Angela J. Todd, MSc, a Matthew T. Carroll, PhD, b Anske Robinson, PhD, c and Eleanor K.L. Mitchell, PhDc,d
ABSTRACT
Objective: The purpose of this studywas to review the literature for cases of adverse events in infants and children treatedby chiropractors or other manual therapists, identifying treatment type and if a preexisting pathology was present.Method: English language, peer-reviewed journals and non–peer-reviewed case reports discussing adverse events(ranging from minor to serious) were systematically searched from inception of the relevant searchable bibliographicdatabases through March 2014. Articles not referring to infants or children were excluded.Results: Thirty-one articles met the selection criteria. A total of 12 articles reporting 15 serious adverse events werefound. Three deaths occurred under the care of various providers (1 physical therapist, 1 unknown practitioner, and 1craniosacral therapist) and 12 serious injuries were reported (7 chiropractors/doctors of chiropractic, 1 medicalpractitioner, 1 osteopath, 2 physical therapists, and 1 unknown practitioner). High-velocity, extension, and rotationalspinal manipulation was reported in most cases, with 1 case involving forcibly applied craniosacral dural tension andanother involving use of an adjusting instrument. Underlying preexisting pathologywas identified in amajority of the cases.Conclusion: Published cases of serious adverse events in infants and children receiving chiropractic, osteopathic,physiotherapy, or manual medical therapy are rare. The 3 deaths that have been reported were associated with variousmanual therapists; however, no deaths associated with chiropractic care were found in the literature to date. Becauseunderlying preexisting pathology was associated in a majority of reported cases, performing a thorough history andexamination to exclude anatomical or neurologic anomalies before applying any manual therapy may further reduceadverse events across all manual therapy professions. (J Manipulative Physiol Ther 2014;xx:1-14)Key Indexing Terms: Chiropractic;Manual Therapy; Safety; Infant; Children; Pediatrics; PatientHarm; Adverse Effects
A2010 survey of doctors of chiropractic acrossEurope and the United States1 found that 5% to11% of their client visits were pediatric patients,
with an earlier worldwide study reporting in excess of30 million chiropractic treatments are given to children
annually.2 The safety of chiropractic care for infants andchildren has been questioned by health practitioners andcommunity members.3-8 In Australia, the Friends ofScience in Medicine has called for a ban on chiropracticcare for children, claiming that heavy manipulation puts thelives of children at risk9 based on the inaccurate reportingof a child having suffered a neck fracture after chiropractictherapy (dural tension technique and cranial therapy). Areport by the Australian Health Practitioners RegistrationAuthority (AHPRA)10 cleared the chiropractor of anywrongdoing when expert radiological evidence showed thechild had an undetected congenital cervical spondylolysisand there was no evidence of a fracture. Vohra et al8 notethat chiropractic management of infants and children safetydata is virtually nonexistent, and others also expressconcern about the lack of beneficial evidence supportingchiropractic care for children.11 This further highlights thestated need for more randomized controlled trials (RCTs).1
However, in contrast to this reported lack of evidence,Rome12 insists that there has been a considerable number ofresearch articles and textbooks published in Europe espousingthe benefits of manual therapy for children and infants,particularly the work of Biedermann.13 A consensus
a Chiropractor, Private Practice; PhD Student, Department ofRural and Indigenous Health, Faculty of Medicine, Nursing andHealth Sciences, School Of Rural Health, Moe, Victoria, Australia.
b Senior Research Fellow, School of Rural Health–Churchill,Monash University, Churchill, Australia.
c Lecturer, Department of Rural and Indigenous Health, Schoolof Rural Health, Monash University, Moe, Australia.
d Lecturer, School of Rural Health–East Gippsland, MonashUniversity, Bairnsdale, Australia.
Submit requests for reprints to: Angela J. Todd, B.App.Sci(Chiro) Grad Dip (Chiro Paed) MBiomedSc, PO Box 1500 Sale,Victoria 3850, Australia. (e-mail: [email protected]).
Paper submitted June 16, 2014; in revised form August 19,2014; accepted August 28, 2014.
document14 supported the recommendation for standards ofchiropractic care developed for children and clearly outlinedbest practice for the chiropractic care of infants, children, andadolescents, including when a therapeutic trial is reasonable,using evidence-based practice, as well as altering techniqueselection and application based upon the unique anatomy andphysiology of infants, children, and adolescents.
It is not clear if the publicized concerns about the safety ofchiropractic and other manual treatments for infants andyoung children are supported by published evidence.Therefore, the purpose of this review is to examine allreported cases of serious adverse events caused by practi-tioners who apply manual therapies (ie, chiropractors/doctorsof chiropractic, physical therapists, medical physicians,
doctors of osteopathy, and other manual therapists) whencaring for infants and children, with particular focus on thetypes of treatment applied, the field of the treatingpractitioner, and whether a preexisting, undiagnosed pathol-ogy was present.8,15
METHODS
The scientific literature was systematically searchedusing the terms summarized in Figure 1 in the locationslisted in Table 1. The search of published peer-reviewedarticles and gray literature included events documented byany manual therapy health provider (ie, chiropractors/
Records identified from Grey Literature
(n = 43)
Records identified through database searching
(n = 17,392)
Titles and Abstracts screened after duplicates removed
(n = 16,566)
Records excluded (n = 16,532)
Full-text articles assessedfor eligibility
(n = 48)
Full-text articles excluded(n = 17)
Studies included in review(n = 31)
Articles identified from manual search of reference lists
(n = 14)
Figure 1. Search strategy.
