New Study Condemns Spinal Manipulation for Children
By John W. Reggars DC, MChiroSc.

A new study by Dr. Sunita Vohra and colleagues from the Department of Pediatrics at the University of Edmonton, Alberta, Canada, cast doubts on the safety of spinal manipulation for children. The study published in the Journal of Pediatrics¹ involved a systematic review of the literature regarding adverse events associated with pediatric spinal manipulation. The authors found thirteen studies that met their inclusion criteria and from those studies 14 cases of direct adverse events were uncovered, 9 of which were considered serious and resulted in hospitalisation, permanent disability or death. In 10 of the 14 cases the adverse events occurred within 24 hours of the manipulation and according to the authors all cases involved a chiropractor and were reported in the United States. Further, the authors also identified a further 20 cases of delayed diagnosis or inappropriate provision of chiropractic care that resulted in adverse events. Some of these cases involved delayed treatment of cancer, meningitis and diabetes with some cases resulting in death.

The researchers concluded that although adverse events may be associated with pediatric spinal manipulation neither causation nor incidence rates can be inferred from the data and that a prospective population-based active surveillance study is required to properly assess the possibility of rare yet serious events as a result of pediatric spinal manipulation.

As you can imagine, this study resulted in reporting in the world-wide press. A Reuters article² stated “Dr. Vohra stressed that parents should be aware that symptoms of back and neck pain may often have a different cause in children than in adults. While body aches are common in adults, they are unusual in children and can be signals of serious illness.” “Parents should first talk to their child’s pediatrician about any symptoms, in order to rule out any serious problem, according to Vohra. Until more is learned, they suggest that parents be cautious about seeking this therapy for their children.”

Needless to say, the release of this study prompted several criticisms and rebuttals from the chiropractic profession. In particular, Anthony Rosner, Director of Research, Foundation for Chiropractic Education and Research, issued a Press Release outlining the shortcomings of the study.³

In part Dr. Rosner states “It is both important and commendable that these events have been brought to light in Vohra’s report. However, they must be viewed in the larger framework of three factors: (1) the total number of treatments administered to children; (2) the relative risks of medical procedures for the same conditions treated; and (3) the benefits of spinal manipulation in children, which have been amply described in the research literature. Lacking these considerations, this review presents a distorted and one-sided assessment of pediatric spinal manipulation.

Unfortunately, the review by Vohra falls short of its goals in its pursuits:

• Important studies involving pediatric patients who have successfully undergone spinal manipulation in resolving their complaints of ear infections (otitis media) have gone unnoticed.
• Another study in which the authors attribute adverse events to chiropractors in the United States instead involves physical therapists, most likely practicing in Germany.
• Yet another citation of adverse events occurring in a clinical trial describes nothing more than a short period of mid-back soreness and irritability, difficult to distinguish from a period of extended crying in another subject who was not even manipulated but was instead assigned to the placebo group.
• A final group of patients suffered from delayed diagnosis-which the authors erroneously attribute to one study that made no such mention of diagnoses at all but rather focused upon the direct consequences of manipulation per se.
• So the question remains whether the authors have truly accomplished their minimal objective. Did they actually present an accurate and balanced assessment of the literature addressing the adverse events associated with spinal manipulation? The answer appears to be in the negative.

It is also not at all clear whether all the spinal manipulations described were in fact administered by qualified chiropractors, an important consideration when one considers the risks involved with individuals who have not received complete training in manipulating areas of the neck. Only when the following criteria are met will a truly “accurate and balanced” assessment of the scientific literature have been made:

• The precise maneuvers applied to the patient;
• The complete qualifications of those administering these treatments;
• The several benefits of manipulations of the cervical area which in the literature have been shown to include the relief of headache, carpal tunnel syndrome, otitis media, colic, and enuresis (bed-wetting).

None of these standards have been met by Vohra’s review, such that it can only be greeted with extreme skepticism.”

While some of Dr. Rosner’s criticisms are justified I find others less convincing and factually incorrect.

