se\zere fibromyalgia paiients

84 The Joumal of OrthopaedicMedicine Vol l6 1994 No 3
TREATMENT OF CONSECUTI\M
SE\ZEREFIBROMYALGIA PAIIENTS
WITH PROLOTHERAPY
K DEANREEVESMD
KansasCity,Kansas
ABSTRACT
The potentisl of tendon and ligarpDt trtgg€rs ,s prinrary
trocic€ptors in libromyslgia l€d to tretrhnent of primry
fibromyalgia pstients wlth t€ndon .nd ligsment
strerythening Wection. Trigger iniection of tigam€nt and
tendon wlth prolif€rant (TILT therapy or prolothempy)
oflers th€ adyantageof creatlng incr€rsed sftength of th€
conn€ctive tissue in the regiD of i4jection rs well as
affecting the pain cycle. Reductlotr in pain levels and
incrcased frrnctional abillti€s w€re se€nin eK€ss ol 75% of
patienb with s€vere fibromyslgir in this study. The
implicrtions of this for further study arc consider€d.
INTRODUCTION
The searchfor'centlal facto$' in thecauseoffibromyalgia has
revealedcvidenceof possiblealtorationof pain modulationin
thebody sucbasadeffeasein circulatingserotoninandpossibly
antibodiesthat block s€rotoninrec€ptors.,! Evid€nc€has
also been found for central factors affecting soft tissue
homeostasis.(Possibleglucoconicoid deficiency or deficient
ploductior of gowlh hormonerclarcd faclorsrri!.) S€arch
continuesfor the primary nocicoptorin fibromyalgia. It i;
notabletbatthe classicaltenderpointr in fibromyalgiaareover
tenalon
andliganent insertioos.Semi€lastictissuesaregenerally
recognircdto betbesitesofacutedamagein sprainard strain.!
Tendonandligamentattachments
1operiost€umhavefte lowest
parn thresboldof any deep somatic slructure.l Inman and
Saunalers
reportedstimulatingperiosteumin a variety of ways
includingFessure,andelicitedsevererefenedpain to muscles
or bony prominencesin tbe referal zone in reproducible
patlems.?rDeValer4 Gorrcll, Ilackett,Kelgreo,Kraus,l,eriche,
and Travell have all described referal pain from
tendinoligamentouss!:uctures,with pattens of referal most
tsz:i:e 40.1112Tendonor
melicdously s€t out by Hackett.3.D
ligamentlaxity or weaknesshasbe€nproposedto causechronic
nociceptionvia inadequateskeletalsuplort, ifltemittent sfetch
of fixed-length sensoayfibres, or developmentof myofas€ial
mgge. points.lqs The F€mise of this studyis that weakor lar
tenabnsor ligarnen8arc p,otentialnociceptonin fibromyalgia
and that tbis is potentially a correctablenociceptor source,
Prolotherapyinvolvesinjecthg an areaof ligamentor tendon
laxity or weaknesswith a solution that stimulatesfibroblast
proliferation. The goal of prolifefttion therapyis to restore
normal conngctivetissuelengli and stength in $e affected
area,and in so doing to restff€ adequateskeletalsuppo( and
eliminatesourcesof myofascialtrigger per?etuation.tBordan
demomtratedthe ability of a simpledextrosesolutionin 12.5%
concentxation
ormorcto cr€le aprcmptinflanmatoryreaction.6
The simpleal€xtosesolutionis thought0ocreateirritation by an
osmoticgradient, Cells in tbearcalo6ewater,anddessicateto
the point of an injury response,Animal studiesbav€showna
,[0% increasein diameter and strength of injected tendons
comparedtocontralaienltendons.raszChalges
persistedmote
than 12 monthspost injection and were not (hpendenton any
differencein exerciselevelsofthe animals.Humansodies have
demons8aEdcollagenfilre diameterincrcasesand incaoas€d
cellularity on biopsy of injected areas. Disability, range of
motion, and pain levels all imFov€d signilicandy in patients
injectedaft9r5ormffe yearsofcbronicpain,26 In humanknees