2 Journal of Manipulative and Physiological TherapeuticsTodd et alMonth 2014Serious Adverse Events of Manual Therapies for Children
doctors of chiropractic, physical therapists, medicalphysicians, doctors of osteopathy, and other manualtherapists). Throughout this article, the term physicaltherapist (a term used in the United States) is used inpreference to physiotherapists (used in other countries torefer to the same professional type).
Only articles published in the English language weresearched. All available articles published from the inceptionof searchable bibliographic databases to March 2014 wereincluded. EMBASE, AMED, BIOSIS previews, MEDLINE,Maternity and Infant Care, OVID, CINAHL, Psychinfo,PubMed, INDEX to Foreign and Legal Periodicals, SCO-PUS, Science Direct, Index to Chiropractic Literature, andPubMed Central databases were searched.
Web sites, books, and gray literature were searchedincluding Google Scholar and 2 chiropractic Web sites,the International Chiropractic Pediatric Association andJournal of Vertebral Subluxation Research. The bibliog-
raphies of seminal articles were screened to identify anyadditional articles.
Abstracts were screened for those discussing manualtherapy of any kind on infants and children. After readingthe relevant full texts, articles were included in this review ifthey clearly discussed adverse events (mild, moderate, orsevere). Articles were excluded if they were commentariesnot reporting case information, the details of adverse eventdata collection were not clear, there was no discussion ofadverse events, or the articles did not discuss manualtherapy with children.
The full text of each documentwas analyzed to identify thenature of the adverse event; the practitioner type; techniqueapplied; and evidence of any undiagnosed, preexistingpathology. Adverse events were defined as mild (transienteffects lasting b24 hours, eg, crying or discomfort), moderate(requiring medical/general practitioner treatment), or severe(requiring hospital treatment)16
Table 1. Literature Search Results
Database Abstracts Screened Articles Meeting the Inclusion Criteria (Excluding Duplicates)
Embase 762 12 articles: Miller et al,39 Wilson et al,41 Zimmerman et al,52
Humphreys,21 Alcantara et al,25,35-38 Posadzki and Ernst,24
Simonian and Staheli,43 and Marchand16
AMED 3 1 article: Vohra et al8
Manual search of reference list revealed additional 8 articles: Shafrirand Kaufman,53 Ziv et al,54 Jacobi et al,46 L'Ecuyer,55 Klougart et al,51
Rageot,47 Held,66 LeBeouf et al50
Biological Abstracts, 1980-April 2009 15 NoneBiosis Previews, 1969-2008 1 NoneOvid Medline, 1948-June 2009 7 NoneMaternity and Infant Care 0 –Psychology Information 1967-April
week 2 20090 –
Ovid (Books@Ovid; Search All Ovid Journals) 155 1 article: Biedermann13
Index to Foreign Legal Periodicals 1985-2009 0 –Scopus 12 1 article: Gotlib and Rupert19
Science Direct 241 1 article: Spigelblatt45
Index to Chiropractic Literature 15,691 3 articles: Pistolese,17 Gleberzon et al,20 and Brand et al18
PubMed Central 1 NoneICPA independent chiropractic Web site 4 NoneGoogle Scholar 3 NoneJVSR Web site reviewed 257 NoneNCBI (National Library of Medicine) 16 NoneCINAHL 224 14 articles: Struewer et al,40 Miller and Benfield,26 Doyle,44 Holla
et al,42 Hayes and Bezilla,27 Hayden et al,28 Dobson et al,22
Pohlman and Holton-Brown,23 Sawyer et al,29 Koch et al,30,31
Bronfort et al,34 Philippi et al,32 Rowe et al33
Manual search of reference lists revealed additional 6 articles: Wiberget al,59 Straub et al,60 Sandell et al,61 Balon and Aker,62 Khorshidet al,63 Olafsdottir et al64
Gray literature searched including leadingchiropractic pediatric texts printed in theUnited States and Australia andAustralian newspapers
43 items None (relevant newspaper articles cited in introduction)
AMED, The Allied and Complementary Medicine Database; CINAHL, Cumulative Index of Nursing and Allied Health Literature; JVSR, Journal ofVertebral Subluxation Research.
