ORIGINAL ARTICLE

Does the addition of visceral manipulation alter outcomes for

patients with low back pain? A randomized placebo
controlled trial
J. Panagopoulos1, M.J. Hancock1, P. Ferreira2, J. Hush1, P. Petocz3
1 Faculty of Human Sciences, Macquarie University, Sydney, Australia
2 Faculty of Health Sciences, University of Sydney, Australia
3 Department of Statistics, Macquarie University, Sydney, Australia

Correspondence
John Panagopoulos
E-mail:
john.panagopoulos@students.mq.edu.au
Funding sources
None.
Conicts of interest
None declared.
Accepted for publication
23 September 2014
doi:10.1002/ejp.614

Abstract
Background: This study aimed to investigate whether the addition of
visceral manipulation, to a standard physiotherapy algorithm, improved
outcomes in patients with low back pain.
Methods: Sixty-four patients with low back pain who presented for treatment at a private physiotherapy clinic were randomized to one of two
groups: standard physiotherapy plus visceral manipulation (n = 32) or
standard physiotherapy plus placebo visceral manipulation (n = 32). The
primary outcome was pain (measured with the 010 Numerical Pain Rating
Scale) at 6 weeks. Secondary outcomes were pain at 2 and 52 weeks,
disability (measured with the Roland-Morris Disability Questionnaire) at 2,
6 and 52 weeks and function (measured with the Patient-Specific Functional Scale) at 2, 6 and 52 weeks. This trial was registered with the Australia
and New Zealand Clinical Trials Registry (ACTRN12611000757910).
Results: The addition of visceral manipulation did not affect the primary
outcome of pain at 6 weeks (0.12, 95% CI = 1.45 to 1.21). There were
no significant between-group differences for the secondary outcomes of
pain at 2 weeks or disability and function at 2, 6 or 52 weeks. The group
receiving addition of visceral manipulation had less pain than the placebo
group at 52 weeks (mean 1.57, 95% CI = 0.32 to 2.82). Participants were
adequately blinded to group status and there were no adverse effects
reported in either group.
Conclusions: Our study suggests that visceral manipulation in addition to
standard care is not effective in changing short-term outcomes but may
produce clinically worthwhile improvements in pain at 1 year.

1. Background
Despite the large number of randomized controlled
trials investigating interventions for low back pain
(LBP), recommended interventions produce only
small effects (Keller et al., 2007). It is possible that
outcomes could be improved by combining current
interventions or by the addition of new therapies.
Visceral manipulation is a manual therapy technique aimed at treating motion abnormalities of the
internal organs (Barral, 2005; Vleminckx, 2006).
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Although visceral manipulation is not taught in basic

physiotherapy training, training in this treatment
technique is being sought out by many physiotherapists and health practitioners in post-graduate workshops. However, there is paucity of research into the
efficacy of this approach.
There is preliminary evidence that visceral manipulation may be effective for treating LBP. A recent clinical series demonstrated improved symptoms following
a specific visceral manipulation technique aimed at
mobilizing the kidneys in people with nonspecific LBP
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Does visceral manipulation alter low back pain outcomes?

Whats already known about this topic?

Visceral manipulation has been used for over a
decade in the treatment of low back pain, but its
efficacy remains untested.
What does this study add?
This study demonstrates that the addition of visceral manipulation to a standard physiotherapy
treatment algorithm improves long-term but not
short-term pain.

(Tozzi et al., 2012). Another within-subject, repeated

measures study demonstrated immediate lumbar
pressure/pain threshold reduction in asymptomatic
subjects following visceral manipulation techniques
(McSweeney et al., 2012).
The rationale for this therapeutic approach is that visceral disorders could potentially trigger or exacerbate LBP
symptoms in the presence of impaired movement
between internal organs and their supportive tissues. This
could manifest as LBP via two possible mechanisms: visceral referred pain and central sensitization.
The mechanism by which visceral pain causes referral to somatic structures could occur by neural convergence, whereby sympathetic afferent nerves that
convey signals from the viscera converge with somatic
nerves in the dorsal horn. Due to the low proportion
of visceral to somatic afferents entering the dorsal
horn (Cervero, 2000) and because activation of certain
visceral receptors does not induce conscious perception (Cervero, 2009), visceral nociceptive input can be
misinterpreted as arising from somatic structures.
Activation of visceral nociceptors can result in
central sensitization. These nociceptors can be stimulated by an altered gut environment or by altered
gastrointestinal/urinary motility (Cervero, 2009).
Hence, small variations around the visceral sensory
receptors can evoke peripheral hypersensitivity
(Cervero, 1995). Even a low level of peripheral input
can cause increased activity of projection neurons in
the spinal cord and can dynamically maintain this
central activation (Woolf, 2011). Central sensitization
can result in normal sensory stimuli, such as mechanical touch, being experienced as pain (Woolf, 2011).
The mechanisms by which visceral manipulation
may have an effect on pain are not yet understood.
One hypothesis is that by specific manual treatment of
the supportive fascia of the internal cavities of the
trunk, visceral manipulation modulates visceral nociceptive signalling (Vleminckx, 2006), reducing excessive visceral nociceptive input entering the spinal cord
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J. Panagopoulos et al.