with reproducibleligamental laxity as measuredby a
computerizedknee analysisdevi{r, a staristically significant
reductionin ligarnentallaxity wasai€monstrated
with a P value
lessthan0.05.31Randomizeddouble-blindcontrolstudieswilh
salineinjededcontrolshavedemonstratod
statisticallysEnilicant
imprcvementsin low backpain atrddisability rating in tealod
patientscomParedto confols.ux
METHOD
Pati€ntPopulation
Consecutivepatienls with severefitromyalgia were lreated
with tendoMigamentsbengthening
injection. Thefi bromyatgia
wassufficiently severcin eachcasethatall thepatientsdesired
inlervention trial, All patients had expeden€d continuous
upperbody,back,andlower bodypainfor morethan6 months,
with avoragedumtion 7 yea$ and 10 months. Tenderpoinis
werepresentin at least7D classicregionson bottrsidcsof the
body. Functionalquestionnaires
indicatedthat377,hadregular
narcotjc intake, sexual function was limited in 487.. arm
numbnessmadehandlingsmallobjectsdifficult in 55%,70%of
patientshadtrolay downdudngl}e dayducto pain,lifting arms
overheadinc.eased pain fu 10% of patients. and bending,
twisring andsquattingfrequendywas intolerableto moretlan
80%of thepatients. Awakeningfrmr painaveraged3.I times
p€r night. Sitting toleranc€was33 minules;standingtoleranc€
27 minules; light wmk blerance 45 minut€s; heavy work
toleranc€19minutes;and writing tolerancel7 minutes.
TheJoumalof OrthoDaedic
MedicineVol 16 1994 No 3 85
Solutlon us€d
The solutionusedwasmadeby combining3ccof 50%dextose
with 2ccof I 7. xylocaine(lignocaine)and7ccofbenzyl alcohol
tlpe baclariostaticwater,making a dextroseconcenfation of
was12.5E".
Typicalfirstsosion
Therc are seyeral 'melbods' of prolotberapy,and two
reFesentativgtextscanh referenceilfor details.ezBecauseof
the very diffuse numb€r of painful entheses,lhe method of
injeclion was the meaiculousone of Hacketr.45 A tlTical
cornprehensive
firsl injectionsessionfd upperandlower body
includedthe following numbersand sites of injections,with
0.5cco 0.75ccinjectedat eacbsite,assumingbothsidesof lie
b(dy treatmentin almost all potential injection siles. Semi,
spinalis,spleniusandrectuscapilusinsertionson baseof sk[ll
(24); c€rvicalfac€t ligaments(14) ; c€rvic€]intertransversarii
(28); posteriorsuperiortrapeziusinsertionson backof clavicle
(8); laieral cGtoransverseligament attacbmentto ribs (14);
infraspinatus,teresmajor and minor attachmenlsto scapulae
posleriorly (28); scsleneattacbmentsant and post tubercles
( 16);subscapularis,
bicepsanalpectoralisinertions on anterior
potion of humerus (16); comtrlon extensorattachmenbaa
elbo*(6); lumbar inlertansvenarii (10) ; lumbar facets(10):
lumbosacraljunction(6 with severalneedleredirections); Cresa
of iliun (6); iliolumbar ligament (4 with several needle
redirections);SI ligament(6 wilh sevemloeedleredir€ctions);
gluteusmaximus,mediusandminimusinsertionson iliac bone
(30); deeparticularligamentsof hip (6 with seveul neodleredirections);exlemal mtator and gluteii attacbmenlsposterior
trochanter(24);disraladductorattachmenrs
knee(2); hamstring
afiachmentsin ansednebl]rsa(16). It canhmerjiately bo s€en
thatthisis atime consumingandexactiogprocedurcwh€ndone
conprehensively-Tbe volumeof solutionusedcantle asmuch
as 200ccwith treatrnent,but the concenhationof Xylocaine in
Oe solutlon of less than .27,, coupledwith the lenglh of the
procedurecausesno problemsin lermsof snaeslhetictoxicity.
