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Changes in pain perception after pelvis manipulation in women with primary dysmenorrhea: a randomized controlled trial

Abstract

Objective. This study aims to evaluate the immediate effect of a global pelvic manipulation (GPM) technique, bilaterally applied, on low back pelvic pain in women with primary dysmenorrhea (PD). Design. A prospective, randomized, double-blind, controlled trial. Setting. Faculty of Nursing, Physiotherapy and Podiatry. University of Sevilla, Spain. Methods. The sample group included 40 women (30 ± 6.10 years) that were divided into an experimental group (EG) (N = 20) who underwent a bilateral GPM technique and a control group (CG) (N = 20) who underwent a sham (placebo) intervention. Evaluations were made of self-reported low back pelvic pain (visual analog scale), pressure pain threshold (PPT) in sacroiliac joints (SIJs), and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels. Results. The intragroup comparison showed a significant improvement in the EG in the self-perceived low back pelvic pain (P = 0.003) and in the mechanosensitivity in both SIJs (P = 0.001). In the between group comparison, there was a decrease in pain perception (P = 0.004; F(1,38) = 9.62; R2 = 0.20) and an increase in the PPT of both SIJs, in the right side (P = 0.001; F(1,38) = 21.29; R2 = 0.35) and in the left side (P = 0.001; F(1,38) = 20.63;R2 = 0.35). There were no intergroup differences for catecholamines plasma levels (adrenaline P = 0.123; noradrenaline P = 0.281; dopamine P = 0.173), but there were for serotonin levels (P = 0.045; F(1,38) = 4.296; R2 = 0.10). Conclusion. The bilateral GPM technique improves in a short term the self-perceived low back pelvic pain, the PPT in both SIJs, and the serotonin levels in women with PD.

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Changes in pain perception after pelvis manipulation in women with primary dysmenorrhea: a randomized controlled trial

Author: Molins-Cubero, Silvia; Rodríguez Blanco, Cleofás; Oliva Pascual-Vaca, Ángel; Heredia Rizo, Alberto Marcos; Boscá-Gandía, Juan J.; Ricard, François
Publisher: Oxford University Press
Year: 2014
DOI: 10.1111/pme.12404
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Ti le:
Changes in Pain Pe cep ion a e Pel is Manipula ion in Women wi h P ima y
Dysmeno hea: A Randomized Con olled T ial
Au ho s and a ilia ions:
Sil ia Molins-Cube o, PT, DO,*
Cleo ás Rod íguez-Blanco, PT, DO, PhD,†
Ángel Oli a-Pascual-Vaca, PT, DO, PhD,†
Albe o M. He edia-Rizo, PT, PhD,†
Juan J. Boscá-Gandía, PT, DO,*
F ançois Rica d, DO*
* Depa men o Physical The apy, Facul y o Nu sing, Physio he apy and Podia y,
Uni e si y o Se illa, Se illa, Spain
† Mad id Os eopa hic School, Mad id, Spain
* Co esponding au ho :
Cleo ás Rod íguez-Blanco,
Depa men o Physical The apy. Facul y o Nu sing, Physio he apy and Podia y,
Uni e si y o Se illa, c/ A icena s/n, Se illa 41009, Spain.
Tel: (+34) 954486528; Fax: (+34) 954486527;
E-mail: [email p o ec ed].
Abs ac
Objec i e. This s udy aims o e alua e he immedia e e ec o a global pel ic
manipula ion (GPM) echnique, bila e ally applied, on low back pel ic pain in women
wi h p ima y dysmeno hea (PD).
Design. A p ospec i e, andomized, double-blind, con olled ial.
Se ing. Facul y o Nu sing, Physio he apy and Podia y. Uni e si y o Se illa, Spain.
Me hods. The sample g oup included 40 women (30 ± 6.10 yea s) ha we e di ided
in o an expe imen al g oup (EG) (N = 20) who unde wen a bila e al GPM echnique
and a con ol g oup (CG) (N = 20) who unde wen a sham (placebo) in e en ion.
E alua ions we e made o sel - epo ed low back pel ic pain ( isual analog scale),
p essu e pain h eshold (PPT) in sac oiliac join s (SIJs), and he endogenous esponse o
he o ganism o pain ollowing ca echolamines and se o onin elease in blood le els.
