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Cost-effectiveness of two dry needling interventions for plantar heel pain: A secondary analysis of an rct

Abstract

Plantar heel pain is a common cause of foot pain that affects patients’ quality of life and represents a significant cost for the healthcare system. Dry needling and percutaneous needle electrolysis are two minimally invasive treatments that were shown to be effective for the management of plantar heel pain. The aim of our study was to compare these two treatments in terms of health and economic consequences based on the results of a published randomized controlled trial. For this, we evaluated the costs from the point of view of the hospital and we carried out a cost-effectiveness study using quality of life as the main variable according to the Eq-5D-5L questionnaire. The cost of the complete treatment with dry needling (DN) was €178.86, while the percutaneous needle electrolysis (PNE) was €200.90. The quality of life of patients improved and was translated into +0.615 quality-adjusted life years (QALYs) for DN and +0.669 for PNE. PNE presented an average incremental cost-effectiveness ratio (ICER) of €411.34/QALY against DN. These results indicate that PNE had a better cost-effectiveness ratio for the treatment of plantar heel pain than DN. Fernández, D.; Al-Boloushi, Z.; Bellosta-López, P.; Herrero, P.; Gómez, M.; Calvo, S.

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Cost-effectiveness of two dry needling interventions for plantar heel pain: A secondary analysis of an rct

Author: Fernández, D.; Gómez, M.; Herrero, P.; Calvo, S.; Al-Boloushi, Z.; Bellosta-López, P.
Year: 2021
DOI: 10.3390/ijerph18041777
Source: https://zaguan.unizar.es/record/99711/files/texto_completo.pdf
In e na ional Jou nal o
En i onmen al Resea ch
and Public Heal h
A icle
Cos -E ec i eness o Two D y Needling In e en ions o
Plan a Heel Pain: A Seconda y Analysis o an RCT
Daniel Fe nández 1, Zaid Al-Boloushi 2,3, Pablo Bellos a-López 1, Pablo He e o 3,* , Manuel Gómez 1
and Sand a Cal o 1


Ci a ion: Fe nández, D.; Al-Boloushi,
Z.; Bellos a-López, P.; He e o, P.;
Gómez, M.; Cal o, S.
Cos -E ec i eness o Two D y
Needling In e en ions o Plan a
Heel Pain: A Seconda y Analysis o
an RCT. In . J. En i on. Res. Public
Heal h 2021,18, 1777. h ps://
doi.o g/10.3390/ije ph18041777
Academic Edi o : Son Nghiem
Recei ed: 25 Decembe 2020
Accep ed: 8 Feb ua y 2021
Published: 12 Feb ua y 2021
Publishe ’s No e: MDPI s ays neu al
wi h ega d o ju isdic ional claims in
published maps and ins i u ional a il-
ia ions.
Copy igh : © 2021 by he au ho s.
Licensee MDPI, Basel, Swi ze land.
This a icle is an open access a icle
dis ibu ed unde he e ms and
condi ions o he C ea i e Commons
A ibu ion (CC BY) license (h ps://
c ea i ecommons.o g/licenses/by/
4.0/).
1Facul y o Heal h Sciences, Uni e sidad San Jo ge, Campus Uni e si a io, Au o . A23 km 299,
Villanue a de Gállego, 50830 Za agoza, Spain; [email p o ec ed] (D.F.); [email p o ec ed] (P.B.-L.);
[email p o ec ed] (M.G.); [email p o ec ed] (S.C.)
