A systematic literature review of spinal …RESEARCH ARTICLE Open Access A systematic literature...
Transcript of A systematic literature review of spinal …RESEARCH ARTICLE Open Access A systematic literature...
RESEARCH ARTICLE Open Access
A systematic literature review of spinalbrace/orthosis treatment for adults withscoliosis between 1967 and 2018: clinicaloutcomes and harms dataJeb McAviney1, Johanna Mee2, Azharuddin Fazalbhoy2,3 , Juan Du Plessis1 and Benjamin T. Brown1,4*
Abstract
Background: There is a paucity of literature regarding the conservative management of adult scoliosis. The authorsreview and summarize the literature from 1967 to 2018 on the clinical outcomes of spinal brace/orthosis use in thissubgroup of the population.
Methods: CINAHL, Embase, CENTRAL, PubMed and PEDro were searched from database inception to the 30th ofOctober, 2018. A combination of medical subject heading terms and keywords pertaining to three core concepts(adult, scoliosis, and braces/orthoses) were used in the search. Studies were included if A) clinical outcomes werecollected from B) participants ≥18 years C) receiving spinal brace/orthosis treatment for D) primary degenerative (denovo) scoliosis or progressive idiopathic scoliosis. A step-wise screening process was employed which involved atitle and abstract screen for relevancy followed by a full text eligibility appraisal by two authors. Data wereextracted, and a risk of bias assessment was performed on the included cohort studies using the Newcastle-OttawaScale. Given the overall level and quality of the available evidence, conclusions were drawn based on a qualitativesummary of the evidence.
Results: Ten studies (four case reports and six cohort studies) were included which detailed the clinical outcomesof soft (2 studies) or rigid bracing (8 studies), used as a standalone therapy or in combination with physiotherapy/rehabilitation, in 339 adults with various types of scoliosis. Most studies included female participants only.Commonly reported outcomes were pain (7 studies), function (3 studies) and Cobb angles (3 studies), with follow-up times ranging from 2 days to 17 years. Brace wear prescriptions ranged from 2 to 23 h per day, and there wasmixed brace-compliance reported. Most studies reported modest or significant reduction in pain and improvementin function at follow-up. There were mixed findings with regards to Cobb angle changes in response to bracing.Participants from one study noted discomfort associated with bracing. Each of the six cohort studies demonstrateda high risk of bias.
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© The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
* Correspondence: [email protected] Scoliosis Clinic, Kirk Place, Level 5, Suite 5.08, 15 Kensington St,Kogarah, NSW 2217, Australia4Department of Chiropractic, Macquarie University, North Ryde, NSW 2109,AustraliaFull list of author information is available at the end of the article
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 https://doi.org/10.1186/s12891-020-3095-x
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Conclusion: There is evidence to suggest that spinal brace/orthosis treatment may have a positive short – mediumterm influence on pain and function in adults with either progressive primary (de novo) degenerative scoliosis orprogressive idiopathic scoliosis. At this point in time the evidence is of low quality and has been focused primarilyon female patients with thoracolumbar and lumbar curves. More granular statements regarding the efficacy ofdifferent brace types or manufacturers, or the effect of this therapy on different curve types cannot be determinedbased on the current literature. Properly constructed prospective trials are required to better understand theefficacy of bracing in adult scoliosis.
Keywords: Braces, Adult, Scoliosis, Therapeutics, Pain
BackgroundScoliosis represents a deviation of the spine in the coronalplane with associated vertebral rotation [1]. Whilst thereare many different types of scoliosis that may manifest atvarious points across the lifespan, several variants havebeen identified that are specific to adult populations - seeAebi [2] for a full review and classification. The mostcommon types of adult scoliosis include primary de novodegenerative scoliosis and progressive idiopathic scoliosis[2]. Primary degenerative scoliosis represents a new (denovo) curve that develops in patients with no prior historyof scoliosis, and typically affects the lumbar or thoroaco-lumbar spine. The prevalence of the primary degenerativescoliosis has been reported to be as high as 68% in individ-uals aged 60–90 years [3]. Progressive idiopathic scoliosisrepresents curve progression and spinal degeneration inadults with pre-existing idiopathic curves [2].It has been proposed that changes in the structure, func-
tion, and physiological alignment of the spine lead toasymmetrical loading which provokes further degenerativechange, accelerated curve progression and postural col-lapse [4]. Depending upon the timing of presentation itcan be challenging to differentiate between the varioustypes of adult scoliosis, however most patients will presentwith back pain accompanied by some form of progressivepostural deformity [5]. In the more severe cases, patientsmay experience lumbar radiculopathy, myelopathy and/or intermittent neurogenic claudication due to theadvanced nature of degenerative changes [6, 7] such asasymmetrical disc degeneration, spondylosis/facet in-competence and hypertrophy and calcification of theligamentum flavum. Foraminal/lateral-recess/central sten-osis and/or neural stretching or tethering can also beobserved in such cases [7].Managing the progressive nature of this condition whilst
preserving quality of life can present a unique challenge.Adult patients with scoliosis are generally encouraged toexplore conservative treatment options prior to undergoingsurgical intervention [8]. However, there is limited evi-dence regarding the effectiveness of conservative treatment[9]. Bridwell et al [10] investigated the impact on quality oflife (QOL) of surgical and non-surgical treatments on 160
symptomatic adults with lumbar scoliosis using a pro-spective observational cohort study design. The non-surgical (75 participants) treatments included observation(21%), medication (26%), medication combined with phys-ical therapy and/or injection techniques (40%), and othertreatment without medications (13%). The authors foundthat surgical treatment of adults with scoliosis resulted insignificant improvement in QOL after 2 years, whereas thenon-surgical treatments had no significant effect. Inter-pretation of the findings from the non-surgical group werehowever hampered by substantial loss to follow-up (45%).There is a growing body of evidence regarding the influ-