Sedation
Oral vistaril (hydroxlzine) wasusedfor nauseaprophylaxisto
avoialftre anaphylaxiswith compazine. An anaesfteticgun
wasusedto numbthe skin in all paiienti who Feferfed it to the
neealleinsertionsenMtion.lntravenousdemerol(p€$idine)was
usedas the exclusivesedalioocxcept for thosewith demerol
allergy or witi prolongednauseaafter demcrol use. Valium
(diazepam)wasaddedor us€dexclusivelywhendemerolwas
not f4sible asa soleagent.Continuousoximety wasusedwith
anoffice attenalantpres€nt
b ensureoximetryvaluosabove8?%
anallegular b(eathingpattems. Narcan(naloxone)was
ifimediately available. lt is important 10 nole that dememl
shouldbe titrateJ in 25-50mginqem€nts for lust one 0otwo
s€ssions.Carofulrecordkeepingsbouldallow delemination of
ialealarnountsfor scalationby session3- Oximetry or close
observationof beathing parcms was consideredparticularly
critjcal witb useof 40mg of demerolor morein the elderly or
?5mgormore in the young. Demerolwastitratedwith first the
firsl oneto two sessionsto determinethepatients'reaclionand
carefirl recordskept as to ideal amountsfor futu{e reference.
Note thatthereasonfor significantamountaof demerolwasthe
substantialtime periodrequirEdfor comprehensiveinjection.
Inioction lollow-up
Becauseof healingcascadelenglbof 8 weeks,follow-ups were
schedulcd
at lhat inerval in gene€1.dough orberpain area.
may havebeenlrcaled in the interim. At follow,up, pain areas
andpalpationdeterminedarcasof injection. All soreareasto
palpationwerenol reinjected but ratherpotentialtrigger areas
for currEntpain wereaddrcssed.Patientsreceivedan average
of 1.5 injeclion.e'srons
to an) paniculdrpainrcgion.
Qu6stionnaire us6
Questioonaireswere senl out to all patientswho hadreceived
one or more trealrncnts,with the fust treatrnent occuning at
leasl6monthsbeforequestionnairenuiling. This questionnaire
askedaboutpainleveh pre' andposf treatnentby bodyregion.
Otherquestions
requesled
frcqucncyand
assessmentolovcrall
intensity of pain, and lolcranceof sitring. standing,walking,
sleeping,light worh andheavywork. Patien6werealsoasked
to compafetendonliganent strengtbeninginjection to other
lJcatmentsthey had received in the past, and asked aboul
complications.If questionnaires
were nol retumed follow-up
'phonecontactcotrfilmed if one was receivcd,and thc palienl
wasencouragedto fttum iie questionnailE,'Phoneinterviews
were decidedagainstto avoid leadinglhe answers. 3l of 40
consecutive fibromyalgia patients returned follow-up
questionnair€s,
or 78E of the patientsso treated.
RESULTS
Table1d€pictstheaveragepainlevelsofthe 3l patienlsby are&
usinga 10pointscalewith '10'theworstpainimaginable
and
'0' beingno pain at all ever. Thc 16regionschosenwererated
ar 4.86 out of 10 pre-injection
for a
and 3.30posl-injec(ioo
reduction
of32.1%.A1lregionsof thebodywerenotedto have
lessaveragepain after injecdon.