2Minis y o Heal h, S a e o Kuwai , Jamal Abdulnasse S ee , Al Solaibeykha A ea 5, Sa a ,
Kuwai Ci y 13001, Kuwai ; [email p o ec ed]
3
Physia y and Nu sing Depa men , Facul y o Heal h Sciences, Za agoza Uni e si y, C/Domingo Mi al s/n,
CP 50009 Za agoza, Spain
*Co espondence: phe e o@uniza .es
Abs ac :
Plan a heel pain is a common cause o oo pain ha a ec s pa ien s’ quali y o li e
and ep esen s a signi ican cos o he heal hca e sys em. D y needling and pe cu aneous needle
elec olysis a e wo minimally in asi e ea men s ha we e shown o be e ec i e o he managemen
o plan a heel pain. The aim o ou s udy was o compa e hese wo ea men s in e ms o heal h
and economic consequences based on he esul s o a published andomized con olled ial. Fo his,
we e alua ed he cos s om he poin o iew o he hospi al and we ca ied ou a cos -e ec i eness
s udy using quali y o li e as he main a iable acco ding o he Eq-5D-5L ques ionnai e. The cos
o he comple e ea men wi h d y needling (DN) was
€
178.86, while he pe cu aneous needle
elec olysis (PNE) was
€
200.90. The quali y o li e o pa ien s imp o ed and was ansla ed in o
+0.615 quali y-adjus ed li e yea s (QALYs) o DN and +0.669 o PNE. PNE p esen ed an a e age
inc emen al cos -e ec i eness a io (ICER) o
€
411.34/QALY agains DN. These esul s indica e ha
PNE had a be e cos -e ec i eness a io o he ea men o plan a heel pain han DN.
Keywo ds:
d y needling; pe cu aneous needle elec olysis; cos -e ec i eness analysis; plan a heel
pain; quali y o li e
1. In oduc ion
Plan a heel pain (PHP) is a common cause o oo pain and discom o ha a ec s he
quali y o li e (QoL) o pa ien s. The equency and incidence o PHP is unce ain; howe e ,
i is es ima ed ha o e he cou se o a li e ime, 10% o he popula ion migh su e om
his condi ion [
1
,
2
]. PHP places a ela i ely la ge bu den on public heal h, being a ai ly
common cause o ou pa ien isi s [
3
] and medical expenses, wi h cos o PHP ea men
es ima ed o be be ween $192 and $376 million in he Uni ed S a es [4].
Clinical p ac ice guidelines ecommend he use o conse a i e ea men o PHP
managemen , such as join and so issue mobiliza ion o sel -s e ching home p o-
g ammes [
5
]. In pa icula , sel - s e ching home p og ammes we e shown o be e ec i e
o add essing PHP [
6
]. Fu he mo e, ecen andomised clinical ials (RCTs) showed
ha he e is an addi ional e ec o educ ion o pain se e i y when sel - s e ching home
p og ammes a e combined wi h manual he apy [
7
]. I was also shown ha d y needling
(DN) is e ec i e o managing PHP, al hough he magni ude o he ea men e ec should
be conside ed agains he equency o mino ansi o y ad e se e en s [8].
DN and pe cu aneous needle elec olysis (PNE) a e wo minimally in asi e ea men
modali ies ha we e shown o be e ec i e o PHP managemen , educing he mean and
maximum pain since he i s ea men session, wi h long las ing e ec s [
9
]. Despi e he
In . J. En i on. Res. Public Heal h 2021,18, 1777. h ps://doi.o g/10.3390/ije ph18041777 h ps://www.mdpi.com/jou nal/ije ph
In . J. En i on. Res. Public Heal h 2021,18, 1777 2 o 9
inc eased use o hese ea men modali ies in ecen yea s in clinical p ac ice, o he bes o
ou knowledge, no p e ious s udy in es iga ed he cos -e ec i eness o PNE and DN on
PHP. Mo eo e , in he case o PHP, we only ound a s udy analysing he cos -e ec i eness
o o he in e en ions, such as he use o oo o hosis [10].
The e o e, he aim o his s udy was o compa e he cos -e ec i eness o wo al e na-
i e in e en ions, DN and PNE, in e ms o heal h and economic consequences.
2. Ma e ials and Me hods
2.1. S udy Design
The p ima y s udy was a andomised con olled ial ca ied ou du ing 2018 and
2019, o compa e he e ec i eness o wo needling in e en ions, conduc ed a he Physical
Medicine and Rehabili a ion Hospi al in Kuwai . The s udy was conduc ed in compliance
wi h he Helsinki Decla a ion o Human Righ s and e hical app o al was ob ained om
he Medical E hics Commi ee o he S a e o Kuwai Minis y o Heal h, wi h e e ence
numbe 642/2017 and egis a ion a Clinical ials.com, numbe NCT03236779, a ailable a
h ps://pubmed.ncbi.nlm.nih.go /30683124/ (accessed on 15 Decembe 2020).