ence of physiotherapeutic scoliosis specific exercise for thetreatment of adolescent idiopathic scoliosis patients.However, research into the efficacy of this type of treat-ment for adult scoliosis patients is in its infancy. This isevidenced by a recent systematic literature review per-formed by Alanazi et al [11] that looked into the effects ofstabilization exercises on back pain, disability and qualityof life in adults with scoliosis. A comprehensive search ofthe available literature revealed only one randomisedparallel-group, superiority-controlled trial [12] that ful-filled the author’s eligibility criteria for the review. Theauthors of this single randomised controlled trial soughtto investigate the effects of motor and cognitive rehabilita-tion on disability in 130 adults with idiopathic scoliosis(low-moderate curves [< 35° Cobb-Lippman]). The inter-vention consisted of 20 weeks of active self-correction ex-ercises that were reinforced with strengthening exercisesand challenged with task-oriented activities and other pos-tural perturbations. In addition, participants also receivedcognitive behavioural therapy and ergonomic advice. Theauthors of the study found significant improvements inpain, disability and QOL scores that were superior to gen-eral physiotherapy treatment. As is the case for all trialsinvolving complex exercise interventions, blinding was notpossible. Consequently, Alanazi et al assessed this trial ashaving a high risk of bias and called for further experi-mental research in this area.There is good evidence to support the use of bracing
for adolescent idiopathic scoliosis (AIS) [13]. In contrast,there is a paucity of literature regarding this type of
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 2 of 12
treatment for adult patients. In adults, the thoracolum-bosacral (TLSO) or lumbosacral orthoses (LSO) arecomparable in appearance and utilize similar materialsto those used in pediatric populations, however thepurpose and proposed mechanism of action is different.Instead of trying to modulate spinal growth, as is thecase in adolescent patients, the primary aim of adultbracing is to apply external forces to the spine/trunk totemporarily improve physiological spinal alignment.Adult spines are stiffer than adolescent spines and there-fore less responsive to external corrective forces, so thistype of therapy aims at moving a patient’s spine/trunkinto the best possible physiological alignment with theintention of relieving symptoms that accompany pos-tural deviation/collapse e.g. pain.A recent report from the World Health Organisation
suggests that by 2050, the proportion of the world’spopulation aged > 60 years will nearly double [14], whichwill likely increase the proportion of adults seeking carefor adult scoliosis. It is therefore prudent to understandthe efficacy of both non-surgical and surgical treatments.The aim of this study was to systematically review andsummarise the existing literature from 1967 to 2018 re-garding the efficacy of spinal braces/orthoses for improv-ing clinical outcomes in adults with scoliosis.
MethodsA search was performed in CINAHL complete (EBSCO-host), Cochrane Central register of Controlled Trials,PubMed, Embase (OVID), and Physiotherapy EvidenceDatabase (PEDro) from inception to the 30th of Octo-ber, 2018 in each database. The authors sought to re-trieve all study types investigating the clinical outcomesof spinal brace/orthosis treatment for adults with scoli-osis. A combination of medical subject heading termsand keywords pertaining to three core concepts (adult,scoliosis, and braces/orthoses) were used in the search.A scoping review was performed to obtain a list of brace/orthosis types/manufacturers that could be included inthe search string for the purposes of increasing the sensi-tivity of the search. An example of the search string usedfor the PubMed database is detailed in theAppendix. Stud-ies were eligible for inclusion in the review if they A) col-lected clinical outcomes from B) participants ≥18 years ofage C) who were receiving soft/rigid/super-rigid spinalbrace/orthosis treatment for D) degenerative de novoscoliosis or progressive idiopathic scoliosis in adult lifeand E) were peer-reviewed and published in full-text inEnglish. A scoping review was performed to assess thestate of the literature on the spinal brace/orthosis treat-ment for adults with scoliosis. Due to the general paucityof information on the topic revealed by the scoping re-view, the authors decided to omit inclusion criteria relat-ing to specific clinical outcomes and study types in order
to maximise the search results. Studies that assessed post-operative bracing/casting, or studies that braced partici-pants with types of scoliosis other than degenerative denovo scoliosis or progressive idiopathic scoliosis wereexcluded.Search results were imported into the Endnote bibliog-
raphy management software and then duplicates wereremoved. A title and abstract screen was conducted sep-arately by two authors to remove all clearly irrelevantstudies. Full text copies of the remaining articles werethen obtained, and the eligibility criteria were appliedseparately by two authors. Any disagreements were re-solved by consensus. Forward (using the citations featurein the Scopus database) and reverse citation (bibliog-raphy screen) tracking based on the list of eligible arti-cles was employed to identify any studies that weren’tpicked up by the primary search strategy. A manualsearch was also performed on the Society on ScoliosisOrthopaedic and Rehabilitation Treatment (SOSORT)website [15] for proceedings from each of the annualconferences from 2004 to 2018.Data from eligible articles were extracted independ-
ently by two authors using a data extraction templatecreated by the research team that was piloted on severalstudies prior to use. The review authors sought to cap-ture data on: study design; participant characteristics,working diagnosis; co-morbid illness; brace characteris-tics; proposed mechanism of action; average hours ofbrace-wear; brace-compliance; additional treatment re-ceived; primary and secondary outcomes; information onfollow-ups (frequency and timing); study findings; andinformation on harms/adverse events. A risk of bias as-sessment of all cohort studies was performed independ-ently by two authors using the Newcastle-Ottawa Scale(NOS) [16], and a quality rating (unclear, high, moder-ate, or low) provided for each study based on recom-mendations from the Agency for Healthcare Quality andResearch [17]. Case studies are known to be biased andtherefore a high risk of bias was automatically assignedto these study types.After performing a scoping review, it became clear that
there would likely be no systematic reviews or random-ized controlled trials retrieved on the efficacy of spinalbrace/orthosis treatment for adults with scoliosis. It wasanticipated that this would prohibit the use of meta-analytical techniques for determining effects sizes, or theuse of robust frameworks e.g. GRADE, for summarizingthe research findings. The researchers instead opted fora simple qualitative summary of the research findings re-garding each outcome or adverse event reported basedon the balance of evidence for each outcome. Given thesmall quantity of literature on this topic this methodshould be considered suitably transparent. No additionalanalyses were planned. This report was prepared using
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 3 of 12
the Preferred Reporting Items for Systematic Reviewsand Meta-Analyses (PRISMA) document [18].