and allowing hypersensitive central neurons to return

to a normal state of excitation (Woolf, 2011).
Therefore, it is possible that visceral disorders contribute to the development and continuation of LBP in
some patients and that standard therapies which do
not directly target the viscera (and surrounding fascia)
could neglect a potential pain-producing component.
The efficacy of visceral manipulation for LBP has not
yet been evaluated in a randomized controlled trial.
The aim of this study was to investigate whether the
addition of visceral manipulation to standard physiotherapy care for LBP improves pain, disability and
functional outcomes.

2. Methods
2.1 Study design
The study design was a randomized placebo controlled trial
with blinded follow-up. Ethical approval for this study was
received from the University of Sydney Human Research
Ethics Committee. This study was registered with the Australia and New Zealand Clinical Trials Registry
(ACTRN12611000757910) and the study protocol was published (Panagopoulos et al., 2013).

2.2 Study population/recruitment

Consecutive patients who presented with LBP to a private
physiotherapy clinic in Sydney, Australia were screened for
eligibility. Potential participants who met the inclusion criteria were invited to participate in the trial and provided
written consent. To be eligible for the trial, participants were
required to meet all of the following criteria as assessed by
the treating physiotherapist: primary complaint of pain in
the area extending from the 12th rib to the buttock crease
(this may or may not be accompanied by pain in the leg or
other spinal areas); LBP symptoms which have a score of
>2/10 on the 010 Numerical Pain Rating Scale (NPRS)
(Pengel et al., 2004); aged 1880; no known or suspected
serious spinal pathology (e.g., metastatic, inflammatory or
infective diseases of the spine, cauda equina syndrome, canal
stenosis, spinal fracture); no nerve root compromise evidenced by at least two of the following (1) myotomal weakness, (2) dermatomal or widespread sensory loss, (3) hypoor hyperreflexia of the lower limb reflexes; no spinal surgery
within the preceding 6 months; no visceral surgery within
the preceding 6 months; no vascular abnormality such as
abdominal aortic aneurysms; not currently receiving chiropractic, osteopathic or other physical therapy; not pregnant
or suspect being pregnant; not currently in an acute inflammatory phase of known gastrointestinal or urinary diseases
(such as cholecystitis, renal calculi, peritonitis, appendicitis);
not currently taking medications that significantly alter gut
motility; not currently taking medications (such as oral cor-

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Does visceral manipulation alter low back pain outcomes?

ticosteroids which are known to increase the risk of intestinal perforation); no known gastrointestinal disease that
associates with a risk of intestinal perforation (e.g. Crohns
disease, diverticular disease, peptic ulcer disease); not taking
anti-platelet medications such as warfarin.

2.3 Baseline measures and randomization

Participants completed baseline data immediately prior
to being randomized to a treatment arm of the study
(Fig. 1). A total of 98 patients were eligible and 34 were
excluded as they did not fit the inclusion criteria
(Fig. 1). Of these excluded patients, 18 chose not to
participate, 12 had a pain rating which was too low at
baseline, two were pregnant, one had had previous
lumbar surgery and one patient was over 80 years of
age (Fig. 1). At initial assessment, demographic data
and the following baseline measures were collected:
pain, measured with the 010 NPRS (Pengel et al.,
2004), where 0 = no pain and 10 = pain as bad as it
could be; disability, measured with the 024 RolandMorris Disability Scale (Roland and Morris, 1983),
where 0 = no disability and 24 = severe disability; function, measured with the 010 Patient-Specific Functional Scale (Stratford et al., 1995), in which the
patient nominates three important activities which are

