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Complementary Therapies in Clinical Practice (2006) 12,83–90
A preliminary assessment of the impact of cranial
osteopathy for the relief of infantile colic
Clive Hayden
a,
, Brenda Mullinger
b
a
Churchdown Osteopaths, 102 Chosen Drive, Churchdown, Gloucestershire GL3 2QU, UK
b
Postgraduate Research Development Officer, European School of Osteopathy, Boxley House, Boxley,
Maidstone, Kent ME14 3DZ, UK
KEYWORDS
Infantile colic;
Cranial;
Osteopathic manipu-
lation;
Clinical trial;
Crying;
Effectiveness
Summary In this open, controlled, prospective study, 28 infants with colic were
randomized to either cranial osteopathic manipulation or no treatment; all were
seen once weekly for 4 weeks. Treatment was according to individual findings, and
administered by the same practitioner. Parents recorded time spent crying, sleeping
and being held/rocked on a 24-hour diary. A progressive, highly significant reduction
between weeks 1 and 4 in crying (hours/24 h) was detected (Po0:001) in treated
infants; similarly, there was a significant improvement in time spent sleeping
(Po0:002). By contrast, no significant differences were detected in these variables
for the control group. Overall decline in crying was 63% and 23%, respectively, for
treated and controls; improvement in sleeping was 11% and 2%. Treated infants also
required less parental attention than the untreated group. In conclusion, this
preliminary study suggests that cranial osteopathic treatment can benefit infants
with colic; a larger, double-blind study is warranted.
&2006 Elsevier Ltd. All rights reserved.
Introduction
Infantile colic is a common cause of paroxysmal
abdominal pains with resultant distress both to the
child and parents alike; it usually commences
between 2 and 3 weeks postnatally
1
and affects
8–40% of infants.
2,3
There are many possible
aetiological factors, including incomplete lactose
absorption
4,5
cow’s milk intolerance,
5,6
familial and
genetic factors
7,8
and dietary insults.
9
Undigested
lactose may create an osmotic gradient that
facilitates intraluminal retention of water, result-
ing in relative physiological dehydration of intest-
inal tissues, and may encourage bacterial growth
producing gas with subsequent bloating, flatulence,
borborygmi and cramp.
10,11
Stress factors in preg-
nancy, childbirth and inadequate postnatal care
may also be important determinants in the devel-
opment of infantile colic
1,12
although the exact role
of adverse environmental circumstances before and
during birth has yet to be determined.
13
ARTICLE IN PRESS
www.elsevierhealth.com/journals/ctnm
1744-3881/$ - see front matter &2006 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ctcp.2005.12.005
Corresponding author. Tel: +44 1452 714511;
fax: +44 1452 541369.
E-mail addresses: hayden695@btinternet.com (C. Hayden),
brendamullinger@eso.ac.uk (B. Mullinger).
The general lack of understanding and consensus
on its development has led to a wide variety of
treatment strategies for infantile colic, each with
its own limitations and varying degrees of relia-
bility.
2,14
As the repetitive, inconsolable bouts of
colicky crying inevitably place a stress on family
life, many parents turn to complementary thera-
pies to help their child. Cranial osteopathy has
gained a particular reputation in this regard even
though evaluation by randomized controlled trials
is lacking.
15
Osteopathic treatment consists of the diagnosis of
the musculo-skeletal strain patterns in the body,
followed by techniques to release these strains.
Specifically, the cranial osteopathic approach to
infantile colic involves the application of gentle
manual techniques to the head as well as any other
areas of the infant body that demonstrate palpably
increased ligamentous/muscular tone, or de-
creased/abnormal articular mobility. Very light
tactile pressure is applied to the affected area until
a palpable release of the relevant physical tensions
and areas of dysfunction (including parts of the
cranium) is achieved. Osteopathic treatment may
alleviate the physical and biomechanical influences
of childbirth. It is also feasible that by attempting to
reduce the distortions and twists in the musculo-
skeletal framework, improving joint mobility, and
reducing apparent muscular hypertonia in the
infant, manipulation may reduce the somatic affer-
ent load into the central nervous system.
16
The objective of this preliminary study was to
investigate the effect of cranial osteopathic ma-
nipulative treatment on the pattern of increased
crying, irritability and disturbed sleep associated
with infantile colic, as reported by the parents.
Methodology
Study design and participants
The study was a prospective, randomized, open,
controlled trial comparing cranial osteopathic ma-
nipulation with no treatment for infants suffering
from infantile colic. Infants and their parent(s) were
seen weekly over a 4-week period (total of 5 visits).
