports
and case series can be interpreted as spontaneous reporting
or “passive” surveillance. Although they are useful to
demonstrate the type and nature of adverse events,
these reports do not provide information on the incidence
of adverse events because of the lack of data
regarding the total number of manipulations provided
(ie, denominator data).
Spontaneous reporting of adverse events is well
known to underestimate risk. An example of the limitations
of passive surveillance was documented by a British
survey of neurologists that was meant to ascertain
cases of serious neurologic complications occurring 24
hours post– cervical manipulation, in which 24 respondents
identified 35 such cases over the previous year;
none of these had been reported previously.  Lessons
from spontaneous reports of adverse drug reactions suggest
that 10% of serious adverse events are reported. 
The serious concerns regarding both the quantity and
quality of these spontaneous reports limit assessment of
causation. Given the large numbers of children who
have received spinal manipulation during the decades
assessed by our search strategy, adverse events resulting
from spinal manipulation are either remarkably rare or
A number of risk factors may predispose a child to an
adverse event as a result of spinal manipulative procedures,
including immaturity of the spine, rotational manipulation
of the cervical spine, and high-velocity spinal
manipulations. [44–47] We found that all 9 serious adverse
events (eg, death resulting from subarachnoid hemorrhage,
paraplegia, etc) occurred in children under 13
years of age. [30, 32, 34] In a case series, Ragoet  presented 3
cases of dislocated atlas as a result of pediatric spinal
manipulation. Evidence suggests that there is a strong
correlation between severity of injury to the spinal cord
and the immaturity of the spine  and that the atlas
(cervical vertebra 1 [C1]) and dens of the axis (C2) of
children are more vulnerable to trauma than those of
adults.  Although 5 of our serious adverse-event reports
did not specify the type of spinal manipulation used, 2 of
the 4 that reported serious adverse events specified that
the practitioner used rapid and/or strong rotational maneuvers. [27, 31]
The majority of complications attributed to
spinal manipulative therapy have occurred as a result of
rotational manipulation of the cervical spine.  In addition,
high-velocity manipulations of the spine have the
potential for serious complications resulting from diagnostic
error/inadequate patient assessment.  Although
the authors did not clearly specify the type of spinal
manipulation provided, 2 of the severe adverse-event
reports identified underlying risk factors (spinal cord
astrocytoma, congenital occipitalization) that may have
predisposed the child to the subsequent serious adverse
event (ie, quadriplegia, unsteady gait). [29, 34] An error in
the diagnosis of any number of preexisting conditions
such as arteritis, arthritic and cardiac conditions, clotting
abnormalities, meningitis, or vertebrobasilar insufficiency
may predispose children to neurologic and/or
vertebrobasilar complications. [45, 48–50]
A major challenge in proving or refuting causation
between pediatric spinal manipulation and serious adverse
events is the lack of sufficient randomized trials.
Unfortunately, like randomized trials of conventional
treatment, many randomized trials of CAM fail to adequately
evaluate for potential adverse events. [51, 52] In particular,
the 2 trials included in this review failed to
adequately describe most of the 10 recommendations on
reporting harms-related issues suggested by the Consolidated
Standards of Reporting Trials (CONSORT) statement. [35, 36, 53] Moreover, developing risk estimates for rare
events requires population-based sampling. For this reason,
our review was not limited to randomized, controlled
trials but assessed all reported primary medical
literature including observational studies and reports. It
is concerning that modeling from reports of adverse drug
reactions suggests that more than 1 to 3 spontaneous
case reports of rare or uncommon adverse events is
unlikely to be coincidental. [54, 55]
The only other previous review of this topic was
narrative, not systematic.  The authors neglected to include
a number of potentially important databases (eg,
Central, Embase, ICL) and did not search for non-English
reports. [57–59] Although they concluded that the risk
of neurologic and/or vertebrobasilar complications from
chiropractic manipulation was 1 in 250 million pediatric
visits,  we feel that this estimate is inaccurate and likely
underestimates risk. Numerator data were derived from
incomplete assessment of cases identified in the medical
literature, and denominator data were based on an estimated
number of chiropractic visits made by children in
the United States. Although our search strategy was
more comprehensive, we did not feel comfortable creating
risk estimates with an uncertain denominator. We
urge the development of an active surveillance model to
prospectively gather data about the quantity and quality
of adverse events so that risk estimates can be made with
It is difficult to know the cause for the identified
indirect adverse events (eg, delayed diagnosis and/or
inappropriate provision of spinal manipulation). We
postulate that this is related to lack of sufficient pediatric
training for CAM providers. We have recently collected
survey data on the knowledge, attitudes, and behavior of
chiropractors and osteopaths with regards to children in
their practice. Of 287 respondents, 71% graduated between
1992 and 2002, 78% of the respondents identified
1 semester or less of formal pediatric education during
their training, 72% received minimal or no pediatric
clinical training, and 93% recommended increased pediatric
training in their schools.  Collaborating with experts
in pediatric education toward developing a standardized
pediatric curriculum for CAM providers may
offer a way forward. Such collaboration should involve
the development of guidelines for medical referrals, joint
integrative care between physicians and CAM providers,
61 and the development of a scope of practice for
pediatric chiropractic and osteopathic care. Despite what
some have advised, [24, 26] many children continue to visit
chiropractors, and many chiropractors continue to treat
children.  We believe collaboration of this nature would
result in improved patient safety.
Our study has several limitations. First, we uncovered
mostly case reports. Many of the cases contained limited
data, and assessment of the validity of case reports is
generally insufficient to reach conclusions regarding
causality. [52, 54] However, to exclude the case reports
would have severely biased our results because it would
not have allowed for the identification of potentially
uncommon and unexpected adverse events, [54, 62, 63] which
may differ from those detected in clinical trials. 
our search strategy did not allow for systematic identification
of indirect adverse events (eg, delayed or missed
diagnoses); therefore, these indirect adverse events are
likely underestimated. Concerns regarding chiropractic
care have been raised about advice given regarding childhood
immunizations, frequency of radiographs, recommendations
regarding dietary supplements, and lack of
familiarity with serious childhood conditions resulting in
delayed diagnosis of a serious medical condition.  These
concerns were incompletely captured by our review.
Finally, we excluded cases that were only identified in
medicolegal proceedings or the lay press. [65–67] Our search
strategy was not designed to identify such reports, and to
include these cases would create a false impression that
they were the only ones reported in the potentially vast
non–health-specific, non–peer-reviewed resources.
Spinal manipulation is common among children, and
although serious adverse events have been identified,
their true incidence remains unknown. Randomized,
controlled trials will likely reveal common minor adverse
events, [20, 35, 36] and these events must be better reported.
Prospective population-based studies are needed
to identify the incidence of serious rare adverse events
associated with spinal manipulation. Patient safety demands
a greater collaboration between the medical community
and other health care professionals, particularly
chiropractors, such that we can investigate and report
harms related to spinal manipulation together. In the
interim, clinicians should query parents and children
about CAM usage and caution families that although
serious adverse events may be rare, a range of adverse
events or delay in appropriate treatment may be associated
with the use of spinal manipulation in children.
Dr Vohra is an Alberta Heritage Foundation for Medical
Research Population Health Investigator and recipient of
a Canadian Institute of Health Research New Investigator
Award. Dr Johnston holds a Sick Kids Foundation
Duncan L. Gordon Fellowship.
We thank Ellen T. Crumley for conducting the electronic
searches; Ashish Mahajan and Denise Adams for
assistance with screening and data extraction; Linda
Slater and Dominic Allain for assistance with translation;
and Don Spady for constructive feedback.
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