ResultsThere were 1645 records identified by the primarysearch strategy. Of these, 325 were flagged as duplicatesand were subsequently removed. The remaining 1320publications were then screened by title and abstract.Sixty-one publications were deemed suitable for full-textappraisal. The full-text copies of these publications wereobtained, and the eligibility criteria were applied inde-pendently by two authors. There were nine eligible stud-ies. Forward and reverse citation-tracking based on thenine eligible publications returned a further 1205 re-cords. These records were screened by title and abstractwhich revealed one additional study [19]. An analysis ofthe proceedings from the SOSORT scientific meetingshighlighted seven abstracts/oral presentations discussingthe effects of bracing in adult populations. Four of theseabstracts could be linked to studies that had been
written up and already included in the review [20, 21].The remaining three abstracts focused on the effects ofthe SpineCor brace in adults [22–24]. There was how-ever insufficient detail provided in these abstracts toallow for inclusion in the analysis. For a description ofthe search and selection process please see Fig. 1.Ten studies (four case reports [6, 25–27] and six cohort
studies [two retrospective [19, 28] and four prospective[20, 21, 29, 30] were included which detailed the clinicaloutcome of soft (two) [21, 26] or rigid eight) [6, 19, 20, 25,27–30] bracing, used as a standalone therapy [6, 21, 26,28–30] or in combination with casting and /or physiother-apy/rehabilitation [19, 20, 25, 27], in 339 participants intotal. There were six different brands of spinal brace/orth-osis represented in this review (Physiologic [6, 29, 30],Lyon [19, 20], SBrace L [27], Gensingen [25], Vesinet [28]and the Peak Scoliosis Brace [21] (Table 1).The diagnoses given to participants in the overall sam-
ple included primary de novo degenerative scoliosis (35[10%]) or progressive idiopathic scoliosis (59 [17%]) or a
Fig. 1 Flowchart of the search and selection process
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 4 of 12
Table
1Summaryof
theEligibleStud
ies
Autho
r(Year)
Metho
dsParticipants
Measuremen
tFind
ings
Weiss
etal(2006)
[6]
Design:Caserepo
rtBraceType:Lordo
sing
spinalorthosis
Tradena
me:Ph
ysiologic
Material:Po
lyethylene
Proposed
MOA:
Sagittalre-alignm
ent
bracethat
hasalordosingactio
nin
thelumbarspine
Additiona
ltreatment:NA
Region
:Germany
Samplesize:1
Age:47
Sex:1Female
Diagn
osis:
Deg
enerative
Scoliosis
Parameters:55°
Lumbarscoliosis
Co-m
orbidIllness:G
rade
IIspinalclaudicatio
nPrescribed
BraceWear:NA
Primaryoutcom
e:VPRS
Second
aryoutcom
e:Walking
distance
Num
berof
F/Upoints:3
Leng
thof
F/U:
T1=2days
T2=10
days
T3=8weeks
Mainfinding
:Red
uctio
nof
1po
int
ontheVPRS
after10
days
that
remaine
dstableat
8weeks
Additiona
lfinding
s:Increase
inwalking
distance
from
800to
8000
atT1,the
n8000
to12,000
atT2.Improvem
entsmaintaine
dat
T3.
Statisticalsig
nifican
ce:N
ABracecompliance:NA
Harmsassociated
with
bracing:NA
Weiss
etal(2006)
[29]
Design:Prospe
ctivecoho
rtstud
yBracetype:Lordo
sing
spinalorthosis
Tradena
me:Ph
ysiologic
Material:Po
lyethylene
Proposed
MOA:
Sagittalre-alignm
ent
bracethat
hasalordosingactio
nin
thelumbarspine
Additiona
ltreatment:NA
Region
:Germany
Samplesize:29
Age:41
years(SD=21)
Sex:29
Females
Diagn
osis:
Scoliosis
Scoliosis
Parameters:37°(SD=22)
Co-m
orbidIllness:N
APrescribed
BraceWear:Minim
umprescriptio
nof
8hpe
rdayfor
7.5mon
ths(SD=5.6)
Primaryoutcom
e:Ro
land
Morris
verbalratin
gscale(0–5
pointscale)
Second
aryoutcom
e:NA
Num
berof
F/U:2
Leng
thof
F/U:
T1=≤1week
T2=>6mon
ths(Avg
=7.5mon
ths)
Mainfinding
:Asign
ificant
redu
ction
inRo
land
Morris
VRSbe
tweenT0
andT1.Smallerbu
tno
n-sign
ificant
redu
ctionin
scores
betw
eenT0
andT2
Additiona
lfinding
s:NA
Statisticalsig
nifican
ce:W
ilcoxon
Test(p<0.001)
Bracecompliance:Po
or.C
ompliance
lostin
themajority
ofpatientsat
the
timeof
thefollow-uppe
riod.