3Todd et alJournal of Manipulative and Physiological TherapeuticsSerious Adverse Events of Manual Therapies for ChildrenVolume xx, Number
RESULTS
The search captured 17435 potential articles, andof that, 48published, peer-reviewed articles were reviewed (Table 1), 31of which met the selection criteria (all 31 articles aresummarized in Appendix A). Included were 5 systematicreviews of the literature,8,17-20 5 narrative reviews, 21-25 4cross-sectional surveys,16,26-28 6 randomized controlledtrials,29-34 4 Practice Based Research Network (PBRN)survey studies,35-38 4 case studies and 1 case series,39-43 and 2discussion papers.44,45 The details of all adverse events resultsare summarized in Table 2. This includes 15 instances ofserious adverse events involving the application of some formofmanual therapy on children younger 18 years.Moderate andmild adverse events are also described (Table 2).
High-velocity, low-amplitude thrust (HVLA) spinalmanipulative therapy (SMT) was applied in 10 of the 15cases of serious adverse events. In addition, in 8 of the 15cases of a serious adverse event, it was revealed that beforethe application of chiropractic or manual therapy, there waspresent a preexisting but undetected underlying pathologyor existing neurologic symptoms. Three deaths wererecorded, and 2 of these were in infants under 3 monthsof age who had previously been healthy.
DISCUSSION
This review of the literature varies from previousreviews in that it looks into the adverse events for alltypes of manual therapists and not just chiropractors andcombines this information with the type of technique thatwas used and also finally the presence of any preexistingpathology. This review of the literature identified that someauthors suggest that adverse events can occur after manualtherapies; however, the reported incidence appears to berare and may be heightened by preexisting pathologies orthe use of inappropriate techniques or inappropriatelyapplied techniques. Three deaths have been reported to beassociated with any type of manual therapy: a 3-month-oldinfant treated by a physical therapist using both electricalcurrent and spinal manipulation46; a craniosacral therapistincorrectly applying craniosacral therapy42; and a deathreported in France in the 1960s with no details of thetherapist type or technique used, although it is known thatthe child had underlying pneumonia.47 All 3 of these deathswere associated with European-based practitioners in aregion where regulation of chiropractic care is relativelyrecent. These 3 deaths reflect similar findings from previousreviews that misdiagnosis, failure to recognize the onset orprogression of neurological symptoms, improper technique,SMT performed in the presence of clotting disorders, orpoor spinal structural integrity increases the likelihood of anadverse event.48
This review found that HVLA thrust techniques weremore often reported as the technique used in adverse events
in infants and children and further research is required todetermine if this is the result of the specific manipulationsinvolved in HVLA, is an artifact of the greater frequencywith which this treatment is used across all therapy types, oris the result of limitations in the experience and training ofthe manual therapist. It is also necessary to determinewhether particular techniques or forces are more appropri-ate for different ages, perhaps in accordance with the knownosteoligamentous tensile strength limits, the anatomicaldevelopment of the spine and nervous system in the child,and the potential for subcatastrophic events, especially ininfants less than 3 months of age.49
In addition to the 15 serious events that have beenreported, there have been 775 mild to moderate adverseevents. This includes 604 cases of crying, soreness, ortransient headache,16,26,33,36-38,50 and 1 case of syncope51
recorded after chiropractic care. There were a further 35cases of soreness or transient headache27,32 after osteo-pathic treatment. Finally, there were 50 cases of transientapnea (returned to normal in 4 breaths) with vegetativeresponses30 and 87 cases of short lasting (seconds)marked bradycardia, in infants after SMT to the uppercervical spine in otherwise healthy children from medicalmanipulators.31 These responses to manual medicaltherapy were recorded as part of an experiment in ahospital setting, and further investigation of this poten-tially serious physiological phenomenon in infants lessthan 3 months of age is warranted.
Manual medicine practitioners in Europe tend to useSMT for children from birth,12,13 and radiographs arealmost always undertaken to exclude skeletal pathologybefore the application of SMT. The use of ultrasound,before full cervical spine ossification, pediatrician screen-ing, and appropriate neurologic examination to screen outthose children with an underlying pathology and to referthem appropriately, should be a consideration for all thoseusing manual therapy in infants with congenital torticollisor unusual body posturing.
Although this review has looked at all types of manualtherapies involving children, it should be noted that in termsof chiropractic treatments, the number of treatments for thepopulation is extensive; however, there are no reporteddeaths and only 7 severe adverse events,41,47,51-55 4 ofwhich were associated with an underlying preexistingpathology52-55 and the health status of 1 other childunknown before care.47 The HVLA spinal manipulationwas the technique that was reported to be most commonof these rare recorded adverse events associated withchiropractic care.