Dr. Rosner makes several points regarding the total number of treatments administered to children, the relative risks of medical procedures for the same conditions and the benefits of spinal manipulation in children which has been amply described in the literature. While the first two of these points may be valid they are irrelevant to the current study. The study was not aimed at risk/benefit analysis but rather a report on adverse effects and notwithstanding criticism of the study’s methodology this is what the authors presented. Moreover, there is no scientific literature, which in anyway remotely investigates risk/benefit for spinal manipulation in children.

The final point made by Dr. Rosner regarding the benefits of manipulation in children being amply described in the literature is incorrect. For example Dr. Rosner cites important studies on the resolution of otitis media, colic, and enuresis with spinal manipulation, which have gone unnoticed. In 1999 Dr. Brian Budgell, well known for his research into somatovisceral reflexes, reviewed the literature relating to the effectiveness of spinal manipulation for the treatment of visceral disorders and concluded “Little original data exists in the research literature to support the use of spinal manipulation in the treatment of visceral disorders.”⁴ My own recent brief review of the literature would indicate that this status is unchanged.

For enuresis and otitis media the literature contains mostly single case studies and conference proceedings, which has as yet have not been published in the peer reviewed literature. One controlled trial was undertaken in 1994⁵ to assess the effectiveness of chiropractic in the treatment of enuresis but the results did not reach statistical significance and there were several major methodological flaws in the study. Leboeuf et al⁷ also conducted a prospective outcome study on 171 children with nocturnal enuresis and concluded, “In the absence of a control group there appears to be no validity in the claim that chiropractic is a treatment of choice for functional nocturnal enuresis.” Most recently a Cochrane systematic review was conducted on the treatment of nocturnal enuresis with complimentary therapies and the researchers found that there was weak evidence to support the use of some complimentary therapies, including chiropractic treatment.⁸ Similar to the evidence for enuresis the treatment of otitis media with chiropractic is also lacking with only single case reports and one retrospective study on 46 children with otitis media. In this study there were significant methodological flaws including no control group no randomisation. Interestingly, the authors of this study cited as a limitation of their study a lack of data on the natural history of otitis media. I would agree that this was a major limitation as like enuresis otitis media has a very favourable natural history with 80% of children without effusion improving within three days and 74% those with effusion improved within three months.⁹ With respect to colic the literature contains some better designed trials, the best of which a blinded randomised control trial showed no difference in improvement between the active and control group. A previous article in COCA News reviewed the literature on this subject.¹⁰ I can find no relevant reason why Dr. Rosner would include carpal tunnel syndrome as a condition successfully treated by manipulation in children, as it is typically not a condition which effects children and I could find no literature to support this claim.

It is true that the study attributes some adverse events to chiropractic manipulation when in fact the manipulations were not performed by chiropractors and the statement that “Each case involved a chiropractor and was reported in the United States.” is factually incorrect.

Rosner, further criticises the study in claiming that one citation of adverse events was for nothing more than for mid-back soreness and irritability. A reaction to manipulation such as this may be considered trivial but nonetheless it is still an adverse event. Rosner also states that one child who suffered from a period of extended crying was not even manipulated and was assigned to a placebo group. My reading of the article reveals that indeed the child was assigned to the placebo group but was then transferred to the treatment group and after the first treatment session the parent withdrew the child from further treatment due to excessive crying.¹¹

Dr. Rosner is also correct when he states that one of the studies cited in Vohra et al¹² on adverse events from delayed diagnosis was in fact a study on the direct consequences of manipulation. The case involved a 10-year-old boy who suffered headache and nausea after chiropractic cervical manipulation but Vohra et al erroneously reported the incident as a 10-year old female who lost consciousness in their summary of direct adverse events but then cited this paper in the text as an indirect adverse event.

