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Chiropractic manipulation for non-spinal pain – a
systematic review
Edzard Ernst
Joint manipulation is frequently used by chiropractors,
osteopaths, physicians, physiotherapists and other healthcare professionals to
treat a wide range of conditions. Even though the domain of chiropractic
manipulation is spinal pain, it is frequently also used for non-spinal
syndromes. Recent survey data from the US and Canada, for instance, show that 6%
of all patients seen by chiropractors have non-musculoskeletal
problems.1 An Australian survey demonstrated
that more than half of the responding chiropractors favoured the role of spinal
adjustments in the management of patients with visceral
conditions.2
The American Chiropractic Association defines manipulation
as:
‘...a passive manual
manoeuvre during which the three-joint complex is carried beyond the normal
physiological range of movement without exceeding the boundaries of anatomical
integrity. The essential characteristic is a thrust – a brief, sudden, and
carefully administered ‘impulsion’ that is given at the end of the
normal passive range of movement. The ‘dynamic thrust’ is the
defining factor, which distinguishes manipulation from other forms of manual
therapy. The thrust technique can be low or high velocity. The most common
characteristics of the adjustive dynamic thrust are a controlled force delivered
with high velocity, in a specific direction or line of drive, at a regulated
magnitude and depth. In short, manipulation is a passive dynamic thrust that
causes an audible release (cavitation) and attempts to increase the manipulated
joint’s range of
motion.’3
The one-year prevalence figures for manipulation in
representative population samples range between 10% (1988, Austria) and 33%
(1996, UK).4 In the US, the proportion of the
general population using chiropractic has doubled during the last 20
years.1 At present, there are about 50 000
chiropractors in active practice in North America, and their number has tripled
between 1970 and 1990.1 It has been estimated
that by 2010 their number will have doubled
again.5
Several authors have reviewed the evidence for spinal
manipulation or mobilisation as a treatment of spinal
pain.6–8 This paper aims at critically
evaluating the evidence for or against the effectiveness of chiropractic
manipulation as a treatment of non-spinal conditions.
MethodsThe following databases were
searched, each from their inception to February 2003: Medline, Embase, CISCOM,
Amed and The Cochrane Library. Furthermore, other experts were consulted. The
keywords used were: chiropractic, spinal manipulation, spinal adjustments,
controlled clinical trials, manual therapy, pain. The bibliographies of all
articles thus located and major chiropractic texts were screened for further
relevant papers. No language restrictions were applied.
Trials of spinal manipulation for treatment of headache/migraine have recently been submitted to a systematic review9 and were thus excluded. Non-randomised studies, trials of disease prevention, studies of conditions not related to pain management,10,11 clinical trials of mobilisation (as distinct from manipulation), and studies in which the therapists were not chiropractors were also excluded.9,12–15 The last exclusion was deemed appropriate because the chiropractic approach differs profoundly from that of other manual therapists (‘The ‘dynamic thrust’ is the defining factor, which distinguishes manipulation from other forms of manual therapy.’)3 While manipulation usually involves high-velocity thrusts (see above), mobilisation ‘includes any manual therapy directed at joint dysfunction that does not involve a high velocity thrust’.16 All trials meeting the above-mentioned criteria were read in full. Information on trial methodology, patient population, treatment schedule, outcome measures, follow up and results was validated and extracted by the current author in a standardised way (Table 1, click here to view). Methodological quality was assessed by two independent evaluators using the Jadad score,17 which ranges between a minimum of 0 and a maximum of 5. It is a validated measure for methodological quality of clinical trials based on the absence or presence of design features such as randomisation, double blinding, description of withdrawals or dropouts, etc. Statistical pooling (ie, meta-analysis) of the data was anticipated but turned out to be impossible, mainly because of the heterogeneity of the primary studies. ResultsEight publications met the inclusion
criteria.18–25 Their methodological
quality ranged from poor19 to
excellent.22,24,25 Key data from all studies
are summarised in Table 1 (click here to
view).