This seconda y s udy used he e ec i eness da a ob ained in he RCT o pe o m a
cos -e ec i eness s udy.
2.2. Pa icipan s
Pa icipan s we e included in he andomised con olled ial i hey ul illed he ol-
lowing c i e ia. (1) Diagnosed wi h PHP in acco dance wi h he Clinical Guidelines linked
o he In e na ional Classi ica ion o Func ion, Disabili y and Heal h om he O hopaedic
Sec ion o he Ame ican Physical The apy Associa ion. (2) Aged 21 o 60 yea s a admission
o he s udy, acco ding o he Kuwai i E hical Commi ee. (3) A his o y o PHP o o e one
mon h, showing no imp o emen s wi h p e ious conse a i e ea men . (4) The abili y o
walk 50 m wi hou any suppo . (5) The p esence o myo ascial igge poin s on plan a
and cal muscles based on an ini ial physical examina ion ca ied ou by a physio he apis
wi h expe ience and aining in myo ascial igge poin s. (6) Accep ing ea men om a
male physio he apis . (7) The abili y o unde s and he s udy and gi e in o med consen ,
as well as ha ing signed he consen o m. The exclusion c i e ia we e—(1) needle phobia;
(2) needle alle gy o hype sensi i i y o me als; (3) he p esence o coagulopa hy o use o
an icoagulan s acco ding o medical c i e ia; (4) he p esence o pe iphe al a e ial ascula
disease; (5) p egnancy; (6) de ma ological disease a ec ing he d y needling a ea; (7) he
p esence o any ch onic medical condi ion ha migh p eclude pa icipa ion in he s udy,
such as malignancy, sys emic in lamma o y diso de s (e.g., heuma oid a h i is, pso ia ic
a h i is, ankylosing spondyli is, sep ic a h i is), neu ological diseases, polyneu opa hy,
mononeu opa hy, and scia ica; (8) ea men o PHP wi h needling o acupunc u e du ing
he las ou weeks; (9) his o y o injec ion he apy in he heel o e he p e ious h ee
mon hs; and (10) p e ious his o y o oo su ge y o ac u e.
2.3. In e en ion Condi ions
The in e en ion condi ions we e es ablished du ing he RCT. All pa icipan s signed
he in o med consen and we e andomised o he DN o PNE g oup in blocks o 10 pa ien s.
Alloca ion was andomly assigned using a compu e p og am (Randomize , h ps://
www. andomize .o g/ (accessed on 14 Janua y 2018)) wi h andom pa ien ile numbe
sequences gene a ed by a hi d pe son no in ol ed in he s udy. Each pa icipan ecei ed
ou indi idual physical he apy sessions consis ing o DN o PNE, once a week, using
speci ic DN needles (Agu-pun , Ba celona, Spain) [
9
]. The du a ion o each session was
app oxima ely 30 min. DN and PNE in e en ions we e pe o med exac ly in he same
way, wi h he only di e ence being ha he needle was connec ed o he PNE equipmen
du ing he PNE p ocedu e (“Physio In asi a” equipmen PRIM S.A. Mad id, Spain) o
add a gal anic cu en o he mechanical e ec o he needle. Du ing he i s session,
all pa ien s we e ins uc ed in a sel -s e ching p o ocol [
7
] ha was pe o med wice a
In . J. En i on. Res. Public Heal h 2021,18, 1777 3 o 9
day. An independen blinded assesso conduc ed all assessmen s a baseline, 4, 8, 12,
26, and 52 weeks o ollow-up. Quali y o li e (QoL) da a we e used o pe o m he
cos -e ec i eness analysis.
2.4. Cos s
The economic e alua ion was made e ospec i ely and om a hospi al pe spec i e.
F om his, di ec heal hca e cos s we e calcula ed, such as he ma e ial used o pe o m
he needling (s e ile gauze, disin ec an , needles), PNE equipmen , and he cos o he
physio he apy and physia is sessions. To assess he cos o PNE equipmen , wo scena ios
we e calcula ed. In one scena io, he o al cos o he equipmen was included in he cos
o he s udy, calcula ing he o al numbe o sessions ha we e ca ied ou in ou s udy
and he o al cos o he equipmen was di ided by he numbe o sessions. In he second
scena io, he a e age numbe o uses ha he equipmen can ha e in a s anda d clinic pe
yea and he amo iza ion o he cos o he equipmen in a sho pe iod o h ee yea s
was calcula ed.