Of concern is the fact that the authors uncovered 20 cases of indirect adverse events resulting from delayed diagnosis and/or inappropriate provision of spinal manipulation. The evidence for these cases is extremely weak in that two of the studies^13,14 are commentaries on anecdotal case reports and the third study is case report contained in a book entitled “At your own risk: The case against chiropractic”, which is obviously an anti-chiropractic publication. However, in my experience too many chiropractors focus their attention on finding the elusive “subluxation” rather than seeking a medical diagnosis for the patient’s symptoms, which occasionally is to the patient’s expense.

The Vohra study has significant shortcomings in that there are factual errors, incorrect referencing and much of the evidence appears to be anecdotal. It deserves constructive criticism but the response from Dr. Rosner seems to be a knee-jerk reaction, which is ill-conceived and flawed.

One must, at best be naïve and at worst ignorant, to believe that adverse events do not occur with manipulation in children and those events are most probably, like adverse events in the adult population, underreported.

It is with constant amazement that I see certain elements of the chiropractic profession, whom I would term the blind faithful, latch on to any skerrick of research that supports their cause yet dismiss with distain any research that challenges their belief system. The question of safety in cervical manipulation, whether it be for children or adults has not been satisfactorily answered. You can be assured that criticism over the risk/benefit of cervical manipulation will continue, from those within and outside the profession, and it behoves a maturing profession to demonstrate with good science that it is both safe and effective. To say “it works” because that’s what I believe is no longer good enough.

Finally if you think that this is just another article of “chiro bashing” it must be remembered that one of the authors, Dr. Kim Humphries, is a chiropractor and Dean of Research at Canadian Memorial College of Chiropractic.

References:

1. Vohra s, Bradley CJ, Cramer K, Humphries K. Adverse events associated with pediatric spinal manipulation: A systematic review. J Pediatrics 2007; 119:275-83.
2. Reuters Fri Jan 12, 2007 2:36pm Spinal manipulation may not be safe for children. http://today.reuters.com/news/articlenews.
3. Rosner A. FCER responds to pediatrics article. www.fcer.org./html/News/pediatrics.htm
4. Budgell BS. Spinal manipulative therapy and visceral disorder. Chiro J Aust. 1999; 29:123-8.
5. Reed WR, Beavers S, Rddy SK, Kern G. Chiropractic management of primary nocturnal enuresis. J. Manip Physiol Ther 1994; 17:596-600.
6. Cote P, Mierau D. Chiropractic management of primary nocturnal enuresis. J Manip Physiol Ther 1995; 18:184-5.
7. Leboeuf C, Brown P, Herman A, Leembruggen K, Walton D, Crisp TC. Chiropractic care of children with nocturnal enuresis: a prospective outcome study. J Manip Physiol Ther 1991; 14:110-5.
8. Glazener CM, Evans JH, Cheuk DK. Complimentary and miscellaneous interventions for nocturnal enuresis in children. Cochrane Database Systematic Review. 2005; 18(2):CD005230
9. Rosenfeld RM, Kay D. Natural history of untreated otitis media. Layngoscope 2003; 113:164-57.
10. Reggars J. Infantile colic: The evidence base for spinal manipulation. COCA News Sept 2005. http://www.coca.com.au/newsletter/2005/sep0513a.htm.
11. Sawyer et al. A feasibility study of chiropractic spinal manipulation versus sham spinal manipulation for chronic otitis media with effusion in children. J Manip Pysiol Ther 1999; 22;292-8.
12. Klougart N, Leboeuf-Yde C, Rasmussen LR. Safety in chiropractic practice. Part II: treatment to the upper neck and the rate of cerebrovascular incidents. J Manip Physiol Ther 1996; 19:563-9.
13. Turow VD. Chiropractic for children. Arch Pediatr Adolesc Med. 1997; 151:527-8.
14. Nickerson HJ, Silberman TL, Theye FW, Rushig DA. Chiropractic manipulation in children. J Pediatr. 1992; 121:172.
15. Smith RL. At Your Own Risk: The Case Against Chiropractic. New York, NY: Simon & Schuster; 1969.