Chiropractors are trained to use techniques that best suitthe age and condition of the patient. Undergraduates aretaught to modify the level of force during manipulationsuch as when used on a child and a variety of techniques canbe considered for neonates or infants.56,57 In a study of 956European chiropractors,16 more than 96% reported treating
4 Journal of Manipulative and Physiological TherapeuticsTodd et alMonth 2014Serious Adverse Events of Manual Therapies for Children
Table 2. Adverse Events After Manual Therapy
Original ReportNo. ofAdverse Events Adverse Event Practitioner Type Technique
Alcantara et al38 2 Soreness Chiropractors SMT NRAlcantara et al36 9 Soreness Chiropractors SMT NRAlcantara et al37 3 (chiropractor
reported)2 (parentreported)
Stiffness; soreness Chiropractors SMT, varied NR Humphreys21
Doyle44
(continued on next page)
5Todd et alJournal of Manipulative and Physiological TherapeuticsSerious Adverse Events of Manual Therapies for ChildrenVolume xx, Number
children, and they estimated that they reduced themagnitude of their thrusts with infants under 1 year ofage by 90% of that used on adults, with the level beinggradually increased in line with the age of the child.Chiropractors, osteopaths, physical therapists, and manualmedicine practitioners all use very similar modified SMTand stretching techniques when treating very young infantsand children.12
LimitationsThis literature review may have missed relevant articles
because the search was only conducted in Englishpublications. A further limitation would be that the termsreferring to manipulation vary considerably in the literatureand so what is described as spinal manipulation can vary tobe very light touch to the use of a mechanical instrument tothat of a modified HVLA thrust.58 Biedermann13 is a
Table 2. (continued)
Original ReportNo. ofAdverse Events Adverse Event Practitioner Type Technique
Relevant UnderlyingPathology Further Cited by
Marchand16 23 moderate534 mild
Soreness; headacheCrying; sleeplessness
Chiropractors Varied and notspecified which lead toeither adverse reactionModified SMTCraniosacral therapyActivator instrument
6 Journal of Manipulative and Physiological TherapeuticsTodd et alMonth 2014Serious Adverse Events of Manual Therapies for Children
European medical manual therapist with decades ofexperience and none of Biedermann's comments regardingmedical manipulation of infants and its apparent safetywere included in the results because this was merelycommentary and there were no specific cases reported. TheRCTs of Wiberg et al,59 Klougart et al,51 Straub et al,60
Sandell et al,61 Balon et al,62 Khorshid et al,63 andOlafsdottir et al64 were reviewed but excluded from thematrix for this article because there was no mention ofwhether adverse event data were recorded.
RecommendationsAdverse Event Reporting. More comprehensive methods ofadverse event recording across all manual therapyprofessions are recommended. For example, the Chiro-practic Patient Incident Reporting and Learning Systemlaunched in the UK in 200565 is now accessible toAustralian chiropractors. This adverse event reportmonitoring service is available for chiropractors to reportanonymously. The Chiropractic Patient Incident Reportingand Learning System reporting system is not currentlyavailable to all other users of manual therapy so reportedevents may be overrepresented by chiropractors. Weshould consider how to include all manual therapists inthe collection of this type of data and ensure thatpractitioners use the service and make changes based onthe reports.
Registration boards of all professions involved in thisstudy have the primary role of reducing risk to thecommunity at large from poor practitioner conduct anddelivery of care. For example, in Australia, this is throughthe AHPRA.
A related issue canvassed by Vohra et al8 is that not allparents of children treated by a chiropractor will return tothe chiropractor if they believe there has been an adverseevent. Instead, parents may turn to their medical practi-tioners or other health care providers such as maternal andchild health nurses or hospitals, leading to possibleunderreporting of adverse events. The regulatory bodyAHPRA has a role in providing an avenue for reporting ofadverse events that is independent and available toeveryone in the community.
Undergraduate Education. To enhance the safe application ofmanual therapy on children, regulatory bodies, and alsouniversities could ensure that undergraduates are exposed toa broad case mix of patients including children and that arange of age appropriate techniques are taught. Furtherstudy in this area is required.
In terms of chiropractic training, undergraduateeducation prepares chiropractors for working with allages of patients and is part of the worldwide require-ments for chiropractic education and accreditation.Likewise, osteopaths, manual medicine practitioners,and physical therapists are trained in the assessment
and application of therapy across all ages of people. Areview of the rigor and quality of postgraduate coursesavailable is also needed.
All Manual Therapists Need to Be Diligent in Clinical Practice andApplication. Because some of the adverse events reported inthe literature may have been avoided if a better history andexamination were completed or if there had been a bettertechnique selection or application, it might be appropriate tofurther investigate both undergraduate and postgraduatetraining of all types of manual therapy practitioners. Furtherresearch is recommended to investigate appropriate tech-nique usage, especially of HVLA, and the range andnumber of case mix exposures that would deem someonecompetent to care for children.
CONCLUSION
Published cases of serious adverse events in infants andchildren receiving chiropractic, osteopathic, physiothera-py, or manual medical therapy are exceedingly rare. Therehave been no cases of deaths associated with chiropracticcare reported in the academic literature to date. Threedeaths were reported caused by other types of manualtherapists. Performing a thorough history and examinationto exclude anatomical or neurologic anomalies before theprovision of care, appropriate technique selection and itsapplication may further reduce adverse events across allmanual therapy professions.
Practical Applications• Chiropractic, physiotherapy, osteopathic, andmanual medicine practitioners all carry a rarebut material risk when applying SMT toinfants and children.
