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British Journal of Oral and Maxillofacial Surgery xxx (2016) xxx–xxx

Hilotherapy for the management of perioperative pain and


swelling in facial surgery: a systematic review and
meta-analysis
G.E. Glass a,b , N. Waterhouse a , K. Shakib c,∗
a Wellington Hospital, HCA Healthcare, London, UK
b Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK
c Department of Oral & Maxillofacial Surgery, Royal Free London NHS, London UK

Accepted 4 July 2016

Abstract

Hilotherapy is the application of cold compression at a regulated temperature through a face mask. Studies that have evaluated its efficacy
have focused on postoperative oedema, pain, and the patient’s comfort. However, there is no clear consensus in favour of its use, so we
have made a systematic review and meta-analysis to evaluate relevant published reports. We searched PubMed, EMBASE, MEDLINE, the
Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials to identify studies. Sixty-one records were
screened, six of which met the inclusion criteria and four of which were suitable for meta-analysis. All data suitable for meta-analysis were
derived from studies of elective and traumatic facial skeletal surgery. Hilotherapy was associated with significant reductions in facial pain on
postoperative day 2 (p < 0.00001), and facial oedema on days 2 (p = 0.0004) and 3 (p = 0.02). Patients reported more comfort and satisfaction
with hilotherapy than with cold compression (p < 0.00001). The effect of hilotherapy on ecchymosis and formation of haematomas remains
uncertain. Well-designed, randomised, controlled trials of its use after aesthetic facial surgery are required.
© 2016 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Keywords: Hilotherapy; Hilotherm®; cryotherapy; facial surgery; orthognathic surgery; oedema; facial pain; post operative cooling

Introduction been concerns that it may impair microvascular blood flow


and lymphatic drainage, and cause cold burns or nervous
Cryotherapy is a traditional way of minimising pain, swelling, injury. 4,5
and discomfort after trauma or facial surgery, but the qual- Hilotherapy (Hilotherm®, Hilotherm GmbH, Lud-
ity of evidence is poor (Collier J et al. Facial cooling wigshafen, Germany) uses a prefabricated, facially-
following orthognathic surgery-pilot data and recommen- contoured, polyurethane mask to channel a current of cool,
dations for a multi-centre study. Paper presented at the sterile water adjacent to the skin to provide regulated
annual scientific meeting of the British Association of Oral cryotherapy perioperatively.6 As it provides a way of stan-
and Maxillofacial Surgeons, 2012)1–3 and there have even dardising cryotherapy, it can be evaluated in a randomised,
controlled trial. Published studies have given conflicting

results, and to draw conclusions about its efficacy we have
Corresponding author. Tel.: +020 82164271.
E-mail address: k.shakib@nhs.net (K. Shakib).
evaluated the evidence systematically.

http://dx.doi.org/10.1016/j.bjoms.2016.07.003
0266-4356/© 2016 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Glass GE, et al. Hilotherapy for the management of perioperative pain and swelling in facial surgery: a
systematic review and meta-analysis. Br J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.bjoms.2016.07.003
YBJOM-4940; No. of Pages 6
ARTICLE IN PRESS
2 G.E. Glass et al. / British Journal of Oral and Maxillofacial Surgery xxx (2016) xxx–xxx

Methods participants, operation, temperature of the hilotherapy, com-


parative technique, and outcomes. Continuous outcomes
Search were calculated using the mean difference and 95% CI for
each trial. For dichotomous outcomes we calculated risk
We searched PubMed, EMBASE (OvidSP), Medline ratios (RR) and 95% CI for each trial. We used both random-
(OvidSP), the Cochrane Database of Systematic Reviews, effect and fixed effects models in our meta-analysis: in a
and the Cochrane Central Register of Controlled Trials, using fixed-effect analysis the true effect size is assumed to be the
medical subject heading (MeSH) and free-text terms. We also same in all included studies, while in a random-effects model
scrutinised the online trials registers ClinicalTrials.gov and the true effect size varies between studies. The summary
the national research register for completed, discontinued, effect is the estimate of the mean of these effects. In practice,
and ongoing trials about the use of cryotherapy and hilother- the random-effects model gives more weight to smaller stud-
apy in facial surgery. The search was made in accordance ies than the fixed-effects model does. Our rationale was to
with the Cochrane Highly Sensitive Search Strategy guideline use the random-effects model a priori as we assumed there
in the Cochrane handbook for systematic reviews of inter- to be variance between studies, but we calculated the vari-
ventions. 7 The review is reported in line with the Preferred ance within each study and if it was low we used the fixed
Reporting Items for Systematic Reviews and Meta-analyses effects model. For more details please refer to Introduction to
(PRISMA) statement. 8 meta-analysis by Borenstein et al., 12 Variance (statistical het-
erogeneity) was calculated both with the chi square test and
Inclusion criteria the I2 statistic. A chi square test with p <0.10 or an I2 > 50%
were taken to indicate significant heterogeneity. Heteroge-
We included randomised controlled trials that compared neous data were pooled using the random-effects model while
facial cooling by hilotherapy with standard dressings or cold homogeneous data were pooled using the fixed-effect model.
compression after facial reconstructive or aesthetic proce- As all studies of oedema, pain, and patients’ satisfaction
dures in both adults and children. Where there were two or that we included used the same scales, the forest plots were
more clinically homogeneous studies, data were pooled in a calculated using mean difference, not standardised mean dif-
meta-analysis. ference. In accordance with the limited number of trials
included for each outcome, we did not construct a funnel
Exclusion criteria plot to investigate reporting bias. For statistical analysis we
used Review Manager (RevMan) (version 5.3, Copenhagen:
Prospective, comparative, and case-control studies were the Nordic Cochrane Centre, the Cochrane Collaboration,
mentioned in the text, but not analysed further. Published 2014).
abstracts, posters, and theses were excluded.