Resul s. The in ag oup compa ison showed a signi ican imp o emen in he EG in he
sel -pe cei ed low back pel ic pain (P = 0.003) and in he mechanosensi i i y in bo h
SIJs (P = 0.001). In he be ween g oup compa ison, he e was a dec ease in pain
pe cep ion (P = 0.004; F(1,38) = 9.62; R2 = 0.20) and an inc ease in he PPT o bo h
SIJs, in he igh side (P = 0.001; F(1,38) = 21.29; R2 = 0.35) and in he le side (P =
0.001; F(1,38) = 20.63;R2 = 0.35). The e we e no in e g oup di e ences o
ca echolamines plasma le els (ad enaline P = 0.123; no ad enaline P = 0.281;
dopamine P = 0.173), bu he e we e o se o onin le els (P = 0.045; F(1,38) = 4.296;
R2 = 0.10).
Conclusion. The bila e al GPM echnique imp o es in a sho e m he sel -pe cei ed
low back pel ic pain, he PPT in bo h SIJs, and he se o onin le els in women wi h PD.
I shows no signi ican di e ences wi h a sham in e en ion in ca echolamines plasma
le els.
Key Wo ds. P ima y Dysmeno hea; Manipula ion Spinal; Pel ic Pain; Pain Th eshold;
Se o onin; Ca echolamines.
In oduc ion
P ima y dysmeno hea (PD) is a common gynecological diso de in women o
childbea ing age [1,2]. PD is de ined by se e al symp oms ha p ecede mens ua ion, in
he absence o any o ganic pa hology, and las ing a ound 48–72 hou s [2]. The mos
common symp om is pain in he lowe abdomen ha adia es o bo h highs o o he
lumba -sac al egion. Pain is usually accompanied by less equen signs and symp oms,
such as i edness, headache, nausea, cons ipa ion, and dia hea [3,4]. The p e alence o
PD a ies be ween 45% and 95% o women o childbea ing age [4,5]. I is a common
cause o absen eeism om wo k o school, hus in e e ing wi h daily li e and
wi h many social cos s a ising om his [5].
The e ha e been many p oposals o in e en ions o PD in he scien i ic li e a u e. As
pel ic pain seems o be media ed by p os aglandin ac o 2Å~ [6], he mos common
he apeu ic app oach has been medical ea men ha usually in ol es he
adminis a ion o nons e oidal an i-in lamma o y d ugs (NSAIDs) o o al con acep i es
[7]. On one hand, NSAIDs a e pe iphe al inhibi o s o p os aglandin syn hesis [8]. On
he o he hand, o al con acep i es inhibi o ula ion and, consequen ly, he endome ium
educes in hickness he eby diminishing p os aglandin syn hesis [7].
The e iciency o hese ea men s a ies be ween 17% and 95% [4]. Howe e ,
pha macological ea men may in ol e some ad e se side e ec s, like gas oin es inal
bleeding, which inc eases hei in ole ance o some pa ien s [4,9]. Hence, i is common
o women o demand new and al e na i e he apeu ic ools wi h less pe cei ed
associa ed isks [10].

P e ious esea ch has analyzed he e ec s on pel ic pain pe cep ion a ising om PD
h ough al e na i e he apies such as: 1) con inuous low-le el opical hea a hypogas ic
le el [11]; 2) acupunc u e [12–14]; 3) anscu aneous elec ical ne e s imula ion
(TENS) and in e e en ial cu en [15]; 4) homeopa hy [16]; 5) Chinese he bal medicine
[17]; 6) acup essu e [18,19]; and e en 7) low a die s [20,21]. Many o hese he apies
ha e p o en o ha e a posi i e impac on pain. Howe e , hese esul s a e no
conclusi e enough o ecommend hei use ou inely, due o poo me hodological
designs in some cases [10,22].
Se e al s udies ha e e alua ed he e icacy o spinal manipula i e echniques on women
wi h PD [23–26]. Spinal manipula ion (SM) has p o en o ha e some in luence on pain
pe cep ion and mens ual c amps, and also on plasma le els o some chemical
media o s o pain [26–28]. E en hough he e a e no conclusi e obse a ions o p o e a
posi i e e ec o SM on pain associa ed wi h PD, he e is a lack o ag eemen on which
spinal egion needs o be manipula ed and on he echniques ha may be mos e ec i e.
Hence, he e is some need o de elop new s udies in his ield [29]. Hol zman e al. [25].
p oposed ha SM should be di ec ed o speci ic es ic ions in he lumba -sac al spine
(L5-S1) o alle ia e pain associa ed wi h PD.
Hypo hesis
The global pel ic manipula ion (GPM) echnique, bila e ally applied in women
su e ing om PD, imp o es pain pe cep ion on low back pel ic egion and has a
posi i e impac on he endogenous esponse o he o ganism o pain (ca echolamines
and se o onin elease in blood le els).