The cos o he physia is and he physical he apy was ob ained om he bulle in
“Cos analysis and pe o mance e alua ion o go e nmen heal h se ices o he Kuwai
Minis y o Heal h” (Financial a ai s, Budge and Con ol Depa men —Cos Accoun ing
Sec ion) [
11
]. Cos s o usual ca e we e no conside ed o compa ison as he pa icipan s
selec ed we e en olled on he basis ha he s anda d ea men o PHP was no e ec i e
(see inclusion c i e ia).
2.5. Ou comes
EQ-5D-5L was comple ed a baseline, 4, 8, 12, 26, and 52 weeks o each pa ien . This
ques ionnai e included i e dimensions—mobili y, sel -ca e, usual ac i i ies, pain/discom o
and anxie y/dep ession, wi h i e le els o se e i y, which made i e en mo e obus han
p e ious e sions [
12
]. To ob ain he quali y-o -li e alue based on he EQ-5D ques ionnai e
da a, he ‘EQ-5D-5L Index Value C osswalk’ ool was used wi h English p e e ence weigh s.
Using he s udy iming, i was possible o ob ain he quali y-adjus ed li e yea s (QALYs), which
was he p e e ed measu e o heal h ou comes o use in echnology app aisals. QALYs we e
es ima ed o each subjec using a ea unde he cu e analysis.
2.6. S a is ical Analysis
The s a is ical analysis was pe o med using IBM SPSS S a is ics (V.25, IBM, Mad id,
Spain) by in en ion o ea , wi h he las obse a ion ca ied o wa d. The dis ibu ion o
he da a was e i ied by he Kolmogo o -Smi no no mali y es and a ac o ial ANOVA
(Bon e oni es ) was pe o med o e alua e he di e ences.
To analyze he unce ain y o QALY and cos s, a p obabilis ic analysis was pe o med
by a ying bo h pa ame e s acco ding o ce ain anges o hei dis ibu ion a iable—
QALY and cos pai s we e boo s apped 1000 imes o achie e 95% con idence in e als [
13
].
To summa ize, his s udy conside ed he p opo ion o boo s ap eplica ions ha ell
below and o he igh o he line o he cos -e ec i eness h eshold. Then, we ep e-
sen ed he inc emen al cos -e ec i eness a io (ICER) in ela ion o possible alues o he
cos -e ec i eness h eshold in he cos -e ec i eness accep abili y cu e (CEAC) [
14
]. To
comple e his sensi i i y analysis, a uni a ia e analysis o o e head cos s was ca ied ou
conside ing ha hey could accoun o up o 30% o he alue o di ec cos s [15].
3. Resul s
A o al o 102 pa ien s wi h an a e age age o 48 yea s we e included in he inal
economic analysis. Pa icipan s we e di ided in wo g oups, wi hou signi ican di e ences
be ween g oups a baseline (Table 1).
In . J. En i on. Res. Public Heal h 2021,18, 1777 4 o 9
Table 1. Demog aphic cha ac e is ics o pa icipan s and o he baseline cha ac e is ics.
DN G oup
N = 51
PNE G oup
N = 51
Gende (male) 15 (29.4%) 15 (29.4%)
Age (yea s) 49.5 (±8.9) 48.1 (±8.8)
Heigh , cm 160.5 (8.2) 161.2 (7.9)
Weigh , kg 87.5 (16.5) 90.8 (15.2)
Body mass index (kg/m2)33.9 (±5.5) 35.1 (±6.4)
Du a ion o symp oms, mon hs 6.0 (6.0) 9.9 (11.5)
Medica ions, n yes (%)
- Neu omodula o s/an iepilep ic 18 (35.3) 22 (43.1)
- Painkille s 16 (31.4) 16 (31.4)
- An i-in lamma o y medica ion 16 (31.4) 17 (33.3)
- Myo elaxan medica ion 9 (17.6) 8 (15.7)
All alues a e means (±s anda d de ia ion) o numbe o pa ien s (%).