• Most events found in this study had anunderlying pathology; thus, the presence ofan underlying pathology of the bone ornervous system may increase the risk of aserious adverse event occurring in thepediatric population.
• Techniques should be modified to suit theage, anatomy, and unique physiology of theyoung patient especially for children under 3months of age.
• The application of modified SMTs by adoctor of chiropractic in a healthy childappears no less safe than SMT applied by aphysiotherapist, osteopath, or manual medi-cine practitioner.
7Todd et alJournal of Manipulative and Physiological TherapeuticsSerious Adverse Events of Manual Therapies for ChildrenVolume xx, Number
ACKNOWLEDGMENTS
The authors thank Dr Janice Chesters for her early helpin the reviewing of the articles included in the matrix andNaomi Knoblauch for assistance with formatting, gram-matical editing, and helping locate references.
FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST
This project has been supported with funding from theAustralian Government Department of Health and Ageingunder the Primary Health Care Research, Evaluation andDevelopment initiative. No conflicts of interest werereported for this study.
CONTRIBUTORSHIP INFORMATION
Concept development (provided idea for the research):A.T.
Design (planned the methods to generate the results):A.T., A.R.
Supervision (provided oversight, responsible for organi-zation and implementation, writing of the manuscript): A.R.,E.M., M.C.
Data collection/processing (responsible for experiments,patient management, organization, or reporting data): A.T.
Analysis/interpretation (responsible for statistical analysis,evaluation, and presentation of the results): A.T., A.R., E.M.
Literature search (performed the literature search): A.T.Writing (responsible for writing a substantive part of the
manuscript): A.T.Critical review (revised manuscript for intellectual
content, this does not relate to spelling and grammarchecking): A.T., A.R., E.M., M.C.
Other (list other specific novel contributions).
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55. L'Ecuyer JL. Congenital occipitalization of the atlas withchiropractic manipulations: a case report. Nebr State Med J1959;44:546-50.
56. Gleberzon BJ. Chiropractic name techniques in Canada: acontinued look at demographic trends and their impact onissues of jurisprudence. J Can Chiropr Assoc 2002;46:241-56.
57. Mykietiuk C, Wambolt M, Pillipow T, Mallay C, GleberzonBJ. Technique systems used by post-1980 graduates of theCanadian Memorial Chiropractic College practicing in fiveCanadian provinces: a preliminary survey. J Can ChiroprAssoc 2009;53:32-9.
58. Wenban AB. Inappropriate use of the title “chiropractor” andterm “chiropractic manipulation” in the peer-reviewedbiomedical literature. Chiropr Osteopat 2006;14:16.
59. Wiberg JMM, Nordsteen J, Nilsson N. The short-term effectof spinal manipulation in the treatment of infantile colic: arandomized controlled clinical trial with a blinded observer.J Manipulative Physiol Ther 1999;22:517-22.
60. Straub WF, Spino MP, Alattar MM, et al. The effect ofchiropractic care on jet lag of Finnish junior elite athletes.J Manipulative Physiol Ther 2001;24:191-8.
61. Sandell J, Palmgren PJ, Bjorndahl L. Effect of chiropractictreatment on hip extension ability and running velocityamong young male running athletes. J Chiropr Med 2008;7:39-47.
62. Balon J, Aker PD, Crowther ER, et al. A comparison of activeand simulated chiropractic manipulation as adjunctive treat-ment for childhood asthma. N Engl J Med 1998;339:1013-20.
63. Khorshid K, Sweat RW, Zemba D, Zemba BN. Clinicalefficacy of upper cervical versus full spine chiropractic careon children with autism: a randomized clinical trial.J Vertebral Subluxation Res 2006:1-7.
64. Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomisedcontrolled trial of infantile colic treated with chiropracticspinal manipulation. Arch Dis Child 2001;84:138-41.
65. Thiel H, Bolton J. The reporting of patient safety incidents—first experiences with the chiropractic reporting and learningsystem (CRLS): a pilot study. Clin Chiropr 2006;9:139-49.
66. Held JP. Dangers of cervical manipulation in neurology. AnnMed Phys (Lille) 1966:251-9.
9Todd et alJournal of Manipulative and Physiological TherapeuticsSerious Adverse Events of Manual Therapies for ChildrenVolume xx, Number
Systematic reviewsVohra et al8 Systematic review of the literature for
cases of adverse events involving theuse of manipulation on children(Inception-2007)
13 studies included from 13916identified in initial search (2 RCTs, 11observational studies); 14 cases ofadverse events (9 serious, 2 moderateand 3 minor).
Extensive and very systematic reviewofthe literature; chiropractors found tohave caused 5/9 serious events, 4 ofthese 5 chiropractic cases havingpreexisting pathologies or neurologicsigns and 5 nonserious events includeddiscomfort, pain, or crying. Physicaltherapist and unknown practitionercaused 1 death each. HVLA was notedin 6 cases; however, the technique/sused in the other 8 cases is unknown.Weakness of this article is that cryingand irritability noted as an adverse event
Pistolese17 Systematic review of all survey data(1966-1998; Medline and MANTIS)with quasi–meta-analysisInvestigates the recorded complicationsfrom chiropractic SMT (only injury datafrom chiropractic care in the United States)
From 3 major government surveys,estimated pediatric visits of N5 millionand cited only 2 reports of neurologic orvertebrobasiliar complication fromchiropractic care in the literature. Risk ofserious adverse event was extrapolated tobe 1 in 250 million pediatric visits.