Tabta1
Painb€forsandatterertendon/ligamenl
sl16ngth6ning
injsclion(prolotherapy)
86 TheJoumalof fthoDaedic ModicineVol 16 1994 No 3
Table 2 depicts the funclional outcomeof injection- 2U3l
patientsindicatedtheir pain frequencywasb€tter,muchb€tter
or gone, and 18/31 indicated&eir Dain intensity was better,
muchbetter,or nooe,Thoquestronnai&askedforan€xplanation
of 'worse' or lnuch worse' responses,witb rcasonsgiven of
\ue\\ in J/5.workin 15. needinglofollow-up$ilh
norn.urance
in 2/5,anddon'tknow in U5. Two oflhesepatienbhadonly one
feaunen(. Improvementin sitting, standrng,walking and
sleepingability in minu(eswas noGdto be aboutthe sane for
each. Of parhcularintereslfrom a functionalpoint of view was
that of the 30 patientsindicatingproblemswith tol€ratinglight
work, 18indicat€dtheywerebetteror muchb€tterat tolerating
lighi work and 2 indical€dthey tolelatedligbt work less.The
results\rere not sofavouable for heavywork, with 9 indicating
they toleratedheavywork b€tler and6less. The 6 indicating
they were wone again gave "stress", "work", "bad 1o stop
treamenf'. or "don'tknow" asthe reasoo.
Table3
ol pfololherapy
Comparison
wilhothertfealments
previoLrsly
received
Table4 displaystheir answers.Panicularlynotablewasthatof
thos€not desirjng follow-up at the time of lhe questronnaire
mailing,6 wercbelterorplateaued,two did notspecify,andonly
onethoughtl}€ treatmentwastoo muohto go through.D€spite
the useof sealationandskin anaesthesia
wilh ajet gun,therc is
no way to truly makothis treahent pleasant.Patientloleranc€
of treatmentwas imFessive,however,in thal only 1/31slated
they werenot continuingtreatsnentbecaus€it waskx) muchto
go through. Patientsdid need substantialsuppo( not only
during the areahlentsessionswhich averagedI hour and 30
minu0esin lengtl, but also betweenfeaunentswih questions
thatarise. The implication is that lhis treatmentat lhis level of
intonsily would bo impracticalfor the busy clinician.
Table2
Functional
resullsol ledon/ligamenl
slrenglhening
chang€sposlinjeclion
lniection:
Table 3 providesresultswhenpatientswereaskedto compare
the outcomeof lendonligarnent sEengtheninginjection with
anypRvroustreaEncnrs
the) hddreceived.Tbe) weregivena
s€riesof statemenlsto choosefrom, andasksl to pick &e one
that tlescribedtheh opinion. Nole that all patrents(otherlian
thoseunableto tak€time off work for therapy)wereoffered69 sessionsof physicaldrcrapyfor posturalexercise,stretching
a.d massageinstruction,instructiooin proper heat use,
encouagementto walk,andamitriptylineor flexeril. 2213I had
previously receivedphysical therapy; l4l31 bad previously
receivedmanipulation;6/3 1 acupunctue;and l ?/31 nassage.
Of the 3l patients, 12 hdicated that it was the only really
effectivetreatlnenltheyhadr€ceived,and23 ol 31 indicatedit
wasmorehclpful thanany pastteatn, ent, Paticnlswereasked
to indicatetheirstatuswith respectto fuiule deatment,andwere
siven severalresoonses10choos€from.
Table4
Folow-upplanspostpfolotherapy
TheJoumalof Orthopaedic
MedicineVol 16 1994No 3 87
When patients were asked if they had any significant
complicationso sideeffectsfrom featmenttheyansweredasin
Table 5. Note tha! of what wouid truly b€ considereda
c@plication, om hadsuperficialphlebitisof a veininjectedfor
s€dationpurpos€sandonehada spinalheadache.lt is important
to wam patrentsof temFrary new pains,variablepain periods
after injection, small marks from anostietic guo if it is us€d,
naus€a,
an4 ifinjectionsaregivenoverposteflorribattacbments,
pneumothorax. In this Factitioner's experiencewith this
particularinjection methoda slmptonalic pneumothoraxhas
occurredapproximatelyonceeachyear when injections over
posteriortboraxaveragelm o( moreper day - given the large
numb€rsofinjectionsm eachs$sion couldbesrgnificandyhigh
if theclinician is not trainedin anglesto use,lengthsof needles
to us€,anddepthsofinjcclion. Injectionsof aflerial slructures
arerarcsinceinjectionneveroccu$ unlessboneis touche4and
aspirationoccursin critical areassuchasthenocklaterally. The
amountof anaestheticinjectedat any onetime is substantialy
smallerlhan
lbe$alle{ aflounlr vershowoto causra s(i/ure
or @ssationof respifilion, even with direct vertebralartery
instilladon.r Nerved"m4gehasneverb€enrepoted wiii usoof
dextroseinstillation andgen€rallythin calibre neetuesused.If
electsical sensationoccurs, however, the needle should be
repositioneal,
Table5
Sidestlscts/complicalions
ol prclolherapy
Insevsr€
librcmyalgia
syndrome
A mmplicating factorin follow-up examof thesepatientsis that
tbenumb€rof tondff pointsdiminishedasslmptomsimproved.