Objec i e
Based on he neu ophysiologic e ec s o SM echniques [30], he main aim o he s udy
is o assess he immedia e e ec s o a GPM echnique in low back pel ic pain
pe cep ion and in se e al nocicep i e bioma ke s in subjec s wi h PD.
Ma e ials and me hods
Design and Randomiza ion P ocedu e
A andomized, by means o a andomized numbe able designed by an In e ne websi e
(h p://www. andomized.o g), and double-blind con olled clinical ial was conduc ed.
The andomiza ion sequence was gua ded by an ex e nal consul an who gua an eed i s
concealmen om all pa icipan s in he s udy: subjec s, e alua o s and he apis in
cha ge o he in e en ions.
Pa icipan s
One hund ed (N = 100) pa icipan s who had a his o y o low back pain and medical
diagnosis o PD by a gynecologis , excluding any o he gynecological pa hology,
we e ec ui ed o he s udy. The clinical eco ds we e selec ed om he main
esea che ’s p ac ice. Six y women (N = 60) we e excluded om he s udy; 37
(N = 37) did no mee he inclusion/exclusion c i e ia, 14 women (N = 14) e used
pa icipa ion, and nine (N = 9) o hem we e excluded o easons ela ed mainly o ea
o blood ex ac ion o home add ess changes. Du ing he alloca ion phase, 40 (N = 40)
subjec s who en olled he s udy we e dis ibu ed in o wo g oups (N = 20). No losses
o ollow-up we e eco ded du ing da a collec ion and analysis phases [31] (Figu e 1).
Es ablished inclusion c i e ia we e: 1) age be ween 18 and 50 yea s old; 2) diagnosis o
PD acco ding o he P ima y Dysmeno hea Consensus Guideline [32]; 3) egula
mens ual cycle (28 ± 7 days); 4) mens ual pain o mode a e o se e e in ensi y (o e
50 mm in he isual analog scale [VAS]); and 5) subjec s who ga e he in o med
consen .
Exclusion c i e ia we e he ollowing: 1) o ha e an in au e ine de ice; 2) being
diagnosed as su e ing om seconda y dysmeno hea; 3) p e ious gynecological
in e en ions; 4) con aindica ions o he GPM echnique; 5) ha ing ecei ed p e ious
manipula i e ea men wi hin he 2 mon hs be o e he beginning o he s udy; and 6)
showing any s ess o ea o SM.
Sampling P ocess and Sample Size
The subjec s we e selec ed acco ding o nonp obabilis ic con enience sampling
echniques. The sample size was based on a pilo s udy [33], using he so wa e “ amaño
de la mues a 1.1”® (Hospi al Uni e si a io San Ignacio, Bogo á, Colombia). Taking
in o accoun a one- ailed hypo hesis, he in e g oup di e ence being o 20%, o an
α alue o 0.05, a a iabili y o 15%, a desi ed powe o 90%, and o an expec ed
a e age o 25% in he expe imen al g oup (EG) and o 5% in he con ol g oup (CG), a
sample size o 20 subjec s pe g oup was necessa y. The inal sample g oup consis ed o
40 women wi h PD wi h a mean age o 30 ± 6.10 yea s (19–48). They we e di ided in o
an EG (N = 20) and a CG (N = 20). The s udy ecei ed app o al and was designed
con o med o he guidelines o he Ins i u ional E hical Commi ee. I has been
egis e ed in he Aus alian and New Zealand Clinical T ials Regis y wi h egis a ion
numbe ACTRN12611001195943.
Blinding
All pa icipan s we e in o med o he gene al aspec s o he s udy wi h he in o med
consen o m (possible bene i s, isks, p ecau ions and side e ec s o he assessmen s,
and he in e en ions). They we e old be o e andomiza ion ha di e en ypes o
ea men s will be compa ed in he s udy. Subjec s and e alua o s who collec ed
o analyzed da a emained unawa e o he ea men alloca ion g oup and he speci ic
aims o he s udy o gua an ee pa icipan and ou come assesso blinding. The
he apis in cha ge o he manipula ion (in e en o ) did no pa icipa e in he
assessmen p o ocol. Measu es we e also aken o ensu e ha he in e en o emained
unawa e o he ea men alloca ion g oup (in e en o blinding).
S udy P o ocol
Subjec s we e con ac ed by phone. Once i was con i med ha hey quali ied unde he
inclusion/exclusion c i e ia and hei willingness o pa icipa e, hey we e e e ed o he
s udy se ing he i s day o he mens ual cycle. Then, he subjec comple ed he
in o med consen pape , which was p epa ed in acco dance wi h he Decla a ion
o Helsinki ( e sion 2008), and illed he pe sonal and clinical da a o m. The
measu emen p o ocol ook place in a oom equipped wi h a ea men able and a
s eady empe a u e be ween 18°C and 21°C. All e alua ions we e pe o med in bo h
g oups be o e and a e he in e en ion in he ollowing o de .