limited by their pain and rates their ability to perform

them on a Likert scale ranging from 0 (unable to
perform the activity) to 10 (able to perform the activity
at pre-injury level). The scores are summed and averaged producing a score out of 10; presence of
gastrointestinal/urinary/reproductive symptoms was
assessed by asking participants if they suffer from bloating, diarrhoea, constipation, period pain, cramping,
food sensitivity or reflux. This variable of visceral symptomatology allowed researchers to determine whether
patients with obvious visceral symptoms were randomized equally to both treatment arms of the study.
A researcher not involved in data collection or
analysis developed a randomization schedule using
Excel to generate 64 sequentially numbers, which
were concealed in sealed, opaque randomization
envelopes. These envelopes contained a paper with
words VM or placebo. After baseline data had been
collected, the treating physiotherapist opened the next
randomization envelope and allocated the participant
according to the randomization schedule (Fig. 1).

2.4 Clinical assessment

Participants were assessed by one of two experienced
musculoskeletal physiotherapists. Both physiothera-

98 Eligible LBP patients attend for physiotherapy assessment and treatment

34 patients excluded
18 chose not to participate
12 pain rating too low
2 pregnant
1 previous lumbar surgery

64 participants randomized

1 >80 years of age

32 Placebo group

32 Visceral manipulation group

standard physiotherapy + sham visceral

manipulation

standard physiotherapy + real visceral

manipulaion

31 followed-up at 2 weeks (97%)

32 followed-up at 2 weeks (100%)

30 followed-up at 6 weeks (94%)

32 followed-up at 6 weeks (100%)

28 followed-up at 52 weeks (88%)

31 followed-up at 52 weeks (97%)

Figure 1 Study ow diagram.

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Does visceral manipulation alter low back pain outcomes?

pists had concluded post-graduate intensive practical

and coursework training in visceral manipulation and
had between 6 and 10 years of clinical experience in
the use of visceral manipulation. All participants
received a standardized assessment involving active
movement testing, passive intervertebral motion
testing, palpation, neural tension testing and functional stability testing. Participants also received palpation testing of their visceral system to assess which
visceral structures may be involved in the participants
clinical presentation. This palpation testing involved
the gastrointestinal, urinary, respiratory, reproductive
and cardiovascular systems as described in detail in
Barral (2005). In brief, the physiotherapist placed his
hands on the anterior part of the subjects body
and assessed organ motility and visceral ligament
mobility. For participants allocated to placebo visceral
manipulation, these findings were noted but not used
in treatment.

2.5 Treatments
Participants in both groups received the same standardized physical examination and standard care. The
two treating physiotherapists treated both control and
intervention patients. As per LBP guidelines, all participants received current evidence-based advice
focusing on remaining active (Koes et al., 2010).
Participants received manual therapy, exercise therapy
(lumbar muscle re-training and functional exercise
prescription) and massage, as required by the treating
physiotherapist. To facilitate lumbar muscle
re-training, real-time ultrasound guided imaging was
used to provide visual feedback and education.
All participants were treated one to two times per
week for a minimum of one week and a maximum of
12 treatments over 6 weeks. The number of treatment
sessions was based on the rate of participants
symptom reduction. Following the 6-week period,
treatment was continued if participants felt their treatment or rehabilitation goals had not been met. Participants continued to receive treatment as per their
group allocation and remained blinded. For both
groups, initial treatment sessions lasted for approximately 40 min and follow-up sessions lasted approximately 2530 min.
In order to ensure compliance and monitor treatments delivered in the study, therapists kept a record
of the number of times the patient attended physiotherapy and recorded details of the treatment including the techniques used.
The interventions for each group were as follows:
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2.5.1 Standard care plus active visceral

manipulation group
In addition to standard care (as described above), any
fascial restrictions were treated using specific visceral
manipulation techniques (Barral, 2005; Tozzi et al.,
2012). This took approximately 510 min and
involved light or deep manual fascial releases and specific organ mobilizations in the thoracic, subdiaphragmatic, abdominal and pelvic areas as appropriate
(Barral, 2005).
2.5.2 Standard care plus placebo visceral
manipulation group
Participants were treated with standard care as defined
above. Participants also received a placebo visceral
treatment which involved approximately 5 min of
sham treatment aimed around the abdominal area.
This involved light touch and no intention on the part
of the physiotherapist to impart any therapeutic technique. This placebo therapy was performed on areas of
the abdomen not involved in a mechanical, functional
or neurological sense to any visceral issues present.
The placebo technique was pilot tested on experienced
physiotherapists (who had no prior experience of visceral manipulation) prior to starting the trial. The
physiotherapists were unable to distinguish between
the placebo and real visceral manipulation.