Note tbat the 't€ndorpoints' were often injected during the
couneoftreatmenl(iecommonextensorselbow,
distaladduc0ors
knee, cervical paraspinals,coslotransverseligaments,upp€r
rnpezrusr,
DtscusstoN
Thefe is an accumulatingbody of evidencefor p€ripheralsoft
tissuecbangesin fibromyalgia. An exanple would be strong
in tissuecomplianceandreactiveskin
evidencefor an incroa.s€
ht?€remiain nbromyalgia-'3 Searchingin skeletalmusclehas
not yiolded consistentfindings on biopsy, tboughchangesof
degeneration
arc often seen,roBennettpostulatedthata d€fect
processes
in repair
aftermiffo or macrottaumain fibromyalgra
may preventresolutionof such injuries, with developmentof
chronic pathology.3 Recentevidencehas indicatedthat
SonatcmedinC (agrowthhormone-relaledfaclor imporlanlin
musculoskeletalhomeostasis)is deficient in fibrcmyalgia
patients.rNote thatgrowthbormone-relaled
factorsareseseted
primarilydudngstageIV sleepandtba.stageIV sl€€pdisnJbanc€
by alpha waveinttusion is characteristicof fibfomyalgia.lrlr
Jacobsenet al\ finding of somewhatlower levels of Tlpe III
pro$llagen in serumjn libromyalgia patientsis interesting,in
lhalprocollagenis acriticalprecursorin thebealingofmnnective
tissue,?' The healingcascaale
afier s€mi-elastictissuedarnage
is cdticat in mrking the ligamenvtcndonsufficien y dght aftl
thick to continuenormal function. but is time-limited to 2-3
monthsafterinjury, andis dependenton adequacyof fibroblast
density,procollagendeFxition, maturationto collagen,cross
band formation with shoneningof the tendon and ligarnent
laxity.? Injeclion of tendon and ligament triggers, sinc€ il
includes anaes&etic,may be consideredcapable of having
acupunct0reeffectsor effecls on breakingthe pain cycle; but
acupuncturepoints were not specificallytrea0eal
in Ihis study,
and higger injection wilh anaestheticr one has not been
convincingly demons(ratedto be effective in allowing a
sustainable
imFovemgntin functionorpainlevelin thepresence
of wbolebody pain of fibromyalgia.
With respectto the studypatients,th€recanbe li(le doubtthat
(hoy have severefibromyalgia - given sitting and standing
tolerancelcss than30 minutes,bavingto lay down during Ihe
day dueto gdin in 70%, ligbt work lolemnceonly 45 minuies,
andintoleranceofbending,twisring.andsquatting.ln addjlion
the avcragedurationof wbolebody piun of 7 years10monlhs
suggeslsslronglythatspontaneous
remissionsto malkeddegfee
would no( be expectedin this populationandthat spontaneous
wolsening would be at lcast as likely. This is supportedby
kdingham\ longterms(udyshowing97%ofpadentspelsisting
wilb symptorns,857, still fulfilling crileria after 4 yearspost
ons€t,with 60%rating lheir symptomsasworseand26,/0better
than at pres€ntation4 yearspost onscl.ro His sludy included
fibromyalgiapalientswithout severefunctional impajrmcntat
onse(of study. Resultsin this studyof resumingthe healing
in areasofproposedligamenlallaxity indicale3l7, pain
cascade
reduclion. This can mean that tie treafirent is only partially
elTective,that there are perp€tuatingtactors preventing full
resolution, or thal the critical ligamenal laxilics wcre not
addresscd.