Only
7patientsrepo
rted
wearin
gthe
bracefor>4hat
theT2
Harmsassociated
with
bracing:NA
Weiss
etal(2009)
[30]
Design:Prospe
ctivecoho
rtstud
yBracetype:Lordo
sing
spinalorthosis
Tradena
me:Ph
ysiologic
Material:Po
lyethylene
Proposed
MOA:
Sagittalre-alignm
ent
bracethat
hasalordosingactio
nin
thelumbarspine
Additiona
ltreatment:NA
Region
:Germany
Samplesize:56
Age:NA
Sex:Males
andfemales
Diagn
osis:
Idiopathic=48,
cong
enital=
2,de
novo
dege
nerative=3,othe
r=3
with
chroniclower
back
pain
Scoliosis
Parameters:41°
(Range
=10–91)
Co-m
orbidIllness:N
APrescribed
BraceWear:20
hpe
rdayfor6mon
thsthen
onacase-by-case
basisafter
that
point
Primaryoutcom
e:Ro
land
Morris
verbalratin
gscale(0–5
pointscale)
Second
aryoutcom
e:prog
ressionto
surgeryforchroniclower
back
pain
Num
berof
F/U:2
Leng
thof
F/U:
T1=≤1week
T2=averageof
18mon
ths
Mainfinding
:Red
uctio
nof
Roland
Morris
scores
of3.3to
2.7at
T1,
then
2.7to
2.0at
T2Ad
ditiona
lfinding
s:21
patients
wereableto
completelyremove
thebraceafter6mon
thsdu
eto
the
alleviationof
pain
Statisticalsig
nifican
ce:W
ilcoxon
Test
(p<0.05)
Bracecompliance:NA
Harmsassociated
with
bracing:NA
DeMauroyet
al(2011)
[19]
Design:Retrospe
ctivecoho
rtstud
yBracetype:Rigid
polyethylene
bi-valve
overlapp
edlumbarbrace
Tradena
me:Lyon
brace
Material:Highde
nsity
polyethylene
Proposed
MOA:
Rebalancingof
the
spinein
thefro
ntalandsagittalplane
Additiona
ltreatment:plastercast
(3weeks),ph
ysiotherapy(3weeks)
Region
:France
Samplesize:33
Age:59.9(SD=10.8)[Range
33–77]
Sex:30
females,3
males
Diagn
osis:
Adu
ltscoliosis(lumbar
orthoracolum
bar)
Scoliosis
Parameters:37°SD
=18
(Range
10–75)
Co-m
orbidIllness:N
APrescribed
BraceWear:
Recommen
ded>4hpe
rday
Primaryoutcom
e:Coron
alCob
bangle
Second
aryoutcom
e:coronaland
sagittalbalance,rib
hump
(millim
etres)
Num
berof
F/U:3
Leng
thof
F/U:
T1=6mon
ths
T2=2years
T3=≥5years
Mainfinding
:Cob
bangleincreased
by>5°
in5patients,remaine
dstablein
15patientsandde
creased
in12
patients
Additiona
lfinding
s:Second
ary
outcom
esremaine
dstablein
17patients,im
proved
in12
patientsandworsene
din
2patients
Somepatientswereableto
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 5 of 12
Table
1Summaryof
theEligibleStud
ies(Con
tinued)
Autho
r(Year)
Metho
dsParticipants
Measuremen
tFind
ings
ceasewearin
gthebracedu
eto
acompleteabolishm
entof
theirsymptom
s.Statisticalsig
nifican
ce:Sum
mary
statisticson
lyBracecompliance:60%
ofpatients
werestillwearin
gthebracefor
anaverageof
5hpe
rdayat
T3.
Bracewearrang
edfro
m2to
23h
perday.
Harmsassociated
with
bracing:NA
Gallo
(2014)
[27]
Design:Caserepo
rts
Bracetype:Rigid
TLSO
Tradena
me:SBrace
LMaterial:NA
Proposed
MOA:
Restoringcoronal
orsagittalalignm
entaccording
tothepresen
tingfeatures,tailored
brace
Additiona
ltreatment:Ph
ysiotherapy
Region
:NA
Samplesize:2
Age:Case1=65,C
ase2=NA
Sex:2Females
Diagn
osis:
Deg
enerativescoliosis
Scoliosis
Parameters:NA
Co-m
orbidIllness:N
APrescribed
BraceWear:Determined
bythepatient
Primaryoutcom
e:VA
SandNPRS
Second
aryoutcom
e:QOLand
activity
restrictio
nNum
berof
F/U:N
ALeng
thof
F/U:N
A
Mainfinding
:Case1:Redu
ctionof
8/10
to3/10
pain,3/10functio
nup
to8/10
functio
nCase2:Redu
ctionof
6po
ints
intheVA
Sscale
Additiona
lfinding
s:Ca
se2:Increasedmob
ility
noted
Statisticalsig
nifican
ce:N
ABracecompliance:NA
Harmsassociated
with
bracing:NA
Weiss
etal(2016)
[26]
Design:Caserepo
rtBracetype:Rigid
TLSO
TradeNam
e:Gen
sing
enMaterial:NA
Proposed
MOA:
Restoringcoronal
orsagittalalignm
entaccording
tothepresen
tingfeatures,tailored
brace
Additiona
ltreatment:Scoliosis
specificexercise
(Schroth
20–60min
perday)[Tailored],
offthe
shelfTLSO
onoccasion
Region
:Germany
Samplesize:1
Age:37
Sex:Female
Diagn
osis:
Late
Onset
idiopathic
scoliosis
Scoliosis
Parameters:56°thoracic
curveanda50°lumbarcurve
Co-m
orbidIllness:N
APrescribed
BraceWear:3–4h
perdayforthreedays
perweek
Primaryoutcom
e:VA
SSecond
aryoutcom
e:Self-pe
rceived
QOLandCob
bangle
Num
berof
F/U:2
Leng
thof
F/U:
T1=12
mon
ths
T2=16
mon
ths
Mainfinding
:Low
erback
pain
relieved.
Onlyfeltdu
ringhe
avy
liftin
gAd
ditiona
lfinding
s:LumbarCob
bangleredu
cedfro
m50°to
32°
Statisticalsig
nifican
ce:N
ABracecompliance:NA
Harmsassociated
with
bracing:NA
DeMauroyet
al(2016)
[20]
Design:Prospectivecoho
rtstudy
Bracetype:Rigid
TLSO
(rigid
lordosingbivalvepo
lyethylene
overlapp
ingbrace
Tradena
me:Lyon
Brace
Material:Po
lyethylene
Proposed
MOA:
Diskprotectio
nandathree-dimen
sion
alre-
equilibratio
nof
thespine
Additiona
ltreatment:Specific
physiotherapy
Region
:France
Samplesize:158
Age:56.08(SD=17.35)
Sex:144females,14males
Diagn
osis:
Adu
ltscoliosis(lumbar
orthoracolum
bar)
Scoliosis
Parameters:39.6(SD=16.76)
Co-m
orbidIllness:N
APrescribed
BraceWear:3weeks
ofplastercast,followed
by4hof
bracingeach
dayfor6mon
ths
Primaryoutcom
e:Coron
alCob
bangle,coronaland
sagittalbalance,
ribhu
mp(m
illim
etres)
Second
aryoutcom
e:NA
Num
berof
F/U:1
Leng
thof
F/U:
T1=8.41
years(SD=3.26)[Range
5–17
years]
Mainfinding
:Nosign
ificant
change
tocoronalC
obbangle.56%
remaine
dstable,24%
improved
by>5°,20%
worsene
dby
>5°
Additiona
lfinding
s:Nosign
ificant
change
torib
hump.