Weaknesses of this article include thatonly injury data from chiropractic carein the United States were used so only2 of 8 known cases were reported.The 32 years of prevalence data isactually an estimate based on theactual data for the first 12 years(1966-1978). The accuracy of thisextrapolation is questionable.
Brand et al18 Major electronic databases searched forclinical trials on manual therapy appliedby chiropractors, osteopaths, andmanual medicine practitioners involvinginfants (1966-2004)
Quotes the following articles (detailselsewhere in this table): Includes 1death Jacobi et al46 and physiologicalchanges following medicalmanipulation Koch et al30
Koch et al31
No details of practitioner, type oftreatment, or discussion of how apneaand bradycardia was measured. Authorrepeatedly stating that a lack of RCTstudies on effectivenesswas evidence asto poor safety, also extensive use ofpersonal communications with expertsin the field instead of citing recordedcases and published literature.
Gotlib and Rupert19 Systematic review of the literature forcases of adverse events followingchiropractic care of children (2004-2007)
No critical analysis of any literaturereviewed. Zero cases of adverse eventsrecorded in the timeframe of the review,which included 1275 citations and57 eligible articles.
Review of literature-based evidence oneffectiveness and extrapolated to equalsafety. Implies poor-quality research forevidence equals poor safety.
Gleberzon et al20 Systematic review of clinical trialsinvestigating the effects of SMT onvarious clinical conditions affectingchildren (2007-2011); advancing aprevious study by Gotlib and Rupert19
16 clinical trials met inclusion andexclusion criteriaZero adverse events in any of the clinicaltrials reviewed, which involved a total of1809 children. All children receivedSMT or modified SMT.
Exclusion criteria meant no individualcase studies were included; therefore,cases of adverse events alreadypublished in the literature were notmentioned in this systematic review.
Narrative literature reviewsHumphreys21 Update of clinical research literature on
adverse events in children after spinalmanipulation (2007-2010)
Only 3 new studies identified. Reportsthat there were no serious adverseor catastrophic events.
Discusses limitations in previoussystematic reviews in classifyingadverse events.
Dobson et al22 Review of all publications ofmanipulative therapy providers foreffectiveness for colic treatment
Articles reviewing chiropractic,osteopathy, and cranial therapy for colic.Six studies involving 325 infants included.No serious adverse events involvingchiropractic or osteopathy. One deathcaused by craniosacral therapist.
Recognized variability in study qualityand discussed low numbers of infantsinvolved in each study; therefore,difficult to drawmeaningful conclusions.
Pohlman andHolton-Brown23
Review of the literature and summaryof the effects and safety of SMT forotitis media
49 articles in English with childrenunder 6 years: 17 commentary; 15 casereports; 5 case series; 8 reviews; and 4clinical trials. Forty-one chiropractic and142 osteopathic patients with OtitisMedia, with zero serious adverse events.
Grading for quality of articlesincluded; however, 17 commentaryarticles were included.
APPENDIX A. STUDIES INCLUDED IN REVIEW
10 Journal of Manipulative and Physiological TherapeuticsTodd et alMonth 2014Serious Adverse Events of Manual Therapies for Children
. (continued)
Study Study Details Key Findings Summary
Posadzki and Ernst24 Summary and critical evaluation of thedata from systematic review of spinalmanipulation for any pediatric condition(Inception-2011)
5 articles relating to effectiveness ofspinal manipulation in children.RCTs involving SMT, chiropractic orosteopathic therapy. Makes anecdotalreference to several hundred severe andlife-threatening adverse events
Reported adverse events are in relationto adult patients and not pediatric cases.Uses lack of effectiveness data found inthe review of literature to conclude thatspinal manipulation and chiropractic isnot recommended.
Alcantara et al25 An integrative review of the literatureto summarize the breadth and depthof chiropractic in the care of childrenwith constipation.
17 articles with 15 case reports,involving children from 3 weeks to8 years of age. Zero cases of adverseevents reported. Treatment appliedfrom low force SMT to HVLA SMT.
This is not a systematic review of theliterature, but an integrative review asnon–peer-reviewed articleswere included.
Randomized controlled trialsSawyer et al29 A prospective pilot study with
parallel-group, observer-blinded,randomized feasibility study of 22 patientswith chronic otitis media with effusion.Children, 6 months to 6 years, receivedactive or placebo SMT and results weremeasured using tympanometry, otoscopy,and parent diaries.
20 patients aged 6 months to 6 yearsrandomized to chiropractic HVLA-SMT(n = 9) or placebo SMT (n = 11); a totalof 200 chiropractic SMT visits, zeroserious adverse events resulted.