2.6 Outcome measures

Measures of outcome were recorded by an assessor
blinded to group allocation. Outcomes were recorded at
baseline, 2, 6 and 52 weeks after commencement of
treatment. If the participant had ceased treatment, the
outcome measures were collected by a blinded assessor
over the phone or by email. At 6 weeks, participants
were asked a treatment credibility question regarding
which additional treatment they thought they received
(real or placebo treatment). This was performed to
assess if participant blinding was successful.
2.6.1 Primary outcome
The primary outcome was pain intensity (010 NPRS)
at 6 weeks as it was hypothesized to be the time when
the intervention may have largest effect.
2.6.2 Secondary outcomes
The secondary outcomes were pain intensity (010
NRPS) at 2 and 52 weeks, function and disability at 2,
6 and 52 weeks.
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Does visceral manipulation alter low back pain outcomes?

Table 1 Effects of visceral manipulation compared with control.

Visceral manipulation

Control

Adjusted treatment
differences (95% condence
interval)

3.06 (2.08)
2.31 (1.99)
1.52 (1.65)

3.74 (2.25)
2.33 (2.22)
3.21 (2.27)

0.55 (0.65 to 1.75)

0.12 (1.45 to 1.21)
1.57 (0.32 to 2.82)

0.362
0.858
0.015

5.78 (5.40)
3.00 (2.96)
2.06 (3.56)

6.26 (5.35)
3.10 (3.98)
3.50 (3.61)

0.86 (3.33 to 1.58)

1.20 (4.18 to 1.75)
0.11 (2.86 to 3.07)

0.479
0.418
0.942

6.10 (2.13)
7.70 (1.81)
8.43 (1.76)

6.15 (1.95)
7.51 (1.86)
7.55 (1.82)

0.81 (0.33 to 1.94)

0.61 (0.63 to 1.84)
0.08 (1.18 to 1.02)

0.158
0.332
0.882

Unadjusted mean outcomes (standard deviation)

Outcome
Pain (NPRS)
2/52
6/52
52/52
Disability (RMDQ)
2/52
6/52
52/52
Function (PSFS)
2/52
6/52
52/52

p-value

Numerical Pain Rating Scale (NPRS): where 0 = no pain and 10 = pain as bad as it could be. Roland-Morris Disability Questionnaire (RMDQ): where 0 = no
disability and 24 = severe disability. Patient-Specic Functional Scale (PSFS): patient nominated three important activities which were limited by their
injury and rated these on a Likert scale ranging from 0 (unable to perform the activity) to 10 (able to perform the activity at pre-injury level). The scores
were summed and averaged producing a score out of 10.

2.7 Data analysis

3. Results

The sample size of 64 was determined a priori

(Panagopoulos et al., 2013). This sample size was calculated to provide 80% power to detect a 1.5 point
difference (which we considered to be a worthwhile
effect) on the 010 NPRS, allowing for an estimated
standard deviation of 2 and loss to follow-up of 10%.
An unstructured covariance matrix was assumed,
although the results were very similar using a range of
other structures (autoregressive, Toeplitz, HuynhFeldt, compound symmetry).
All data were double entered. Data analysis was
performed by a statistician who was blinded to group
status and following intention-to-treat principles. The
number of analyses was limited to reduce the possibility of type I errors. For primary outcomes, a p-value
of <0.05 was considered statistically significant. For
the secondary outcomes, a p-value of <0.01 was considered significant. For our primary outcome of NPRS
at 6 weeks, we considered a 1.5 point difference
between groups to represent the smallest worthwhile
effect.
The mean effects of intervention on pain intensity,
disability and function were calculated using linear
mixed models which incorporated terms for treatment, time and treatment time interactions. The
coefficients of the treatment time interactions delivered estimates of the effects of visceral manipulation
treatment. Between group differences were presented
as unadjusted mean outcomes for both groups and
adjusted treatment differences (Table 1).