All esul s om he o iginal s udy i led “Compa ing wo d y needling in e en ions
o plan a heel pain: a andomised con olled ial” can be ound a h ps://bmjopen.bmj.
com/con en /bmjopen/10/8/e038033. ull.pd .
3.1. Cos s
The DN and PNE ea men cos s e alua ed a e displayed in Table 2. Cos s we e no
compa ed wi h he usual s anda d o ca e cos s as one o he inclusion c i e ia o be en olled
in he s udy was “a his o y o PHP o o e one mon h, showing no imp o emen s wi h
p e ious conse a i e ea men ”.
Table 2. Cos s.
DN G oup Bo h PNE G oup
Sani a y consumables (session) €1.06
PNE equipmen - €2300
Cos o PNE pe session (204 sessions) €12.21
Cos o PNE pe session acco ding o clinic €0.94
Physia is (session) €96.03
Physical he apy (session) €43.65
Cos i s week o ea men €140.74 €146.26 ±€5.64 *
To al ( ou sessions) €178.86 €200.90 ±€22.55
* The a ia ions in he cos o he PNE g oup a e due o he calcula ion wi h o wi hou amo iza ion o he PNE
equipmen .
The cos o sani a y consumables co esponded o he use o glo es, needles, disin-
ec an , and any o he ma e ial associa ed wi h he needling in e en ions. The cos o he
PNE equipmen co esponded o he p ice o he “Physio In asi a” equipmen (PRIM S.A.
Mad id, Spain), wi hou axes. Wi h hese da a, we calcula ed he cos pe session and
asked o eedback om a g oup o expe physical he apis s o closely esemble he eal
alue o he cos o a session wi h PNE in he usual clinical scena io.
To comple e he cos s, i was necessa y o add he cos o he pe sonnel who ca ied
ou he ea men s and hei supe ision. These cos s a e a ailable in he documen “Cos
analysis and pe o mance e alua ion o go e nmen heal h se ices 2013–2014” om he
Kuwai Minis y o Heal h [
11
]. The cos o he physia is and he physical he apy was
In . J. En i on. Res. Public Heal h 2021,18, 1777 5 o 9
conside ed o be he same in bo h g oups. To al di ec cos s o ea men we e
€
22.04 mo e
expensi e in he PNE han in he DN g oup, because o he use o he speci ic equipmen
o p o iding he PNE ea men .
3.2. Quali y o Li e
An imp o emen in QoL was obse ed a weeks 4 and 8 in bo h ea men g oups.
Howe e , he PNE g oup also showed imp o emen s a 52 weeks (Table 3),wi h signi ican
di e ences be ween g oups a 52 weeks (Figu e 1).
Table 3. Mean quali y o li e (QoL) om EQ-5d.
Va iable DN Mean (SD)
DN Mean
Di e ence om
Baseline
PNE Mean (SD)
PNE Mean
Di e ence om
Baseline
Mean Qol
Di e ence
PNE–DN (SD)
QoL (1-0)
Baseline 0.630 (0.230) - 0.669 (0.215) - 0.039 (0.323)
4 h week 0.777 * (0.224) 0.147 0.757 * (0.237) 0.087 −0.020 (0.341)
8 h week 0.721 * (0.232) 0.091 0.737 * (0.230) 0.067 0.015 (0.349)
12 h week 0.641 (0.298) 0.011 0.694 (0.272) 0.025 0.053 (0.370)
26 h week 0.644 (0.287) 0.014 0.722 (0.278) 0.053 0.078 (0.365)
52nd week 0.660 (0.270) 0.034 0.764 * (0.099) 0.099 0.103 ** (0.323)
(±s anda d de ia ion); * di e ence om baseline in means is signi ican p- alue < 0.05; ** di e ence be ween g oups is signi ican .
In . J. En i on. Res. Public Heal h 2021, 18, x FOR PEER REVIEW 5 o 9
To comple e he cos s, i was necessa y o add he cos o he pe sonnel who ca ied
ou he ea men s and hei supe ision. These cos s a e a ailable in he documen “Cos
analysis and pe o mance e alua ion o go e nmen heal h se ices 2013–2014” om he
Kuwai Minis y o Heal h [11]. The cos o he physia is and he physical he apy was
conside ed o be he same in bo h g oups. To al di ec cos s o ea men we e €22.04 mo e
expensi e in he PNE han in he DN g oup, because o he use o he speci ic equipmen
o p o iding he PNE ea men .