Sagittalbalance
worsene
don
average
Statisticalsig
nifican
ce:T-test(p=0.008)
Bracecompliance:23%
wereno
n-compliant
with
theprescribed
brace
wearho
urs
Harmsassociated
with
bracing:No
adverseeven
tsassociated
with
bracing.
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 6 of 12
Table
1Summaryof
theEligibleStud
ies(Con
tinued)
Autho
r(Year)
Metho
dsParticipants
Measuremen
tFind
ings
Polastriet
al(2017)
[27]
Design:Caserepo
rtBraceType:M
odified
offthe
shelfbrace
TradeNam
e:NA
Material:Elastic
Proposed
MOA:
Createcoronal
shiftingforcetowards
concavity
ofthecurve
Additiona
lTreatment:NA
Region
:Italy
Samplesize:1
Age:40
Sex:Female
Diagn
osis:
Prog
ressiveAISin
anadult
Scoliosis
Parameters:22°lumbar
curve
Co-m
orbidIllness:N
APrescribed
BraceWear:NA
Primaryoutcom
e:NPRSandQPD
SSecond
aryoutcom
e:NA
Num
berof
F/U:6
Leng
thof
F/U:
T1=1mon
thT2
=5mon
ths
T3=7mon
ths
T4=9mon
ths
T5=12
mon
ths
T6=24
mon
ths
Mainfinding
:The
NPRSredu
ced
from
8.5at
T0to
2.0at
T6.The
QPD
Sredu
cedfro
m43
atT0
downto
15at
T6.
Additiona
lfinding
s:NA
Statisticalsig
nifican
ce:N
ABracecompliance:Patient
adhe
redto
theprescribed
treatm
entanditwas
well
tolerated,
andthepatient
was
comfortablewith
theuseof
theorthosis.
Harmsassociated
with
bracing:
Noadverseeven
tsrepo
rted
.
Palazzoet
al(2017)
[28]
Design:Retrospe
ctivecoho
rtstud
yBraceType:Rigid
TLSO
TradeNam
e:Vesine
tMaterial:Plastic
Proposed
MOA:
NA
Additiona
lTreatment:NA
Region
:France
Samplesize:38
Age:61.3(SD=8.2)
Sex:Female
Diagn
osis:
9prog
ressiveidiopathic
scoliosis,29
dege
nerativescoliosis
Scoliosis
Parameters:49.6°(SD=17.7)
Co-m
orbidIllness:N
APrescribed
BraceWear:Recommen
ded
>6hpe
rday
Primaryoutcom
e:Coron
alCob
bangle
Second
aryoutcom
e:NA
Num
berof
F/U:1
Leng
thof
F/U:
T1=≥5years
Mainfinding
:The
rate
ofcurve
prog
ressionredu
cedfro
m1.28°
(SD=0.79)at
T0to
0.21°
(SD=0.43)at
T1Ad
ditiona
lfinding
s:NA
Statisticalsig
nifican
ce:Linear
mixed
-effectsregression
(p<0.001)
Bracecompliance:4/38
patients
didno
twearthebraceforthe
prescribed
hourseach
day
Harmsassociated
with
bracing:NA
Zainaet
al(2018)
[21]
Design:PilotProspe
ctiveCoh
ortStud
yBraceType:SoftTLSO
TradeNam
e:Peak
ScoliosisBrace
Material:Fabric,elastic,p
lastic
Proposed
MOA:
design
edto
alleviate
chronicpain
second
aryto
scoliosis
inadults
Additiona
lTreatment:NA
Region
:Italy
Samplesize:20
Age:67.8(SD=10.5)
Sex:Female
Diagn
osis:
Idiopathicor
dege
nerative
scoliosis<30°
Scoliosis
Parameters:61.9°(SD=12.6)
Co-m
orbidIllness:3
patientshad
osteop
orosis
Prescribed
BraceWear:2–4hpe
rday
Primaryoutcom
e:Graph
ical
ratin
gscale
Second
aryoutcom
e:Ro
land
Morris
questio
nnaire,C
ore
outcom
emeasuremen
tinde
x,Osw
estrydisabilityinde
x.Num
berof
F/U:1
Leng
thof
F/U:
T1=4weeks
Mainfinding
:Worstpain,b
ackpain,
andlegpain
sign
ificantlyim
proved
from
7.15
to5.85,from
6.55
to5.25,
andfro
m5.65
to3.55,respe
ctively
atT1
Additiona
lfinding
s:Allother
measuresshow
edstatistically
sign
ificant
improvem
entat
T1except
theOsw
estrydisability
inde
xscores
which
remaine
dstableat
T1Statisticalsig
nifican
ce:Pairedt-test
(p<0.05)fortheprim
aryou
tcom
eBracecompliance:Allpatientswere
compliant
with
theprescribed
hours
ofbracewear
Harmsassociated
with
bracing:All
buton
epatient
repo
rted
satisfaction
with
thebracesaying
they
felt
moresupp
orted
Avg
Average
,F/U
Follow-up,
MOAMecha
nism
ofAction,
NPR
SNum
erical
pain
ratin
gscale,
QOLQua
lityof
life,
Que
becPa
inan
dDisab
ility
Scale,
SDStan
dard
Deviatio
n,T0
Baselin
e,T[X]
=Fo
llow-uppo
int[X]e.g.