Outcome measures Results

Primary outcome measures were oedema and pain. Sec- General


ondary outcome measures were tolerance, haematoma, and
ecchymoses. In three of four trials included, facial oedema Sixty-one abstracts and seven full texts were assessed for eli-
was measured using 3-dimensional volumetric morphomet- gibility. Six trials involving 286 patients met the inclusion
ric imaging software. In the case of elective facial surgery a criteria 9,10,13–16 and four were suitable for meta-analysis
preoperative scan was used to establish a reference volume. In (Fig. 1). 13–16 Men accounted for around half of all study
the case of emergency facial surgery for trauma a late postop- participants and for 62 of 74 (84%) of participants in the
erative scan was used to establish a reference volume. In the two studies of facial trauma. All trials used Hilotherm® at
remaining trial, facial oedema was evaluated from a series of 14-15 ◦ C. In all but one the hilotherapy mask covered the mid-
measurements made from the fixed point of the tragus.9 The dle and lower thirds of the face, and in the remaining case it
final trial qualitatively evaluated facial oedema and ecchy- covered the upper and middle thirds. 13 In each case hilother-
mosis at routine postoperative review and was excluded from apy was started immediately postoperatively, but the regimen
further analyses. 10 A visual analogue scale (VAS) of 0-10 varied thereafter from a single application of 45 minutes
was used to evaluate facial pain in four of the studies while after third molar extractions 15 to a continuous period of
one used a scale of 1-4 where 1 indicated no pain and 4 48 hours, or 48 -72 hours after orthognathic surgery. 9,14 The
indicated severe pain. 10 Hilotherm® masks are shown in Fig. 2.
The control arm comprised cool compresses in four stud-
Collection and analysis of data ies and dressings alone in only one.10 In the remaining study,
both controls were incorporated into the study design.9 Four
Studies were assessed for risk of bias. 11 For all stud- of the six trials evaluated facial oedema objectively, using
ies included in the meta-analysis we recorded details of the same 3-dimensional volumetric morphometric imaging

Please cite this article in press as: Glass GE, et al. Hilotherapy for the management of perioperative pain and swelling in facial surgery: a
systematic review and meta-analysis. Br J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.bjoms.2016.07.003
YBJOM-4940; No. of Pages 6
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G.E. Glass et al. / British Journal of Oral and Maxillofacial Surgery xxx (2016) xxx–xxx 3

Fig. 1. Search of databases and selection of publications for study.


Fig. 2. The Hilotherm® face masks. A = Upper and mid face; B = middle
and lower face.
software.13–16 Five of the six studies also evaluated facial
pain using semiquantitative scales. 10,13–16 In four, the doc- was analysed statistically and compared with the baseline
umentation of results was sufficiently detailed to permit a measurements.
meta-analysis.13–16 The studies included are summarised in The studies suitable for meta-analysis reported heteroge-
the table (supplemental data, online only), and a risk of bias neous data on day 2 (chi square p < 0.00001, I2 = 89%) and
assessment in Fig. 3. day 3 (chi square p < 0.0001, I2 = 96%) so a random effects
model was used. By contrast, data reported on day 28 were
homogeneous (chi square p = 0.7, I2 = 0%) so a fixed effect
Facial oedema model was used. As shown in Fig. 4, hilotherapy (applied
immediately postoperatively) was associated with a signifi-
Five trials quantitatively evaluated the influence of hilother- cant reduction in facial oedema on day 2 (Fig. 4A; p = 0.0004)
apy on facial oedema. The risk of selection bias was not clear and day 3 (Fig. 4B; p = 0.02); an effect which had normalised
because details about the methods of randomisation were by day 28 (Fig. 4 C; p = 0.39).
inadequate, but as the risk of other forms of bias was low
in four of the five, these four were included in the meta- Facial pain
analysis. By contrast, the description of the study’s design
was not sufficiently detailed in the paper by Moro et al to Of the five trials that evaluated the effect of hilotherapy on
permit numerical or demographic comparison of the three postoperative facial pain, four used the VAS of 0-10 while one
arms,9 and while the design stated that measurements were 10 used a scale of 1-4, where 1 indicated no pain and 4 severe