3.2. Quali y o Li e
An imp o emen in QoL was obse ed a weeks 4 and 8 in bo h ea men g oups.
Howe e , he PNE g oup also showed imp o emen s a 52 weeks (Table 3), wi h
signi ican di e ences be ween g oups a 52 weeks (Figu e 1).
Table 3. Mean quali y o li e (QoL) om EQ-5d.
Va iable DN
Mean (SD)
DN Mean
Di e ence
om Baseline
PNE
Mean (SD)
PNE Mean
Di e ence
om Baseline
Mean Qol
Di e ence PNE–DN
(SD)
QoL (1-0)
Baseline 0.630 (0.230) - 0.669 (0.215) - 0.039 (0.323)
4 h week 0.777 * (0.224) 0.147 0.757 * (0.237) 0.087 −0.020 (0.341)
8 h week 0.721 * (0.232) 0.091 0.737 * (0.230) 0.067 0.015 (0.349)
12 h week 0.641 (0.298) 0.011 0.694 (0.272) 0.025 0.053 (0.370)
26 h week 0.644 (0.287) 0.014 0.722 (0.278) 0.053 0.078 (0.365)
52nd week 0.660 (0.270) 0.034 0.764 * (0.099) 0.099 0.103 ** (0.323)
(± s anda d de ia ion); *di e ence om baseline in means is signi ican p- alue < 0.05; **di e ence
be ween g oups is signi ican .
Figu e 1. Va ia ion in quali y o li e h oughou he s udy.
Based on he ob ained QoL esul s, ea men wi h DN p esen ed an imp o emen o
+0.615 QALYs while PNE had an imp o emen o +0.669 (di e ence o 0.054) QALYs. The
p obabili y o each al e na i e being cos e ec i e was e iewed using he boo s ap
echnique as a p obabili y sensi i i y analysis.
The cos -e ec i eness a ios o PNE ea men e sus DN inc eased du ing he s udy
pe iod (Table 4).
Figu e 1. Va ia ion in quali y o li e h oughou he s udy.
Based on he ob ained QoL esul s, ea men wi h DN p esen ed an imp o emen
o +0.615 QALYs while PNE had an imp o emen o +0.669 (di e ence o 0.054) QALYs.
The p obabili y o each al e na i e being cos e ec i e was e iewed using he boo s ap
echnique as a p obabili y sensi i i y analysis.
The cos -e ec i eness a ios o PNE ea men e sus DN inc eased du ing he s udy
pe iod (Table 4).

In . J. En i on. Res. Public Heal h 2021,18, 1777 6 o 9
Table 4. Va ia ion o cos -e ec i e a io du ing he s udy.
PNE
Weeks 4 8 12 26 52
% Cos -e ec i e 50% 46% 63% 79% 86%
PNE showed a clea dominance agains DN a 52 weeks, p esen ing e en highe cos s
o he equipmen used (Figu e 2)
In . J. En i on. Res. Public Heal h 2021, 18, x FOR PEER REVIEW 6 o 9
Table 4. Va ia ion o cos -e ec i e a io du ing he s udy.
PNE
Weeks 4 8 12 26 52
% Cos -e ec i e 50% 46% 63% 79% 86%
PNE showed a clea dominance agains DN a 52 weeks, p esen ing e en highe cos s
o he equipmen used (Figu e 2)
Figu e 2. Boo s apped cos -u ili y pai s d y needling (DN) s. pe cu aneous needle elec olysis
(PNE).
The p obabili y ha he PNE ea men a 52 weeks would ha e a be e cos -
e ec i eness a io compa ed o DN was 86%.
The h eshold ha was used o e alua e he implemen a ion o a he apeu ic
al e na i e is usually €25,000. Howe e , in ou s udy, PNE p esen ed an 86% p obabili y
o being mo e cos -e ec i e agains DN a alues much lowe han his h eshold (Figu e
3). Mo eo e , PNE p esen ed an a e age ICER o €411.34/QALY agains DN.
Figu e 3. Cos -e ec i eness accep abili y cu e (CEAC).