T3Fo
llow-uppo
int3,
TLSO
Thoracolum
bosacral
orthosis,V
ASVisual
analog
uescale,
VPRS
Verbal
pain
ratin
gscale,
°=Deg
rees
(Cob
ban
gle)
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 7 of 12
combination of these two groups (20 [6%]). The diagno-sis was not clearly specified or simply termed adult scoli-osis in 225 (66%) participants. Most studies includedfemale participants only [6, 21, 25–29]. Female partici-pants made up at least 78% of the overall sample. Thesex of 56 participants was not clearly defined in onestudy [30]. The mean age provided for participants inthe cohort studies ranged from 41 to 68 years, and theage of participants in the case reports ranged from 37 to65 years. Studies involved participants who were receiv-ing treatment in either France [19, 20], Germany [6, 25,29, 30], or Italy [21]. In the studies that detailed the pri-mary curve type, the curve distributions were: thoracic7%; double major curves 13%; lumbar/thoracolumbarcurves 24%; and lumbar curves 57%. The mean curvemagnitude in the cohort studies ranged from 37 to 50°(Cobb), and curve magnitude in the case reports rangedfrom 22 to 56° (Cobb). The median figure for the initialminimum number of hours of brace wear prescribed was4 h per day (Interquartile range = 3.5 h). One study [27]instructed the participants to wear the brace as required,and two studies [6, 26] did not specify an initial brace wearprescription. The most commonly used material for therigid braces was polyethylene [6, 19, 20, 29, 30]. Mostbraces [6, 19, 20, 25, 27, 29, 30] were designed with thestated intention of improving the physiological alignmentof the spine in the coronal and/or sagittal plane.A variety of outcomes were assessed: pain (measured
using a validated region-specific questionnaire, or painrating scale); Cobb angles; walking distance; progressionto surgery; coronal/sagittal balance; magnitude of ribhump, quality of life; and social functioning. There wasconsiderable heterogeneity between studies with respectto the timing of the final follow-up assessment. Thefinal follow-up in the case reports occurred at 8 weeks[6], 16 months [25] and 24 months [26]. Follow-up datawas collected > 7.5 months after baseline assessment inmost studies. One of the cohort studies [21] however,perfromed the final follow-up at 4 weeks. Three studies[19, 20, 28] captured long-term follow-up data > 5 yearsafter baseline assessment.All studies that assessed pain [6, 21, 25–27, 29, 30]
reported either modest or significant pain reductionafter the application of the brace. There were mixedfindings observed in the studies that tracked Cobb anglein response to bracing [19, 20, 28] revealing that curveseither: improved modestly or significantly (> 5° [Cobb]);failed to progress; or progressed at a slower rate, com-pared to previous known rates of progression, after be-ing braced. In some participants, curves progressedsignificantly (> 5° [Cobb]) despite being braced [19, 20].A similar mixed pattern of responses was seen in thestudies that tracked clinical outcomes e.g. sagittal bal-ance. Significant functional improvement was noted in
patients from three of the case studies [6, 26, 27]. Animprovement in symptoms, to the extent that the bracewas no longer required in some patients, was noted intwo studies [19, 30].With respect to harms/adverse events, participants
from one study [28] reported ‘discomfort’ associatedwith bracing that was temporary and alleviated withbrace adjustment. Only three studies [20, 26, 28] madeexplicit mention of data pertaining to harms/adverseevents. Clinical and statistical heterogeneity combinedwith poor reporting quality hampered the pooling of re-sults and the creation of standardized scores for themain outcomes addressed in this study. All of the cohortstudies included in this review were based on clinicalpopulations with no control-cohort included. For thisreason, each of the six cohort studies were considered tohave a high risk of bias. All case studies are classified aslevel four evidence and are known to be associated witha high risk of bias. A summary of the risk of bias assess-ment is presented in Table 2.
DiscussionThe aim of this study was to review the literature on theefficacy of bracing for adults with scoliosis. To the au-thors’ knowledge, this is the first systematic review tospecifically examine the influence of bracing in this sub-group of the population. The findings of this reviewwould suggest that bracing may be effective, in theshort- to medium-term, for reducing pain and improvingfunction in some adult patients. There is insufficient evi-dence to support the use of bracing for other clinicaloutcomes e.g. Cobb angle. The proposed mechanism ofaction put forward by the authors of the included studieswas that bracing would improve physiological spinalalignment. This type of thinking corresponds withDubousset’s ‘cone of economy’ theory [31], and alignswith the current evidence on the consequences of aber-rant coronal and sagittal balance [32, 33]. Interestingly,while improvements in Cobb angle, rib hump and sagit-tal/coronal balance were noted in some participants,these changes were not uniform within or across the in-cluded studies. Some participants continued to deterior-ate despite the intervention. There are many possiblereasons for these heterogenous outcomes. The studydesigns employed limit the extent to which potentialconfounding variables such as placebo effect and otherforms of bias could be identified and/or controlled for.Furthermore, with only 389 subjects in total across theincluded studies, the effect size of bracing cannot be de-termined with any great certainty.When interpreting the findings of this review it is
important to note that degenerative change and normalageing contribute to decreased flexibility and increasedstiffness in the adult spine [34]. Spinal stiffness in