Weakness: Low number ofparticipants in each group.Practitioners not qualified orexperienced in using measuringdevices for effusion associated withchronic otitis media
Koch et al30 Prospective clinical trial of 199 infants toinvestigate vegetative reactions aftermechanical irritation of suboccipitalregion
199 infants received upper cervicalmanual therapy from a medicalmanipulator. Thrusts estimated to be 50N applied to all children with asymmetryand muscle tension disorders.Apnea and flushing of skin observedin 50 infants given the medicallyinduced impulse.
Changes in observed physiology onlyand not assessed with breathingmonitor or skin sensors.Equally, force of thrust estimated andnot measured in the study, so unsure ifthis is accurate.Clinical trial not blinded norrandomized to control for bias
Bronfort et al34 Pilot randomized controlled trial todetermine if chiropractic SMT in additionto optimal medical management resultedin clinically important changes in asthma-related outcomes, and secondly to assessthe feasibility of conducting a fullscale RCT
Total of 36 children 6-17 years22 children had an estimated 19 SMTsessions in the chiropractic SMT group.12 sham treatmentsAdverse events reported as none ineither group.
Two less patients than what wasrequired to be statistically significantcompleted the trial.Did not state the existence of adverseevents or not, so it is assumed thatnone occurred.
Koch et al31 Prospective clinical trial to measureheart rate changes in infants with KISSreceiving manual therapy from medicalmanipulators.
695 infants 1-12 months with nounderlying pathology. Radiographstaken of all infants prior to medicalmanipulation applied between 30 and70 N. No rotation applied only lateralflexion and extensionSevere short lasting bradycardiaobserved in almost 50% of all infantsless than 3 months receiving medicalmanipulation of upper cervical spine.Bradycardia was mild in children olderthan 4 months; 87 cases of severe, shortlasting bradycardia followingmedical manipulation.
All infants were monitored with ECGonly. Breathing changes (apnea),flushing of skin and blood pressurewere excluded due to movementartifacts. However, the measure of30-70 N was not assessed in everycase, so unclear if a higher force wasapplied to those infants experiencingsevere bradycardia.The target of 50 N and never morethan 70 N is an estimation only.Term chiropractic used throughoutdocument even though the therapyapplied was by medicalmechanical manipulation
Philippi et al32 Randomized controlled trial with blindingto assess improvement of asymmetry ininfants receiving osteopathic care
32 infants with postural asymmetry age6-12 weeks with at least 36 weeksgestational age. 16 in sham conditionand 16 given OMT. One visit a week for4 weeks. Follow-up over 10 months. Noserious adverse events resulted. 4 mildadverse events (increased vomiting,excessive crying)
There were only a small number ofparticipants in treatment group.
Rowe et al33 Pilot randomized controlled trial toexplore issues of safety, patientrecruitment and compliance,
6 cases of scoliosis treated with HVLAand 2 minor transient soreness.2 chiropractic patients
Very small number of cases sodifficult to draw efficacy conclusions.Also, 120 chiropractic interventions
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11Todd et alJournal of Manipulative and Physiological TherapeuticsSerious Adverse Events of Manual Therapies for ChildrenVolume xx, Number
120 chiropractic interventionsSerious adverse events reported as nil.
were with combined medical care, sothis may be different to the usualchiropractic intervention experience.
Observational surveysHayden et al28 Prospective cohort study to describe
current chiropractic practices in themanagement of low back pain inchildren and adolescents, includingtreatment outcomes, and factorsassociated with those outcomes
Random selection of chiropractorsin Canada who treated patients in the4-18 years age range.Practitioners must have had 5-yearexperience as a chiropractor, 2+pediatric patients per week minimum.A total of 53 patients and 310 visits withSMT used in 95% of child visitsComplications were reported as none.
39/54 practitioners dropped out ofstudy; therefore, the 53 pediatricpatients visits were taken from only15 practitioners.
Hayes and Bezilla27 Retrospective review of medical recordsof children under 19 years in the care ofosteopathic physicians in 2 US states
File notes of 346 pediatric patients in2 US states reviewed for adverse eventsand treatment aggravations followingosteopathic treatmentZero serious adverse events reported.31 treatment-associated aggravations(1 dizziness, 2 headache, 7 worseningsymptoms, 21 mild soreness and painrelated issues)
156 pediatric files were excluded fromanalysis due to only one visitoccurring and it was not noted ifadverse events were the reason forcessation of care.
Miller and Benfield26 Literature review and a retrospectivestudy of survey data to review thenumber of adverse events reported at achiropractic teaching clinic in the UK forchildren under 3 years of age, so thatrisks of potential adverse events couldbe put into context
Three-year study (2002-2004)5242 treatments from 697 Anglo-European Chiropractic College (AECC)files (nil excluded who had treatment)—serious adverse events reported as nil.4 mild events (crying b24 hours)Quotes the following articles(details elsewhere in this table):Vohra et al8
Pistolese17
Study relies only on data written bypractitioner in file post treatment.Potential for practitioner bias inrecording of any minor adverse event.Study does not include type of treatment
Miller et al39 Case series: Prospective data collectionfrom patient files and discharge surveyscompleted by mothers to describefeatures and outcomes of infant casespresenting for chiropractic care dueto breastfeeding difficulties
144 infants under 3 months all referredby a medical practitioner to achiropractic teaching clinicfor suboptimal breast feeding.Estimated average of 576 chiropracticmanual treatments (average of 4 visitsper infant)Adverse effects reported as nil.