The uni a ia e analysis o es ima ed o e head cos s implied an inc eased cos o
€60.27 o he PNE g oup ( o al €261.17) and €53.66 o he DN g oup ( o al €232.52). The
Figu e 2. Boo s apped cos -u ili y pai s d y needling (DN) s. pe cu aneous needle elec olysis (PNE).
The p obabili y ha he PNE ea men a 52 weeks would ha e a be e cos -e ec i eness
a io compa ed o DN was 86%.
The h eshold ha was used o e alua e he implemen a ion o a he apeu ic al e -
na i e is usually
€
25,000. Howe e , in ou s udy, PNE p esen ed an 86% p obabili y o
being mo e cos -e ec i e agains DN a alues much lowe han his h eshold (Figu e 3).
Mo eo e , PNE p esen ed an a e age ICER o €411.34/QALY agains DN.
Figu e 3. Cos -e ec i eness accep abili y cu e (CEAC).
The uni a ia e analysis o es ima ed o e head cos s implied an inc eased cos o
€
60.27 o he PNE g oup ( o al
€
261.17) and
€
53.66 o he DN g oup ( o al
€
232.52). The
In . J. En i on. Res. Public Heal h 2021,18, 1777 7 o 9
esul ing ICER was
€
530.55/QALY, 119.25
€
/QALY mo e han when o e head cos s we e
no conside ed.
4. Discussion
The objec i e o his s udy was o analyze which ea men op ion was mo e cos -
e ec i e o PHP ea men , on he basis ha bo h DN and PNE we e demons a ed o be
e ec i e. Fo his, we conside ed ha a cos -e ec i eness s udy was he bes ool, using
a good e icacy ma ke such as he pa ien QoL and e alua ing all cos s in ol ed a he
heal h cen e. The baseline cha ac e is ics o ou pa ien sample we e homogeneous, and i
was a good s a ing poin o exclusi ely assess he a ia ion due o ea men .
We chose he EQ-5D-5l scale mainly because i was one o he mos used scales, bu
also because i allowed us o make a mo e global assessmen o pa ien heal h s a us.
Compa isons o EQ-5D-5l wi h o he mo e speci ic scales such as he Manches e Ox o d
Foo Ques ionnai e (MOXFQ) concluded ha bo h we e pa icula ly esponsi e o changes
in pain, mobili y and ac i i y, o social in e ac ion ollowing ea men ; bu ‘ he gene ic
EQ-5D may allow compa ison o gene al heal h s a es in he wide heal h communi y’ [
16
].
Howe e , i has a d awback when i comes o ans e ing he da a om he ques ionnai e
o QoL, as cu en ly, he e is no p ede ined c osswalk index o Kuwai i pa ien s. In
communica ion wi h Eu oQol g oup expe s, i was conside ed ha he mos alid op ion
could be o use he B i ish alues.
Ou analysis showed an imp o emen o he QoL in bo h g oups o almos 0.1 poin
on he EQ-5D-5l scale. The esul s ob ained by Rome e al. [
10
] wi h he use o an ac-
commoda i e oo o hosis o unc ional oo o hosis we e 0.07 and 0.09 QALY/yea ,
espec i ely. I we compa e he QALY alues gained wi h DN ea men (0.615) and PNE
(0.669) agains hese esul s, we see ha he e was a conside able imp o emen wi h hese
needling ea men s.
Rega ding cos s, only hose ha mos in luence a clinic, hospi al, o a heal h cen e
we e conside ed in e ms o equipmen and s a . In bo h cases, he cos o he equipmen
was assessed as he consumable ma e ial ha was used and enewed o each pa ien and
session. The p ice o he PNE equipmen migh ha e di e ences depending on he b and
o he coun y whe e i was pu chased. In his case, we only alued he de ice used in his
s udy. To assess he cos o his equipmen o each session as accu a ely as possible, an
a e age o uses pe yea and yea s o amo iza ion was de e mined. On he o he hand, we
also calcula ed he cos in ol ed o each session in case he equipmen was used only o
his s udy (51 pa ien s, 4 sessions o each one; 204 sessions). The cos wi h he a e age o
annual uses and amo iza ion seemed o be he mos ealis ic since his equipmen could
be used in many o he pa hologies.