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 8 of 12
particular is increased in patients with spinal deformity[35]. Thus, it is plausible that the spine of an adult withscoliosis may be significantly more resistant to the influ-ence of external corrective forces such as those beingexerted by a spinal brace/orthosis. This scenario makesthe goal of restoring normal spinal alignment using anorthosis more challenging in adult populations. The posi-tive results observed in some patients may therefore be
the result of individual differences e.g. anthropometrics. Itis also plausible that very small shifts created by the bracein the x, y and z axes are enough to alter symptomatology,but not sufficient to alter the clinical course of spinal de-formity itself.Some of the between-study differences may be ex-
plained by the fact that several different orthoses wereused in the included studies. In the scoping review
Table 2 Summary of the Risk of Bias Assessment based on the Newcastle-Ottawa Scale (NOS) for the Cohort Studies
Selection Comparability Outcome
Primary Author Year Study Design Study Limitations Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Risk of Bias
Weiss 2006 Prospective cohort study Female participants only, nocontrol cohort, no a priorisample size calculationsdiscussed, no discussionof blinded assessment,poor brace compliance,poor reporting quality
✓ ✗ ✓ ✓ ✗ ✓ ✓ ✓ High
Weiss 2009 Prospective cohort study No control cohort, no apriori sample sizecalculations discussed,no discussion of bracecompliance, no discussionof blinded assessment,poor reporting quality
✓ ✗ ✓ ✓ ✗ ✓ ✓ ✓ High
De Mauroy 2011 Retrospective cohort study Retrospective design, nocontrol cohort, non-blinded assessment, illdefined/non-standardisedfollow-up periods, unableto account for potentialconfounding factors, poorreporting quality
✓ ✗ ✓ ✓ ✗ ✓ ✓ ✓ High
De Mauroy 2016 Prospective cohort study No control cohort, noa priori sample sizecalculations discussed,analysis restricted to asmall compliant subsetof the sample, non-specificdiagnosis used, no discussionof blinded assessment, poorreporting quality
✓ ✗ ✓ ✓ ✗ ✓ ✓ ✓ High
Palazzo 2017 Retrospective cohort study Retrospective design, nocontrol cohort, femaleparticipants only, noblindedassessment, unable toaccount for potentialconfounding factors
✗ ✗ ✓ ✓ ✗ ✓ ✓ ✓ High
Zaina 2018 Prospective cohort study Pilot study, no controlcohort, very short-termfollow-up
✗ ✗ ✓ ✓ ✗ ✓ ✓ ✓ High
Abbreviations: Q Question, ROB Risk of BiasSymbols: ✓ = Criteria satisfied, ✗ = Criteria not satisfiedNOS Criteria:1) Representativeness of the intervention cohort2) Selection of non-intervention cohort3) Ascertainment of intervention4) Demonstration that outcome of interest was not present at start of study5) Comparability of cohorts on the basis of the design or analysis6) Assessment of outcome7) Was follow up long enough for outcomes to occur?8) Adequacy of follow up of cohorts
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 9 of 12
activities for this study, there were 65 terms identifiedrelating to either brand names or generic names for dif-ferent brace designs. Only six different brands of bracesand one unknown (two soft and four rigid) were repre-sented in this study. At this point in time, there are nostudies that have compared the efficacy of differentbrace types in adult scoliosis patients. It is plausible thatdifferent approaches to bracing may produce differingoutcomes. However, this line of enquiry should naturallybe restrained until more robust evidence can be pro-duced regarding the efficacy of bracing in general foradults with this condition.Hours of brace-wear may also be an important factor
in adults with scoliosis. The number of hours of brace-wear reported amongst participants in the included stud-ies ranged from 2 to 23 h per day (median brace-wearprescription = 4 h, range of brace-wear prescribed = 2–20 h). It is known, in adolescent populations at least, thatbracing outcomes are strongly influenced by complianceto brace-wear prescriptions [36, 37]. There were noobjective compliance monitors (e.g. temperature sensors)used in any of the studies included in this review.Obviously, factors such as curve magnitude, flexibility,and growth potential underpin brace-wear prescriptionsin skeletally immature patients, but a specific dose-response in adults may also exist. Currently there are nodata from which to derive recommendations regardingthis aspect of treatment in adults. In this review, five ofthe cohort studies [19–21, 28, 29] discussed compliance.At the final follow-up, adherence to brace wear prescrip-tions ranged from 24 to 100%. The reasons for non-compliance with brace-wear prescriptions may be quitevaried. In some instances, poor compliance may indicatetreatment success, i.e. the patient no longer feels theneed to use the brace, while other cases of poor compli-ance may point to poor tolerance of the treatment itselfor unwanted side-effects. Weiss et al [29] stated thatspinal braces/orthoses place the patient’s trunk in a fixedposition which can impair movement and restrict certainpostures. This may not be appreciated by certain pa-tients and decisions regarding whether to wear a braceas prescribed are likely based on an evaluation of theburdensomeness versus the perceived benefit. Weisset al [30] stated that brace wear prescriptions in earlierstudies were left up to patient preference and were notsuccessful. This prompted researchers to modify theirbrace-wear prescription to a minimum of 20 h per dayfor the first six months. After that point, it was hypothe-sized that mobilization of the spine would occur whichwould allow for the desired functional improvements inthe spine. Patients could then manage their brace-freeintervals from then on.There are limitations associated with this review.