made at three intervals postoperatively, only one (24 hours) pain. However, this trial did not report the data in sufficient

Risk of bias assessment

First author and Random Allocation Blinding of Incomplete Blinding of Incomplete Free from Free from
reference Sequence Concealment? outcome outcome outcome outcome selective other bias?
Generation? assessment data 1 assessment data 2 reporting?
1? addressed? 2? addressed?
Oedema Oedema Pain Pain
Reconstructive
Rana (14) Unclear Unclear Yes Yes No Yes Unclear Yes
Rana (15) Unclear Unclear Yes Yes No Yes Unclear Yes
Rana (16) Unclear Unclear Yes Yes No Yes Unclear Yes
Modabber (13) Unclear Unclear Yes Yes No Yes Unclear Yes
Moro (9) Unclear Unclear No Unclear N/A N/A No Unclear

Aesthetic
Jones (10) Yes Unclear No No No No Unclear Yes

Fig. 3. Risk of bias assessment.

Please cite this article in press as: Glass GE, et al. Hilotherapy for the management of perioperative pain and swelling in facial surgery: a
systematic review and meta-analysis. Br J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.bjoms.2016.07.003
YBJOM-4940; No. of Pages 6
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Fig. 4. Facial oedema: a forest plot showing a meta-analysis of hilotherapy compared with cold compression on postoperative day 2 (A), day 3 (B), and day
28 (C).

Fig. 5. Facial pain: a forest plot showing a meta-analysis of hilotherapy compared with cold compression on postoperative day 2.

detail to permit inclusion in the meta-analysis. All four stud- Discussion


ies included reported data on pain from postoperative day 2,
and because they were statistically heterogeneous (chi square We have systematically evaluated the evidence for the use of
p = 0.005, I2 = 77%) a random effects model was used. Fig. 5 perioperative hilotherapy after facial surgery. Meta-analysis
shows that there was a significant reduction in pain associated showed that when it was used in the immediate postopera-
with hilotherapy on postoperative day 2 (p < 0.00001). tive period it significantly reduced swelling within the first
72 hours. Patients reported that pain was significantly less
on postoperative day 2 and they were more satisfied with
dressings at the time of discharge. In most cases hilotherapy
Subjective satisfaction was compared with cold compression, although two studies
(excluded from the meta-analysis) compared it with standard
Four trials evaluated the patients’ satisfaction with hilother- facial dressings alone.
apy or cool compression, using an ordinal scale from 1 to If patients who had both elective facial surgery and oper-
4 where 1 was very “satisfied” and 4 was “not satisfied”. In ations for trauma experience significantly less postoperative
each case patients were asked to report their experience at the pain and swelling after hilotherapy, then the recovery period
time of discharge. The remaining trial, which simply reported might be shortened, with implications for the resumption of
that eight of 15 patients found hilotherapy soothing, was preoperative activities. This may also have implications for
excluded from the meta-analysis.10 Studies included were the development and subsequent resolution of ecchymoses
statistically homogeneous (chi square p = 0.39, I2 = 0%), so which, although not assessed objectively in any of the stud-
a fixed effect model was used. As shown in Fig. 6, patients ies, also contribute to the duration of recovery. As we seek to
were significantly more satisfied with hilotherapy than with make our patients as comfortable as possible, it is useful to
cold compression (p < 0.00001). know that the hilotherapy facemask was well-tolerated and

Please cite this article in press as: Glass GE, et al. Hilotherapy for the management of perioperative pain and swelling in facial surgery: a
systematic review and meta-analysis. Br J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.bjoms.2016.07.003
YBJOM-4940; No. of Pages 6
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G.E. Glass et al. / British Journal of Oral and Maxillofacial Surgery xxx (2016) xxx–xxx 5

Fig. 6. Subjective comfort and satisfaction: a forest plot showing a meta-analysis of hilotherapy compared with cold compression on semiquantitative scale at
discharge.