Kokjohn et al conducted a randomised controlled trial (RCT)
with 45 women suffering from primary
dysmenorrhoea.18 They were treated either with
high-velocity, short-lever, low-amplitude thrusts to all clinically relevant
vertebral levels or with a sham intervention consisting of thrusts at an
irrelevant level. The study was aimed at determining acute effects only and thus
only one treatment session took place. Abdominal pain was measured with a visual
analogue scale and menstrual distress with the Menstrual Distress Questionnaire.
In addition, levels of prostaglandin metabolites were quantified in the
peripheral blood. The results show a remarkable drop of prostaglandin levels in
both groups. Inter-group comparisons show that pain and distress were alleviated
significantly more in the experimental compared with the control
group.
Blunt et al conducted a cross-over study including 21
patients with fibromyalgia.19 These patients
were treated for four weeks with spinal manipulation, soft-tissue manipulations
and stretching. During the control phase, no such treatment was applied.
Medication was similar in both phases and was continued unchanged throughout.
The authors noted significant improvements in pain and range of motion when
comparing pre-manipulation and post-manipulation measurements. No inter-group
comparisons were made and the study design allowed no control of placebo
effects. These and other methodological weaknesses render this pilot study
uninterpretable in terms of therapeutic efficacy.
Davis and colleagues compared oral ibuprofen at decreasing
doses (800 mg three times a day to twice daily) with a series of manipulations
of the cervical spine and the upper extremities as a treatment for carpal tunnel
syndrome.20 The study included 91 patients and
was evaluator blind. There were considerable improvements in both groups but no
statistically significant difference between them. The authors nevertheless
concluded that carpal tunnel syndrome may be treated with conservative medical
or chiropractic care.
Wiberg et al randomised 50 babies with infantile colic to
receive either oral medication (as licensed in Denmark) or three to five
sessions of spinal manipulation ‘with specific light pressure with the
fingertips’.21 The main outcome measure,
time of crying per day, improved significantly more in the experimental compared
with the control group. It should be noted, however, that the former group was
significantly younger than the latter.
Sawyer et al published a pilot study of spinal manipulation
versus sham spinal manipulation for children with otitis
media.22 The sham intervention involved manual
handling of the spine for diagnostic purposes without the high-velocity thrust
performed in the experimental group. The authors do not reveal any results that
suggest real spinal manipulation to be superior to sham treatment. They do,
however, state that controlled trials of sham spinal manipulation are
feasible.
Hondras and colleagues randomised 138 patients with
dysmenorrhoea in two groups.23 The experimental
group received spinal manipulation in the form of high-velocity, short-lever,
low-amplitude thrusts with a force greater than 750 N delivered at all
clinically relevant vertebral levels and sacroiliac joints bilaterally. The
control group received thrusts with a force of around 200 N delivered to the
left L2/3 segment, which was deemed irrelevant for the condition in question.
Treatments were administered on Day 1 of cycles 2, 3, and 4, and on Day 7 before
cycles 3 and 4. The primary outcome measure was pain measured with a visual
analogue scale. The results did not yield significant inter-group differences
between real and sham treatments.
Olafsdottir and colleagues conducted an RCT testing spinal
manipulation versus a simple sham procedure for infants suffering from typical
infantile colic pain.24 The primary outcome
measure was a verbal rating scale by parents. The results show some improvements
in both groups but do not reveal significant differences between real and sham
therapy. The authors make the following interesting point: ‘This study
emphasises the need for placebo-controlled and blinded studies when
investigating alternative methods to treat unpredictable conditions such as
infantile colic.’
Hawk et al recruited 39 women with gynaecological pelvic
pain and treated them with a series of either spinal adjustments or sham
adjustments.25 The trial was set up as a
multicentre pilot study, and the authors did not formally evaluate the results.
They did, however, comment that ‘patients in both groups were satisfied
with their care and blinding appeared to be successful. Pain Disability Index
change scores were not consistent across sites’.
DiscussionPerhaps the most important result of
this systematic review is the fact that very few RCTs exist in this area. Four
of the eight RCTs had pilot
character.18,19,22,25 The range of conditions
is large and seems arbitrary. For any single condition a maximum of two RCTs
only are available. This paucity of data limits the conclusiveness of this
systematic review but does in itself represent an important finding, not least
in relation to the widespread use of chiropractic manipulation for non-spinal
pain.1,2
Chiropractic manipulation has been tested in conditions as
diverse as fibromyalgia,19 carpal tunnel
syndrome,26,27 infantile
colic,21,24 otitis
media,22
dysmenorrhoea,23 and chronic pelvic
pain.25 There are a lack of independent
replications, and multiple weaknesses in the trial designs have to be noted.