Firstly, the review protocol was not published on the
international prospective register of systematic reviews(PROSPERO database). Only studies published in Eng-lish were included in this review. The authors acknow-ledge that valuable findings from research reportspublished in other languages may have been omitted inthis review. There is a general paucity of data on theeffects of spinal bracing/orthosis treatment of adult pa-tients with primary de novo degenerative scoliosis orprogressive idiopathic scoliosis. Moreover, the data thatdoes exist comes from a few centers in Europe, andutilizes only a handful of different brace designs, whichcould impact on the external validity of the findingsfrom this review.The majority of participants in the included studies
were female. It is not clear whether the review findingscan be extrapolated to adult males with scoliosis. Adultscoliosis was the stated diagnosis in the majority (66%) ofparticipants included in this review. Different subtypesof adult scoliosis may respond differently to bracing,however this cannot be determined with any great cer-tainty based on the current literature. Furthermore, headto head comparisons between brace types, and bracemanufacturers were not possible in this review due tothe limited research in this field and the clinical andstatistical heterogeneity of the available literature.Although not specifically addressed in this review,
reporting quality in the included studies was poor over-all. This also placed significant limitations on the type ofanalyses that could be performed. Moreover, the risk ofbias assessment highlighted that the studies included inthis review have a high risk of bias, which negatively im-pacts upon the internal validity and hence the certaintyof the findings from these studies. Case studies have ob-vious methodological limitations which translates into ahigh risk of bias in these types of study designs. The ma-jority of cohort studies included in this review werebased on the clinical outcomes of participants receivingbrace treatment for scoliosis. The usefulness of findingsfrom cohort studies that lack a control-cohort is ques-tionable where the exposure-outcome association is be-ing assessed. In this type of design, there is no way ofdetermining how the exposed cohort compares with asimilar non-exposed cohort in terms of outcomes. Somestudies with relative short follow-up times have been in-cluded in this review. Given the size of the literature onspinal brace/orthosis treatment for adults with scoliosis,the authors decided to summarise all the available stud-ies and associated outcomes, acknowledging that thederivation of more precise and robust estimates of treat-ment effect and duration/timing of such effects will onlybe possible when better quality studies become available.Despite the importance of this type of research, a re-
view of all the international clinical trial registries high-lights that our knowledge on bracing for adult scoliosis
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 10 of 12
is unlikely to change in the near future due to a lack ofplanned research in this area. Twenty international trialregistries were searched using the terms scoliosis orspinal deformity. Of the 867 results retrieved, only threeof these pertained to bracing in adult populations. Onetrial [21] has been completed and was included in thisreview, and recruitment is ongoing in the remaining twostudies (ClinicalTrials.gov Identifier: NCT03332277 andNCT03572855).There is a clear requirement for high-quality research
into spinal brace/orthosis treatment for adults with scoli-osis. Randomised controlled trials involving a direct com-parison between braced and non-braced participantswould provide the most robust findings in this regard,however blinding of participants would be difficult. Ifcohort studies are to be used to better understand theinfluence of bracing in adult scoliosis they should: be pro-spective in nature; include an adequate and representativesample consisting of both cases and matched controls;have clearly defined diagnoses; utilize standardizedpatient-centered clinical and radiographic outcomes; andassess these outcomes at short, medium and long termfollow-up points. The authors should also make use of ap-propriate guideline documents for the reporting of studyfindings where available e.g. STROBE statement [38].
ConclusionThere is evidence to suggest that spinal brace/orthosistreatment may have a positive short – medium term in-fluence on pain and function in adults with either pro-gressive primary (de novo) degenerative scoliosis orprogressive idiopathic scoliosis. At this point in time theevidence is of low quality and relates predominantly tofemale patients with thoracolumbar and lumbar curves,and has been based on samples drawn predominantlyfrom Europe. More granular statements regarding theefficacy of different brace types or manufacturers, or theeffect of this therapy has on different curve types cannotbe determined based on the current literature. Properlyconstructed prospective trials are clearly required to bet-ter understand the efficacy of bracing in adult scoliosis.
AppendixSearch String for the PubMed database(((artbrace OR boston brace OR milwaukee brace OR cer-vicothoracolumbosacral orthosis OR charleston bendingbrace OR charleston bending brace OR cheneau braceOR cmcr brace OR corset monocoque carbone respectatla respiration OR ctls OR derotation brace OR dynamicderotation brace OR elastic brace OR gensingen braceOR long brace OR low profile brace OR LSO OR lumbo-sacral orthosis OR lyon brace OR milwaukee brace ORnight over-correcting brace OR night time brace OR nyrcsmart brace OR ober scoliosis brace OR soliman kallabis
harness OR orthosis OR over corrective brace OR pasbOR peak brace OR progressive action short brace ORprovidence brace OR rigid brace OR rigo-cheneau braceOR rosenberger brace OR schol brace OR scoliosis activitysuit OR scoliosis brace OR schol smart activity suit ORsforzesco brace OR short brace OR short detorsionalbrace OR sibilla brace OR soft brace OR spinecor ORsport brace OR super rigid brace OR suspension braceOR thoracolumbar lordotic intervention brace OR thora-columbosacral orthosis OR three point scoliosis braceOR tli brace OR tlso OR triac OR tripoint scoliosisbrace OR wcr brace OR wilmington brace OR woodcheneau brace OR wood cheneau rigo brace))) AND((scoliosis OR degenerative lumbar scoliosis OR denovo scoliosis OR adult spinal deformity OR degenerativescoliosis OR primary degenerative scoliosis OR progressiveidiopathic scoliosis OR secondary degenerative scoliosisOR spinal deformity))) AND ((adult OR geriatric ORelderly OR aged OR aged, 80 OR over OR young adultOR middle aged)).
AbbreviationsLAT: Lateral; LSO: Lumbosacral orthosis; NOS: Newcastle-Ottawa Scale;PA: Posteroanterior; PDS: Primary (de novo) degenerative scoliosis;QOL: Quality of life; SOSORT: Society on Scoliosis Orthopaedic andRehabilitation Treatment; TLSO: Thoracolumbosacral orthosis
AcknowledgmentsNot applicable.
Authors’ contributionsJMc and BTB designed the study. JMc, JMe, AF, JDP, and BTB collected andanalysed the data. BTB wrote the manuscript. JMc, JMe, AF, JDP, and BTBwere involved with reviewing and editing the final manuscript. All authorsread and approved the final manuscript.
FundingThere was no funding received for this project.
Availability of data and materialsThe datasets used and/or analysed during the current study are availablefrom the corresponding author on reasonable request.
Ethics approval and consent to participateNot applicable.
Consent for publicationNot applicable.
Competing interestsJMc is the owner and director of a company that provides treatment andeducational products for practitioners, and patients with scoliosis. JMe, AF,JDP, and BTB are employees of the same company. JMc is the creator of thescoliosis orthosis (Not included in this review). There are no other conflicts ofinterest declared.
Author details1Sydney Scoliosis Clinic, Kirk Place, Level 5, Suite 5.08, 15 Kensington St,Kogarah, NSW 2217, Australia. 2Melbourne Scoliosis Clinic, Ground Floor,Suite 3, 492 St Kilda Road, Melbourne, VIC 3004, Australia. 3School of Healthand Biomedical Sciences, RMIT University, Bundoora, VIC 3083, Australia.4Department of Chiropractic, Macquarie University, North Ryde, NSW 2109,Australia.
McAviney et al. BMC Musculoskeletal Disorders (2020) 21:87 Page 11 of 12
Received: 21 November 2019 Accepted: 27 January 2020
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