On he con a y, being among he i s o pe o m cos analyses o his ype o ech-
niques migh lead o ce ain limi a ions, such as he di icul y o assessing he indi ec cos s.
In his s udy, we used as a e e ence he inclusion o indi ec cos s, ep esen ed by a la ge
weigh in he o e all e alua ion o cos s, which migh bias he esul s [
17
]. The use o
RCT da a e ospec i ely did no allow us o ob ain mo e in o ma ion o indi ec cos s and
he e o e we did no include hem o a oid he dis o ion o esul s.
The e we e imp o emen s in QoL wi h bo h ea men s, and he di e ences in cos s
be ween ea men s we e ela i ely low. The cos -e ec i eness ela ionships analyzed a e
he boo s apping indica ed ha he e was a clea ad an age o PNE o e DN a 52 weeks.
These esul s mus be in e p e ed wi h cau ion, aking in o accoun he me hodological
limi a ions o ou s udy, mainly ela ed o he sample size, he lack o s udies ha se ed
as a compa ison and he high a e o d op-ou s. In he la e case, and in he same way as
explained in he published s udy “ei he unde powe ing o he in en ion o ea analysis
may explain he inconsis ency o he esul s in he PNE g oup possibly leading o signi ican
esul s in weeks 12 and 26” [9], also in cos -e ec i eness a io.
In . J. En i on. Res. Public Heal h 2021,18, 1777 8 o 9
Howe e , his s udy also had some s eng hs, as i is he i s s udy o ollow a s ic
me hodology in he cos -e ec i eness analysis o wo needling in e en ions and he da a
we e ex ac ed om a andomized con olled ial compa ing hese needling in e en ions.
This was he i s ime ha a s udy compa ed he ea men cos s o DN and PNE,
which combined wi h he cos -e ec i eness analysis ca ied ou . This could be help ul o
bo h adminis a o s and clinicians o assess he inclusion o new ea men me hods in
hospi als o ehabili a ion clinics.
5. Conclusions
Al hough bo h DN and PNE we e ound o be e ec i e in imp o ing QoL o PHP
managemen , PNE ea men was mo e cos -e ec i e han DN, wi h signi ican di e ences
a 52 weeks. In he compa isons made acco ding o he cos -e ec i eness analysis, his
ansla ed in o an 86% p obabili y ha PNE was mo e cos -e ec i e compa ed o DN a
52 weeks. Conside ing he limi a ions o ou s udy based on he loss o pa ien s om he
p e ious s udy and he lack o eliable indi ec cos s, u he s udies a e needed o e i y
he di e ences in PNE and DN.
Au ho Con ibu ions:
Concep ualiza ion: D.F., Z.A.-B., M.G., and P.H.; me hodology, D.F. and M.G.;
o mal analysis, D.F., Z.A.-B., P.B.-L., S.C., P.H., and M.G.; da a cu a ion, D.F.; w i ing—o iginal
d a p epa a ion, D.F., Z.A.-B., P.B.-L., and S.C.; w i ing— e iew and edi ing, D.F., P.B.-L., P.H.,
and M.G.; supe ision, P.H. and M.G. All au ho s ha e ead and ag eed o he published e sion o
he manusc ip .
Funding: This esea ch ecei ed no ex e nal unding.
Ins i u ional Re iew Boa d S a emen :
The RCT s udy was conduc ed acco ding o he guidelines
o he Decla a ion o Helsinki, and app o ed by he Medical E hics Commi ee o he S a e o Kuwai
Minis y o Heal h, wi h e e ence numbe 642/2017 and egis e ed a Clinical ials.com, numbe
NCT03236779, a ailable a h ps://pubmed.ncbi.nlm.nih.go /30683124/.
In o med Consen S a emen :
In o med consen was ob ained om all subjec s in ol ed in he
RCT s udy.
Da a A ailabili y S a emen :
Da a will be a ailable on easonable eques by email o Daniel
Fe nández ([email p o ec ed]).
Acknowledgmen s:
We would like o acknowledge E a Ma ía Gómez-T ullén and Mohammad
A ian as hei p e ious wo k allowed us o pe o m his seconda y analysis.
Con lic s o In e es : The au ho s decla e no con lic o in e es .
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