Assessmen o Low Back Pel ic Pain
A VAS was used o measu e sel - epo ed pain. VAS is conside ed o be a alida ed,
e ec i e, accu a e, sensi i e, easy o use, and ep oducible me hod o assess acu e
and ch onic pain [34]. The subjec ma ked on he VAS he cu en in ensi y o low back
pel ic pain. The esul was exp essed in millime e s (mm), anged om 0 mm o
100 mm.
Assessmen o P essu e Pain Th eshold (PPT) in Sac oiliac Join s (SIJs)
PPT is de ined as he minimum amoun o p essu e needed o e oke discom o o pain
[35]. A digi al dynamome e (PCE, FM model 200, Meschede, Ge many) was used o
which makes i di icul o ind solid conclusions.
In ega d o plasma le els o nocicep i e bioma ke s, Degenha d e al. [27] ound no
signi ican changes o se o onin le els a e os eopa hic manual he apy (OMT) in
subjec s wi h low back pain. This esul sugges s ha he e ec s o he OMT wi hou
applying HVLA echniques may no be media ed by he se o one gic pa hway bu
p obably by endogenous opioids and cannabinoids. On he con a y, Skyba e al. [28]
demons a ed in an animal model ha join manipula ion augmen s he se o onin
concen a ion, which can p oduce analgesia h ough he descending inhibi o y pa hway.
When compa ing be ween-g oups, we obse ed a signi ican inc ease o se o onin
concen a ion in he EG. I may be easonable o s a e ha his esul is due o he
dec ease ound in he se o onin le el in he CG (14.93 Å} 36.58 ng/mL), because he
inc ease in he EG le el was small (4.98 ± 22.51 ng/ mL). We ind no de ini e
explana ion o hese esul s in he CG. Some s udies ha e shown no s a is ical changes
on ni ic oxide concen a ion blood le els a e al e na i e he apies (yoga and
acup essu e) in women wi h PD [51,52]. I emains an issue o u u e s udies o
complemen he p esen e alua ions wi h he assessmen o ni ic oxide le els a e SM.
I may help o ge a be e unde s anding o he clinical e ec o manipula i e
echniques in PD.
Limi a ions
The s udy has ce ain limi a ions. Fi s , he subjec ’s in ake o NSAIDs and/o cyclo-
oxygenase-2 speci ic inhibi o s was no con olled. This could be a plausible
explana ion o unde s and he baseline in e g oup di e ences in he pe cei ed pain. I
could be also a gued ha he in ake o o al con acep i es, which has been ela ed o
pel ic pain alle ia ion [7], was highe in he EG (25% o subjec s).

Low-back pel ic pain seems o be associa ed wi h hype mobili y, s ain o he join s,
and body mass index [50]. Pa icipan s’ heigh and weigh we e no measu ed in his
ial. Unlike p e ious esea ch [23,25], no e alua ion o speci ic lumba -sac al mo ion
es ic ions was pe o med ei he . Second, he indings mus be cau iously in e p e ed
because he s udy has only assessed immedia e e ec s. Long- e m esul s should be
e alua ed in u u e s udies [53]. Finally, he measu emen o ca echolamines and
se o onin plasma le el is complex because i is in luenced by ood in ake, s ess, and
pa ien posi ion, and i shows a ci cadian hy hm [54]. Subjec s we e always placed
du ing measu emen s in a si ing posi ion, and hey we e a es be ween each blood
ex ac ion. The s udy was always pe o med be ween 8:00 PM and 9:00 PM o a oid
in luencing he baseline le els. Howe e , i any woman had a ea o SM o blood
ex ac ion and ailed o epo such eeling, ca echolamines le els may ha e been
al e ed in he pos in e en ion e alua ion.
Conclusions
The GPM echnique, bila e ally applied o women wi h PD, appea s o inc ease
signi ican ly he PPT in he SIJ and educe he sel - epo ed low–back pel ic pain in a
sho e m.
Rega ding he plasma le els o chemical modula o s o pain (ca echolamines and
se o onin), he GPM echnique inc eases se o onin le els, wi h a small e ec size. I
shows no s a is ical signi icance in compa ison wi h a sham (placebo) in e en ion o
ca echolamines plasma le els.
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Figu e 1. Flowcha diag am acco ding o CONSORT s a emen o he epo o
andomized con olled ials.
Figu e 2. Global pel ic manipula ion echnique.
Whi e a ows indica e he impulses’ di ec ion.