significantly more comfortable than cold compression dress- a superficial muscular aponeurotic system (SMAS)-based
ings during the early postoperative period, and it supports our rhytidectomy to Hilotherm® or standard dressings.10 They
own observations. reported no difference in facial oedema noted by a doctor on
One important caveat is that hilotherapy with Hilotherm® day 1 and, in a subsequent arm of the study that involved
is more expensive both in terms of hardware and nursing 15 patients, reported greater subjective swelling at days 6-8
than simple dressings. The cooling unit costs about £4500 on the hemifaces randomised to perioperative Hilotherm®.
(November 2015), and the cost:benefit ratio is for each prac- Martin et al described a study of 54 patients randomised to
titioner to consider. have Hilotherm®, Hilotherm® dressings (not circulating), or
The finding that hilotherapy was more effective than cold no dressings, after sagittal split osteotomy.23 They found no
compression may simply result from differences in surface differences in reported pain from days 1-7 in either group,
contact, with the contoured hilotherapy mask applied across but the study lacked sufficient power to answer the question.
a wider area. Alternatively, standard cryotherapy is likely to This systematic review was limited because of the paucity
vary in temperature (becoming warmer over time), which of high-quality, randomised, controlled trials on the use
hilotherapy does not. Finally, the gauze dressing is likely of hilotherapy in facial surgery. Those that we included
to exert a tangible, but poorly-defined, influence on thermal used the same methods in their approach, which supports
conduction. Jones at al attempted to explain this, although the need for standardisation. The meta-analysis is based on
with only 15 patients and the lack of a standard, measurable 146 patients, with the control intervention being cold com-
outcome they could draw no definite conclusions.10 pression. While this control was probably adopted to satisfy
Facial cooling exerts physiological influences that depend clinical equipoise, the reality is that often no topical treatment
on the temperature of the skin, so a system that applies is given in the perioperative period, so a further control arm
a regulated temperature for a given time yields a more is advisable in future studies, as adopted by Moro et al.9 As
consistent physiological response than one with no such our systematic review has yielded analysable data from only
regulation. For example, physiological cooling exerts an 146 patients, it is clear that many surgeons use this technique
autonomic-mediated vasoconstrictive effect which, in theory, pragmatically rather than scientifically.
minimises oedema and ecchymosis. 17,18 At low temperatures As the studies included all evaluated hilotherapy after elec-
the activity of neutrophils, which synthesise proinflammatory tive and traumatic oral and maxillofacial surgery, the extent
cytokines to mediate pain and swelling, is impaired. When to which our findings are relevant to aesthetic surgery may be
the local temperature falls below about 14 ◦ C the propaga- debated. However, extrapolation of the data about postopera-
tion of action potentials along autonomic and sensory nerves tive swelling, pain, and patients’ satisfaction is reasonable.
is impaired (cold-induced neuropraxia), 19 resulting in para- None of the studies were designed to address specific con-
doxical vasodilatation and paraesthesia. Facial cooling also cerns related to aesthetic surgery such as ecchymosis and
results in bradycardia, and increases blood pressure and cere- haematoma that arise as a consequence of the creation of sur-
bral blood flow.20 Transient apnoea increases this bradycardic gical planes dissimilar to those used in these studies. Given
response, which may have implications for postoperative the paucity of data, it seems reasonable to call for well-
sedation with hilotherapy.21 designed, randomised, controlled trials of hilotherapy in the
Patients’ satisfaction with hilotherapy may have several postoperative management of facial aesthetic surgery.
explanations. For example, once applied, the hilotherapy The second limitation of this review is that all the studies
mask does not have to be manipulated, unlike standard cold suitable for meta-analysis were done by the same investiga-
compression gel packs, which required replacement. Naka- tors. The addition of further studies by different groups using
mura et al found that during mild exposure to heat, thermal robust techniques and standard data would be welcome.
comfort varied according to which area of the body was Further research on the use of hilotherapy would be
cooled topically, with facial cooling inducing the greatest improved if the features that define successful treatment
comfort.22 These data suggest that facial cooling is inherently were clarified, and standard methods were used to obtain the
soothing. data. Volumetric data should be obtained using 3-dimensional
Our findings are at odds with those of Jones et al, imaging, while subjective outcomes should use validated
who randomised 50 consecutive patients who were having scoring systems such as the VAS for pain. Studies would

Please cite this article in press as: Glass GE, et al. Hilotherapy for the management of perioperative pain and swelling in facial surgery: a
systematic review and meta-analysis. Br J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.bjoms.2016.07.003
YBJOM-4940; No. of Pages 6
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6 G.E. Glass et al. / British Journal of Oral and Maxillofacial Surgery xxx (2016) xxx–xxx

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Please cite this article in press as: Glass GE, et al. Hilotherapy for the management of perioperative pain and swelling in facial surgery: a
systematic review and meta-analysis. Br J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.bjoms.2016.07.003

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