They include small sample size, lack of follow up, lack of control for placebo
response, lack of blinding and use of non-validated outcome measures. Where
independent replications have been published they failed to confirm the
initially encouraging findings.18,21,23,24 None
of the high-quality trials (ie, those with a Jadad score of 5) yielded a
conclusively positive result. The only study that generated positive results
(ie, suggesting the superiority of manipulation over medical treatment of
infantile colics) suffered from significant methodological limitations, eg, no
control of placebo effects, no blinding, no validated outcome
measure.21 In this study, the observed effect
is of questionable clinical relevance; it scored only 3 of 5 possible points on
the Jadad score. Most importantly, a larger and more rigorous study (Jadad score
= 5) of the same indication failed to confirm the positive
result.24
The combination of paucity and often low-quality primary
data seriously limits the validity of the findings and the ability to generalise
them. Moreover, one cannot be sure that all relevant RCTs have been identified,
and the influence of publication bias is difficult to assess. In this context,
it is noteworthy that no unpublished trials were identified with the
above-mentioned search strategy. It could be argued that pilot studies should be
omitted from this review. On the other hand, one might stress that it is the
very purpose of systematic reviews to summarise evidence from even the smallest
and most preliminary trials as long as they meet the pre-defined entry
criteria.
The above evidence does not demonstrate the ineffectiveness
of chiropractic manipulation for non-spinal syndromes. The evidence does,
however, show that any claims that chiropractic manipulation might be effective
in the treatment of non-spinal syndromes are not based on data from
well-designed clinical trials. Critics of chiropractic theory would add that the
notion of a benefit from chiropractic manipulation for non-spinal problems is
scientifically implausible; in other words, there is no compelling rationale why
manual adjustment of spinal malalignment should reduce non-spinal symptoms. A
further point to bear in mind is the fact that chiropractic manipulation has
repeatedly been associated with serious
complications;28 this has obvious implications
for a risk-benefit analysis and is a further important reason for segregating
chiropractic trials for this review. The risks of spinal manipulation can be
considerable,29 while the benefits for
non-spinal conditions have yet to be demonstrated. It follows that an analysis
of risk versus benefit has to yield a negative result.
Others might argue that the popularity of chiropractic
amounts to proof of its efficacy. The frequency of chiropractic visits by the
general population has been evaluated at 100 visits per 100 person-years in the
US and 140 visits per 100 person-years in the US and
Canada.30 Six per cent of these visits are
likely to be due to non-musculoskeletal
problems.1 Interestingly, patients with such
complaints are more satisfied than other chiropractic
patients.1 The open question is whether this
level of satisfaction is due to specific or non-specific therapeutic
effects.26
An important finding of this review is that high-quality
studies (with a Jadad score of 5) of manipulation are feasible. This is not to
imply that the issue of placebos in controlled clinical trials of chiropractic
has been fully resolved. In fact, one aim of this review is to stimulate further
research into this and related areas. Rigorous RCTs should now be conducted by
those who make (and profit from) claims of efficacy. These RCTs should be
conducted patient blind and evaluator blind against a sham control intervention
in order to allow for placebo effects that have repeatedly been
demonstrated.26 Obviously, they should be of
sufficient sample size (ideally based on a proper sample-size calculation with
sufficient power avoiding type I and II errors) and employ validated outcome
measures of clinical effectiveness.
In conclusion, the notion that chiropractic manipulation is
an effective treatment of non-spinal pain syndromes is not based on conclusive
evidence. Those who make claims of effectiveness should provide the evidence to
back them up.
Author information:
Edzard Ernst, Professor of Complementary Medicine, Complementary
Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter,
UK
Correspondence:
Professor Edzard Ernst, Complementary
Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, 25
Victoria Park Road, Exeter EX2 4NT, UK. Fax: +44 1392 424989; email: Edzard.Ernst@pms.ac.uk
References:
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