The study was pragmatic
17
; it was carried out at a
single centre with all treatments given by the same
osteopath (the principal author) following his usual
clinical practice/management. Recruitment to the
study was through health visitors (Gloucester and
Cheltenham); by referral from local GP surgeries,
osteopathic colleagues, the local National Childbirth
Trust, and by self-referral. The study protocol
conformed to the principles of the Declaration of
Helsinki
18
and was approved by the West Glouces-
tershire Local Research Ethics Committee.
Infants were eligible for the study if they were
between 1 and 12 weeks of age, had not been
previously treated osteopathically, exhibited signs
of infantile colic (see below) and there were no
signs or symptoms indicative of other disease.
Infantile colic was defined as at least 90 min of
inconsolable crying per 24 h on 5 out of the previous
7 days (as reported by the parents prior to inclusion
in the study), with normal behaviour outside of
these periods.
19
Inconsolable crying during a colic
attack was when the infants could not be com-
forted by being held, rocked or walked, or being
soothed in any way. In addition, each infant was
required to have displayed typical signs of colic:
loud gurgling noises from the abdomen (borbor-
ygmi), knees drawn up to the chest, fists clenched
and backward bending of the head or trunk.
Methods
All infants referred for the study were screened for
possible inclusion; past medical history and general
health were recorded and a routine osteopathic
assessment (gross morphology, mobility, organ
systems, mental and neurological status) was
performed. In addition, muscular and ligamentous
tone and restrictions in articulations were ex-
plored, as well as notable asymmetries of limb
orientation and development, and distortions of
the head, spine and body shape.
A written explanation of the objectives of the
study was given to each parent plus a standardized
information sheet and their written consent for the
participation of their child in the study was
obtained. They were made aware that they could
withdraw their infant from the study at any time
and also that, if randomized to the control group,
their infant would not receive any osteopathic
intervention for the duration of the study (4 weeks).
However, osteopathic treatment could be made
available, if required, at the end of that period.
Parents were then given a questionnaire about
birth details, behaviour during a colic attack,
sleeping and feeding patterns and past medical
history; this provided confirmation of the eligibility
of their infant for the study. Parents were also given
a daily diary for use during the study; on this they
recorded in every 24 h the amount of inconsolable
crying, the total time spent sleeping, and the time
the infant was being held or rocked (taken as an
indication of low-level colic). Parents were asked to
continue with bringing their infant to the clinic and
ARTICLE IN PRESS
C. Hayden, B. Mullinger84
completing the diary card even if the symptoms of
colic resolved during the 4-week period.
Treatment
Following screening, eligible infants were rando-
mized (using a random number table) into a control
and test group. All infants were brought to the
osteopathic clinic once a week for 4 weeks. Equal
time was spent with all participants/parents over
the study period. The initial visit and interview was
for an hour; infants in the control group were given
a brief examination with minimal touch, whereas
following their examination those in the treated
group received cranial osteopathic manipulative
therapy as required (week 0). Treatment was
individualized, according to clinical findings, and
involved standard cranial osteopathic techniques
20
until a palpable release of tensions and dysfunction
was achieved. At the four subsequent half-hourly
sessions (weeks 1–4), infants in the control group
received no physical intervention; osteopathic
manipulation in the treatment group was depen-
dent on findings at each visit. All parents were able
to ask questions, discuss their problems and receive
counselling from the osteopath at each visit.
Statistical analysis
The two main endpoints in this study were the
mean number of hours/24 h spent with colicky
crying and the mean number of hours/24 h spent
sleeping. For each infant, the difference in these
parameters (daily average over the previous week)
from weeks 1 to 4 was calculated and the mean
change for each group separately was tested for
significance using Student’s t-test (paired). In
addition, the difference between the means for
the two groups was compared using a two-sample
t-test. The percentage change in hours of crying
(per 24 h) between week 1 and each subsequent
visit was calculated and plotted graphically; a
similar analysis was performed for the hours spent
sleeping. Regression and correlation analyses were
used to explore the relationship between crying
time and sleeping time.
Results
Patient population
Forty-four infants were screened; of these, 28
(64%) fulfilled the inclusion criteria and were
randomized to treatment or control (Fig. 1). The
demographic characteristics of infants in the
treated group were similar to those in the control
group with respect to those factors considered
likely to affect the severity or outcome of infant
colic (Table 1). Males outnumbered females in a
ratio of 3:1 overall, but with no significant
difference between the control and test groups
(w2¼3:39;P40:05).