Ninety-eight participants presenting for management

of nonspecific LBP were screened for inclusion into
the study, between September 2010 and September,
2012 (Fig. 1). Eighteen participants chose not to participate and 12 did not meet the study inclusion
criteria (Fig. 1). Of the 64 participants allocated to
the study, 100% provided week 2 follow-up data
(n = 64); 98% provided week 6 follow-up data
(n = 63) and 92% provided week 52 follow-up
data (n = 59). The characteristics of participants allocated to the two treatment groups are shown in
Table 2. Participants were well matched for most variables but control participants had shorter duration of
symptoms (9.5 days compared with 20) and more
reported pain below the knee (41% or participants
compared with 15%).
By 6 weeks, participants in the control group
received a median of five treatments [interquartile
range (IQR) = 2.8] and visceral manipulation group
participants received a median of five treatments (IQR
3.0). By 52 weeks, control group participants had
received a median of six treatments (IQR = 5.8) and
visceral manipulation group participants received a
median of seven treatments (IQR = 9.8). The majority
of participants in both groups believed they were
receiving the real treatment (90% of the control
group and 80% of the visceral manipulation group).
No adverse events were reported by any participant in
this study. Only one patient (from the control group)
sought other treatment during the follow-up period.

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Table 2 Baseline characteristics.

Characteristics

Sham visceral manipulation

Visceral manipulation

Sex, females, number (%)

Pain intensity (NPRS), mean (SD)
Disability (RMDQ), mean (SD)
Function (PSFS), mean (SD)
Presence of one or more visceral symptoms
Duration of episode in days, median (IQR)
Number of previous episodes, median (IQR)
Pain radiating below knee, number (%)

20 (63%)
5.38 (1.8)
10.2 (5.6)
3.75 (1.65)
53%
9.5 (25)
2.5 (7)
13 (41%)

19 (59%)
5.25 (1.9)
8.9 (6.0)
4.50 (1.66)
50%
20 (83)
3 (5)
5 (16%)

Numerical Pain Rating Scale (NPRS): where 0 = no pain and 10 =pain as bad as it could be. Roland-Morris Disability Questionnaire (RMDQ): where 0 = no
disability and 24 = severe disability. Patient-Specic Functional Scale (PSFS): patient nominated three important activities which were limited by their
injury and rated these on a Likert scale ranging from 0 (unable to perform the activity) to 10 (able to perform the activity at pre-injury level). The scores
were summed and averaged producing a score out of 10. IQR, interquartile range; SD, standard deviation.

The treatment time interaction was significant for

pain (p = 0.022). For the primary outcome of pain
(NPRS) at 6 weeks, there was no significant between
group difference [0.12, 95% confidence interval
(CI) = 1.45 to 1.21]. Similarly, there was no significant difference between groups for pain at 2 weeks
(0.55, 95% CI = 0.65 to 1.75). At 52 weeks, those
receiving visceral manipulation improved on average
by 1.57 (95% CI = 0.32 to 2.82) points more than
those in the control group (Table 1 and Fig. 2).
The treatment time interaction was nonsignificant
for both disability (p = 0.473) and function
(p = 0.336). There were no significant between group
effects for pain or disability at any time point. (Table 1
and Figs. 3 and 4).

4. Discussion
4.1 Main ndings
This is the first randomized, placebo controlled blinded
trial investigating the use of visceral manipulation in

patients with LBP. The addition of visceral manipulation to standard care did not improve the primary
outcome of pain at 6 weeks. At the 52-week followup, those receiving visceral manipulation had 1.69
points less pain (CI = 0.32 to 2.82) than those receiving placebo visceral manipulation, which exceeded
our smallest worthwhile effect but caution is required
as this was a secondary outcome and the p-value was
>0.01 (p = 0.015) which we set for secondary outcomes. The addition of visceral manipulation did not
improve disability or function in these patients at any
of the follow-up times.

4.2 Strengths and weaknesses

The strength of this study is the use of a placebo
control and evidence of successful blinding. We also
achieved high follow-up rates throughout the 12
months. In addition, we prospectively registered the
trial and published the trial protocol in a peerreviewed journal (Panagopoulos et al., 2013).

Figure 2 Changes in pain [010 Numerical

Pain Rating Scale (NPRS)] from baseline at 2, 6
and 52 weeks in the visceral manipulation (VM)
group (squares) and placebo VM group (triangles). Data shown as group means and 95%
condence intervals.

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Does visceral manipulation alter low back pain outcomes?

Figure 3 Changes in disability [024 RolandMorris Disability Questionnaire (RMDQ)] from

baseline at 2, 6 and 52 weeks in the visceral
manipulation (VM) group (squares) and
placebo VM group (triangles). Data shown as
group means and 95% condence intervals.