Fuflber studiesare unalerway using various combinationsof
ligaments. Functional stalus after treatmenl indicatcs
impmvabilily of painfrequencyandintensity,sitling, standing,
walking and sleeping. Sincefor most fibromyalgia patientsa
keygoalis tokeepworkingwit! theirdisease,18/3I experiencing
improvementin light work ability and 2/31 a worseningis of
particularfunctionalsignificance. The rating of this treatnent
by 22,3I asbetterthananypreviouslyreceivedovertheaverage
7 years of fibrcmyalgia and less effectrve in only 2/31 is
encouragingfbr a potential unique role of Dis trealnenl in
reftactory fibrcmyalgia.
MedicineVol 16 1994 No 3
88 TheJoumalof OrthoDaedic
SUMMARY
The improvementsin pain levels aod funcdonalability after
injection is suppodve of tendonand ligamentsbeing a major
sourceof symptomatologyin fibmmyalgia, In order to make
fhis featmont more practical fuflher shrdiesto detemine $e
reladve importanceof variousligamenvlen&)nn@iceptorsin
fibromyalgiawill be important. In additionit is hopodthat this
stualywill encouragebasic scienceinveshgatorsto futher
researchhomeostasisof connectivetissuein fibromyalgia, as
eveomiqotrauna of daily living in the presenceof impaired
homeostasis
may sufficient to explarnonsetof symptons. The
tendencyof ligamentsandtendonsto refer parnandnumbness
in non-radicula.rpattemsand to inhibit muscularfunction to
crcatesuchsymplonrsas give-way woatnessand a feeling of
non-specificfatigue muld go a long way i0 explaining why
physicians tend to mis-diagnosethes€ patients as having
somatisationdisorder. The lack of evideocefm primary
psychiatricdisordersasthe causefor fibromyalgiabasbeenset
out in the lilerature in a convincing fashion, but until the
$mptomatology of ligament and tendonpatiology is more
widely recognized,the symptomsof fibromyalgiawill remarn
an enigmato mostpracticingphysicians.'
11 Goldsnb€rg
DL Psychologrcal
symptoms
andpsychialric
diagnossln palientswilhlibromyalgiaJnlRhoumatol
198916(Suppl):127130
12 GorrcllRLTroubl€some
ankladisord€rs
andwhatlo do
aboulthem Consullanl1976 16:64-69
GrangasG, LiillgiohnGO Acomparaliv€
sludyol clinical
heallhyafd
signsandlibfonryalgia/tibrosilis
syndrom€,
exarcising
subiects.J Rheumalo 199320(2):344'351
14 GriepEN,Boersma
JW,de-Kloel,ER Aher€dreactivity
ol th€ hypothalamic'pituitary-adr6nal
axlsin th€ primary
fibronryalgia
syndrcmoJ Rh6umalol1993 20(3):469-
17
18
19
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KleinRG,BjornCE,DelongB, MooneyV A randomizsddoubls-b|
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KlausH Clinicallrcalmentof backandneckpainN€w
York,MccrawHill1970 pp95,107
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J, oohertyS, Doh€rty[,4 P marytibromyalgiasyndroms:
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TheJoumalof Orthopaedic
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Rsev€sKD Tschnique
of Prolothsrapy
lnT6d Lennard
LiuYK,TiptonCM,Malh€sRD,6t al An in-situstudyol
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ol a sclerosing
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lllatusrn,PA,L6aand F€biger1994pp pending
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Tis Res 1983 11i95-'102
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H, Scadsbrick
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serotonin
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with
Musculoskel€tal
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1992
fibrorryalgiaYibrositis
syndrcme.
J
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disturbanca
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Trav€llJ Pain[,lschanisms
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155S. l8rh Sl Suit€180,KansasCity,KS 66102
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