Parents confirmed, at the initial visit, that the
‘colic cry’ differed from other crying and was
accompanied by gurgling sounds with signs of
abdominal discomfort and irritability, but none of
the infants showed any signs of failure to thrive. At
study commencement, the mean sleeping time of
all infants was estimated at 11.9 h/24 h; parents
frequently noted that sleep was often very restless.
Response to treatment
All 26 infants who completed the study remained
healthy throughout, with normal development. In
the treatment group all 14 infants improved
following cranial osteopathic manipulation; 4
(29%) required no further treatment after week 2
and a further 6 (43%) did not require any further
treatment after week 3. All continued in the study.
The remaining 4 (29%) infants in the treated group
still showed mild levels of colic at the end of the
study.
By comparison, only 2 (14%) infants in the control
group showed a spontaneous improvement within
the first 2 weeks of the study. The symptoms of
colic worsened for two infants in the control group
and each was admitted to hospital; one withdrew
after 22 days in the study because of developing
pneumonia, and the other after day 20 because of
the deteriorating colic condition (there were no
other study withdrawals). Of the remaining 10
ARTICLE IN PRESS
Screened
N = 44
Met entry criteria
N = 28
Treated
N = 14
Control
N = 14
4 week follow up
N = 14
4 week follow up
N = 12
Withdrawals
N = 2
Figure 1 Patient recruitment.
Cranial osteopathy for the relief of infantile colic 85
infants, 1 (10%) had improved by week 3, and a
further 4 (40%) by week 4; however, a continuing
pattern of colic behaviour was present in 5 (50%) at
the end of the study.
The daily diary was completed without difficulty by
most parents. The one exception was a mother with
an infant in the treated group who, from week 2,
recorded only her infant’s sleeping and awake time.
Crying patterns
The mean hours of colic crying per 24 h of the
babies who underwent osteopathic treatment
showed a progressive reduction at weeks 2, 3 and
4(Table 2) reaching a significant reduction from
week 1 of 1.5 h (70.32 SEM) by week 4 (Po0:001).
In the control group there was an increase at week
2 in hours spent crying, followed by a slight decline
to week 4; the difference of 0.5 h from weeks 1 to 4
was not significant (P40:07). The difference
between the two groups in the mean reduction in
crying time of 1.0 (95% confidence interval: 0.14,
2.19) hours/24 h was found to be statistically
significant (Po0:02) in favour of the treated group.
The overall reduction in crying per 24 h from
weeks 1 to 4 was 63% for the treatment group and
23% for the control group (Fig. 2).
ARTICLE IN PRESS
Table 1 Characteristics of infants randomized into the study.
Treated group (n¼14) Control group (n¼14)
Males/females 13:1 9:5
Age at study entry (days): Mean7SEM and (range) 46.475.4 (12–83) 44.575.0 (10–82)
Gestational age at delivery (days): mean7SEM
and (range)
27771.3 (266–280) 27573.4 (249–294) (n¼13)
Feeding
Breast fed 10 7
Bottle fed 1 4
Mixed feeding 3 3
Delivery
Normal vaginal delivery 11 13
Assisted delivery 2 4
Emergency Caesarean section 3 1
Elective Caesarean section 0 0
Presentation on delivery
Occiput posterior 5 6
Occiput anterior 7 5
Breech 0 0
Not known 2 3
Nuchal cord 3 1
Foetal distress 7 6
Table 2 Mean (7SEM) hours spent crying (colicky cry) and sleeping per 24 h.
Week 1 Week 2 Week 3 Week 4 Change week 1
to week 4
Crying
Treated (n¼14)
2.39 (70.36) 1.89 (70.35) 1.67 (70.35) 0.89 (70.28) 1.5 (70.32)**
Control (n¼14)
y
2.06 (70.24) 2.22 (70.35) 1.87 (70.31) 1.56 (70.27) 0.5 (70.29)
Sleeping
Treated (n¼14) 11.55 (70.58) 12.51 (70.55) 12.55 (70.66) 12.90 (70.58) 1.35 (70.38)***
Control (n¼14)
y
11.86 (70.66) 11.79 (70.64) 12.17 (70.68) 12.04 (70.79) 0.18 (70.30)
**Po0.001.
***Po0.002.
n¼13 from week 2 (incomplete diary entries).
y
n¼13 at week 3, n¼12 at week 4 (withdrawals).