Infants sent to chiropractor frommedicalpractitioner and screened for underlyinghealth pathologies prior to care.This may have reduced the incidence ofundetected pathology, since the groupalso had a higher than normal incidenceof birth intervention.
Marchand16 Cross-sectional Internet survey todetermine the number of pediatric visitsto a cohort of European chiropractorsover a 1-month period, noting conditionstreated and adverse events
93% of the 956 chiropractors surveyedtreated children with a total of 19821per month child visits.Zero severe adverse events23 moderate adverse events (soreness,headache), 534 mild adverse events(crying, not sleeping)Birth—23 months and adolescents were63% of child the reported visits
High number of practitioners and patientnumbers and discussed the limitations ofusing recall survey information.
Cross-sectional surveysAlcantara and Ohm35 Review of the files of 53 chiropractors
participating in a PBRN for casesof adverse events in pediatric patients
Data collected from informationin files, no treatment types listed.Selection bias in all data usedin survey because practitionerselected the files included for thePBRN themselves.
Alcantara et al38 Survey of parents with childrenunder chiropractic care
Data collected from informationin files, no treatment typeslisted. Selection bias in all data usedin review.
Alcantara et al36 Survey of parents and chiropractors ofpatients under 18 years undercare during a 1-year period of time.
Chiropractic survey of 577 patientsreceiving a total of 5.438 visits.3 treatment aggravations, 0 treatmentcomplications. Patient parent surveys for239 patients, 2 treatment-relatedaggravations, 0 treatment complications.
Most data collected from practices andparents affiliated with researchorganization. Selection bias in all dataused in review.
Case reportsSimonian and Staheli43 Report on cause of leg fractures in
2 children receiving physiotherapymanipulation
4 leg fractures in 2 children afterphysiotherapy manipulation of legcontractures. 1 child amyoplasiacongenital disorder
Study of only 2 cases
Holla et al42 Review of infant death aftercraniosacral therapy
3-month-old infantForced, held, flexion of entire vertebralcolumn by craniosacral therapist.Infant died of asphyxiation fromobstruction to upper airway inprolonged forced neck position
Does not reveal if techniquewas applied correctly or if therapistwas qualified
Wilson et al41 Report of an infant presenting withrib fractures after chiropractic care
3-week-old infant held upside downaround rib cage by chiropractorin assessment.Activator instrument applied to thethoracic spine of infant.7th and 8th posterior rib fractures notedon presentation at hospital emergencydepartment 5 days after chiropractic visit
No discussion of whetherthe Activator Instrument was placedon the rib cage where the fractureswere located.No discussion of whether the fracturesmay have occurred from being heldupside down around the waist/ribs.No description of the setting used onthe Activator Instrument, which variesthe force applied.
Struewer et al40 Review of a 17 year old withhematothorax after osteopathicthoracic spinal manipulation
Osteopathic physician applied seatedrotational and extension high-velocitythrust manipulation to 17 years oldwith thoracic spinal pain.Massive hematothorax caused as a resultof therapy by osteopathic HVLA thrust
Discussion throughout the articlerefers to chiropractic techniqueand dangers of chiropractic, whenthe therapist involved was anosteopathic physician.
Discussion papersSpigelblatt45 Position statement based on review
of literature and ad hoc surveycollection, including discussion ofcases of adverse events relating tospinal manipulation of children
Nonspecific data collection. Survey,literature review, opinions. No inclusionor exclusion criteria and no samplesizes. Quotes the following articles(details elsewhere in this table): Jacobi et al46
Zimmerman et al52
Position paper, selection, inclusion/exclusion bias, data collection, ad hoc,extrapolated data leads to author biasin results. Confuses efficacy withsafety to bias paper. Uses adult dataand applies findings to children.
Doyle44 Review of the literature regardingthe safety of pediatric care
12 articles reviewed referred toadverse events.Biedermann13
No serious adverse events reported inmore than 30000 treatments by medicalmanipulatorsLeboeuf et al50
2 mild adverse events (discomfort),from 171 pediatric patients interactionsQuotes the following articles(details elsewhere in this table):Pistolese17
Few diagrams or tables in the article tofollow the flow of data from thereviewed articles.Uses Biedermann commentary as partof justification of SMT.Conclusion of safety of chiropracticcare based on the results of the 12articles. No recommendation to collectadverse event reporting data in a morecomprehensive way.
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13Todd et alJournal of Manipulative and Physiological TherapeuticsSerious Adverse Events of Manual Therapies for ChildrenVolume xx, Number
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