A weakness of this study is that the treating

therapists were not blinded to treatment group as
this was not possible. Great care was taken by
treating therapists to stay on message during treatment of placebo subjects. The treatment credibility
results at 6 weeks provide evidence the therapists
delivered an equally credible intervention to both
groups.
At baseline, despite rigorous randomization and
concealment processes, both groups were not well
matched for all baseline characteristics, with those in
the control group having shorter median duration of
symptoms and more commonly reporting pain below

the knee. A shorter duration of symptoms has been

associated with better outcomes (Dunn and Croft,
2006), while pain below the knee has been associated with poorer outcomes (Grotle et al., 2010).
Therefore, it is possible that these differences
between the groups at baseline contributed to an
underestimation of the treatment effect. It is also
possible that the presence of leg pain in control
group patients caused these participants to have
long-term higher pain levels; however, the authors
feel this is unlikely given both groups had very
similar baseline pain levels.

4.3 Comparison with other studies

Figure 4 Changes in function [010 Patient-Specic Functional Scale

(PSFS)] from baseline at 2, 6 and 52 weeks in the visceral manipulation
(VM) group (squares) and placebo VM group (triangles). Data shown as
group means and 95% condence intervals.

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Despite the growing use of visceral manipulation techniques (Panagopoulos et al., 2013), there have been
very few studies investigating the use of visceral
manipulation techniques in LBP and no other randomized controlled trials have been conducted. One
study, conducted by Tozzi et al. (2012) showed immediate pain reduction following visceral manipulation
treatment indicating there may be short-term benefits
of visceral manipulation in reducing LBP (Tozzi et al.,
2012). However, patients were not blinded and no
control group was included. Our study did not
measure immediate effects but we found no effect at 2
weeks, which was our shortest follow-up time. It is
possible that, like other manual therapies (Vicenzino
et al., 2001), visceral manipulation has short-term
hypoalgesic effects but these differences could also be
explained by the fact that our study investigated visceral manipulation in conjunction with standard care
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Does visceral manipulation alter low back pain outcomes?

and that we used a placebo to blind participants to

treatment.

4.4 Meaning of the study/implications

for clinicians
Our study suggests that visceral manipulation in addition to standard care is not effective in changing shortterm outcomes but may produce clinically worthwhile
improvements in pain at 1 year. Given the favourable
natural prognosis of most acute low back pain (Da C
Menezes Costa et al., 2012), it would suggest that visceral manipulation need not be used in the early
stages of a LBP presentation, but may be considered in
patients who are not recovering appropriately in the
first few weeks.
An interesting and somewhat unexpected finding
from our study was the significant effect on pain at 12
months despite no treatment effect at 2 or 6 weeks.
While this needs to be interpreted cautiously, there are
mechanisms which may explain this finding. It is possible that, with continuing visceral nociceptive input,
control patients experienced greater rates of recurrences of LBP compared with the visceral manipulation group. This could explain the elevated mean pain
scores between 6 and 52 weeks in the control group,
while the visceral manipulation group mean pain
scores continued to reduce over the same time period.
Rates of recurrence within a year in a similar cohort
were reported to be approximately 33% (Stanton
et al., 2008).
Our study included all LBP patients presenting for
therapy that met the inclusion criteria and consented
to participate. It is important to be cognizant that
visceral disorders/pain maybe an important contributor in only a proportion of these patients
(Panagopoulos et al., 2014). We did not distinguish
between acute or chronic patients as there was not
an existing rationale why the duration of pain would
cause patients to respond differently to the additional
treatment. Currently, there is no evidence for the
validity of visceral assessment procedures, so it is difficult to advise if patient selection would improve
outcomes. However, clinicians should be suspicious
of a visceral contribution to LBP in the case of
history of medically diagnosed visceral pain disorders
(such as irritable bowel syndrome or dysmenorrhea).
Further research could include investigating the
effectiveness of visceral manipulation in patients
with LBP and medically diagnosed visceral pain
disorders. Additional research into the reliability
and validity of visceral assessment procedures is
required.
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5. Conclusion
This is the first randomized, placebo controlled trial
investigating the use of visceral manipulation in
patients with LBP. No significant difference was found
between groups in the short to medium term, with
respect to pain, disability and function. Clinically
meaningful between-group differences in pain were
found at 1 year.
Author contributions
All authors have approved the manuscript and agree with its
submission to European Journal of Pain. M.J.H. and P.F.
were instrumental in the study conception and design. J.H.
provided guidance regarding pain science and the manuscript. P.P. created the statistical modelling, assisted with data
analysis and interpretation and assisted with the manuscript
regarding data analysis. All authors discussed the results and
commented on the manuscript.

Acknowledgements
The authors thank Mr Andrew Renkert for his clinical assistance. The authors thank Ms Stefanie de Marinis for her
administrative assistance.

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