C. Hayden, B. Mullinger86
Sleeping patterns
There was a progressive improvement in the
amount of restful sleep gained over the 4-week
period for babies who underwent cranial osteo-
pathic treatment; only a minimal improvement was
observed in the control group (Table 2). The mean
increase of 1.3570.38 h in the hours/24 h spent
sleeping between week 1 and 4 was highly
significant for the treated group (Po0:002). By
comparison the control group showed a mean
difference of only 0.1870.30 h which was not
significant (P40:3). The difference between the
treated and control groups of 1.17 (95% confidence
interval: 0.29, 2.27) hours/24 h in the mean
increase in sleeping time was significant
(Po0:05). The overall improvement in sleeping
time by week 4 was 11% for infants in the treated
group and less than 2% in the control group (Fig. 3).
Further statistical analysis for the crying time
and sleeping time per 24 h for both groups over the
4-week period revealed that in the osteopathically
treated group these parameters showed a recipro-
cal correlation (r¼0:432;Po0:001 highly signifi-
cant). No correlation between sleeping and crying
over the period of study was detected for the
control group (r¼0:220;P40:125) (Fig. 4).
Parental involvement
Parents of the treated infants recorded holding and
rocking their infants for a significantly less time per
24 h than those with infants in the control group.
The mean difference between week 1 and 4 for the
treated group was 1.3 h (Po0:015) and 2.0 h for the
control group (P40:05).
Discussion
This study provides evidence to suggest a beneficial
effect of cranial osteopathic manipulation for
infants suffering from infantile colic. A highly
significant reduction in colicky crying and a
similarly significant increase in the sleeping period
were observed in those infants who received
active treatment. By comparison, there were no
ARTICLE IN PRESS
0
1
2
3
4
5
6
6 8 10 12 14 16 18
Mean Hours of Crying per Day
Control Group
Treated Group
Control Group Trend
Treated Group Trend
Mean Hours of Sleeping per Day
Figure 4 Relationships between mean weekly hours spent crying and sleeping/24 h over the 4-week study period;
scatter plot (and trend lines) for individual infants in the treated and control groups.
-5
0
5
10
15
Week
Percentage change in sleeping time
1234
Treated Group Control Group
Figure 3 Mean percentage change in hours/24 h spent
sleeping for treated and control groups.
-80
-60
-40
-20
0
20
Week
Percentage change in crying time
1234
Treated Group Control Group
Figure 2 Mean percentage change in hours/24 h spent
crying for treated and control groups.
Cranial osteopathy for the relief of infantile colic 87
significant changes in daily crying or sleeping
patterns over the 4-week study for infants in the
control group. These differences in the main study
variables were further reinforced by measurement
of the time spent being rocked or held; those who
were treated osteopathically again showed a
significant improvement compared with infants
who remained untreated.
This is the first account, to our knowledge, of a
randomized trial to investigate treatment effects
following cranial osteopathic manipulation for
infantile colic. There is limited information in the
literature on chiropractic spinal manipulation of
colicky infants; two randomized controlled trials
reported positive results
21,22
whereas a third
concluded that chiropractic offers no greater
efficacy than placebo.
23
A strong placebo effect
(following parental counselling) or the number of
treatments given have been postulated to explain
these differences.
24,25
The unsettled behaviour observed in this cohort
of infants may have been associated with trauma
experienced during a difficult delivery; foetal
distress was noted in 50% of the treated group,
and 39% of the control group, whilst 21% and 7% of
each group, respectively, had been delivered by
emergency Caesarean section. It has been sug-
gested
1,12
that the factors associated with a
significantly increased occurrence of infantile colic
were a ‘psychological’ complication of pregnancy, a
bad experience of pregnancy or labour, and a
sibling with a history of infantile colic. However, no
significant association with true obstetric compli-
cations was found in these studies, although an
increased risk of colic was observed following both
forceps deliveries and epidural anaesthesia.
It may be argued that any delivery requiring
surgical or assisted intervention is stressful for the
infant—a ‘psychological’ complication of a physi-
cally demanding process—‘‘in which strong pres-
sures are exerted onto the foetal head and
body’’.
26
The association of colic with physically and
psychologically traumatic deliveries may well cause
lingering stress effects in the infant; the effects of
stress on increasing gut motility and therefore
decreasing the time taken for lactose to be
digested in the stomach are widely acknowledged.
It also remains a possibility that the physical
tension palpable in affected infants may be
secondary to the pain and discomfort associated
with the colic condition itself.
The wide variation in the reported frequency for
colicky crying (8–40%) underlines the difficulty in
defining the nature and severity of colic.
3,14,19,27–29
Uncontrollable colic crying with concurrent abdom-
inal discomfort has been shown to differ from
normal crying
9,29
and appears to be the most
common variable measured.
30–32
This study
adopted the definition of colic proposed by Klou-
gart et al.
19
; by also recording other outcome
variables (sleep, and time spent comforting the
infant) we gained a wider picture of the colicky
infant. It is possible that the uncomfortable,
writhing infant who does not sleep well and needs
constant parental attention is experiencing a mild
level of colic. A small proportion (about one-third)
of infants in the treated group, although markedly
improved at week 4, fell into this category. These
infants may have benefited from a longer period of
treatment, and future studies might consider this
possibility. Alternatively, together with some of the
infants in the control group with continuing colic at
the end of the study (5, plus one withdrawal due to
colic: 43%) they may represent a sub-group of
infants with lactose intolerance. This is in line with
the reported background level of lactose intoler-
ance in the community; Webster
33
noted that 1 in 4
(24%) of a population of 137 children whose ages
ranged from 6 to 18 years were found to be lactose
intolerant.
The duration and severity of the colic are related
to the age of onset, that is, the earlier the
symptoms start the more severe and long lasting
they are likely to be.
8
In our study some infants
were included from 10-days old, whilst others were
nearer 12 weeks of age. As the peak incidence of
colic appears to be 6–8 weeks, and the condition
shows a natural history of improvement over time,
a degree of variability in response to the treatment
might be expected. However, the study design did
not allow for establishing the normal pattern of
colic for each infant prior to randomization. Use of
a daily diary for assessment of the infant over 3 or
more days before inclusion in the study is recom-
mended.
The positive trends observed in our preliminary
study warrant further investigation utilizing a
double-blind technique. Our study was not double
blind because the medical advice offered when it
was being designed opposed any ‘sham’ treatment
for a control group and advised that the infants
should not be removed from their parents. The
placebo effects of simply handling the infants,
therefore, could not be addressed by the chosen
study design. The unblinded study may have
generated additional stress in parents of infants in
the control group, resulting in negative effects on
the infant; this could possibly explain the apparent
skewing of the data at week 2 for the crying and
sleeping variables (Figs. 2 and 3) in this group. By
contrast, awareness of the treatment group may
ARTICLE IN PRESS
C. Hayden, B. Mullinger88
have positively influenced parental recording of
colicky symptoms for infants in the treated group.
However, it is interesting that the improvement
noted by parents of treated infants was also
detected osteopathically: no further manipulation
was found to be necessary after week 3 for 72% of
this group. Also, the relationship between maternal
stress and colic remains a matter for debate.
14
Future study designs will require further considera-
tion of both the placebo and blinding issues.
One reason for conducting this preliminary
investigation was to explore the feasibility of
obtaining parental consent and commitment for a
study involving an untreated control group. Even
though some parents expressed disappointment at
their infant’s allocation, none withdrew from the
study because of this. This finding may relate to a
desire to alleviate the stress on family life
associated with infantile colic and the current lack
of other satisfactory treatment modalities. Based
on personal experience and conversations with
health visitors, it seems that infants referred to
osteopaths are generally those showing moderate-
to-severe symptoms unresponsive to orthodox
medical management.
The fact that only one practitioner delivered all
treatments is both a strength and a weakness of
this study. The advantage of consistency in osteo-
pathic diagnosis, manipulative therapy and assess-
ment of treatment outcome must be weighed
against the uncertainty of wider applicability. A
larger multi-centred study is currently being con-
sidered—and is both feasible and desirable.
The results obtained in our study lend support to
the thesis that cranial osteopathy can help alle-
viate the abnormal behavioural symptoms
associated with infantile colic. The progressive
and sustained improvement in crying patterns
observed in the treated group may have resulted
from a normalization in musculo-skeletal tone,
which was possibly achieved by osteopathic manip-
ulation. Also, the treatment strategy may have
resulted in a reduction of the somato-visceral
neurological load. The small reduction in crying
time observed for infants in the control group may
have been associated with the normal growth and
development of the infant and the natural pro-
gressive history of this condition of improvement
over time.
In conclusion, our preliminary study suggests that
the net result of cranial osteopathic treatment is a
more relaxed infant who cries significantly less,
sleeps significantly longer and more restfully, and
needs less comforting and placating. This at least is
the parents’ perception. The psycho-social con-
sequences are implicit, with the parents benefiting
from the improved state of the child and the
quality of the parenting thus being enhanced.
Acknowledgements
Our thanks go to the European School of Osteo-
pathy, Maidstone and, in particular, the late Don
Prashad for his guidance; to S.P. Patel, University of
Greenwich, for her statistical input and to Liz
Hayden, DO, for her encouragement and knowl-
edgeable support. Thanks also to the GPs, Health
Visitors, the National Childbirth Trust, and osteo-
paths in Gloucester and Cheltenham for referring
patients for this study.
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