Plasma disc decompression compared to physiotherapy for symptomatic contained lumbar disc herniation A prospective randomized controlled trial

Original

research

article

Plasma

disc

decompression

compared

to

physiotherapy

for

symptomatic

contained

lumbar

disc

herniation:

A

prospective

randomized

controlled

trial

Mehdi

Nikoobakht

a

,

Mir

Saeed

Yekanineajd

b

,

Amir

H.

Pakpour

c,d,

*

,

Peter

C.

Gerszten

e

,

Richard

Kasch

f

a_{DepartmentofNeurosurgery,IranUniversityofMedicalSciences,Tehran,IslamicRepublicofIran} b

Department of Epidemiology and Biostatistics, School ofPublic Health, Tehran University ofMedical Sciences, Tehran,IslamicRepublicofIran

c_{Social Determinants ofHealth Research Center,Qazvin Universityof Medical Sciences, Shahid BahounarBLV,} 3419759811,Qazvin,IslamicRepublicofIran

d_{DepartmentofPublicHealth,QazvinUniversityofMedicalSciences,Qazvin,IslamicRepublicofIran} e

DepartmentofNeurologicalSurgery,UniversityofPittsburghMedicalCenter,Pittsburgh,PA,USA f

ClinicandOutpatientClinicforOrthopedicsandOrthopedicSurgery,UniversityMedicineGreifswald,Greifswald, Germany n e u r o l o g i a i n e u r o c h i r u r g i a p o l s k a 5 0 ( 2 0 1 6 ) 2 4 – 3 0

a

r

t

i

c

l

e

i

n

f

o

Articlehistory: Received17July2015 Accepted2November2015 Availableonline28November2015 Keywords:

Containeddischerniation Discdecompression Low-backpain

Minimallyinvasivespinesurgery Plasmadiscdecompression

a

b

s

t

r

a

c

t

Introduction: To evaluate clinical outcomes with PDD as compared with patients who underwenttostandardphysiotherapyintervention.

Materialandmethods: One-hundred-seventy-sevenrandomlyassignedpatientswith primari-ly radicular pain associatedwith a single-level lumbar contained disc herniation were enrolled.ParticipantsreceivedeitherPDD(89patients)orconservativephysiotherapycare (88patients).

Results:PatientsinthePDDgrouphadsignificantlygreaterreductioninlegpainscoresand significantlyimprovedVAS(p<0.001),OswestryDisabilityIndex(p<0.05),and36-Item ShortForm, thanthose inthephysiotherapy groupat 12months. Onsubset analysis, patientsachievedevenbetteroutcomesafterPPDwho:wereyounger,hadashorterperiod ofradiculopathy,ofmalegender,andlowerBMI.Patientswithsubacutepainreportedbetter outcomesthanthosewithchronicpaininthePDDgroup.

Conclusions: Patientselection forPDDoverphysiotherapyfavored youngerpatientswho presentedwithashorterperiodofpainsymptomsandwhohada morefavorablebody habitus.

#2015PolishNeurologicalSociety.PublishedbyElsevierSp.zo.o.Allrightsreserved.

*Correspondingauthorat:SocialDeterminantsofHealthResearchCenter,QazvinUniversityofMedicalSciences,ShahidBahounarBLV, 3419759811Qazvin,IslamicRepublicofIran.Tel.:+982833239259;fax:+982833239259.

E-mailaddresses:[email protected],[email protected](A.H.Pakpour).

Available

online

at

www.sciencedirect.com

ScienceDirect

journalhomepage:http://www.elsevier.com/locate/pjnns

http://dx.doi.org/10.1016/j.pjnns.2015.11.001

1.

Introduction

Lowbackpainistheworld'snumberonecauseofdisability and one of the most prevalenthealth conditions [1]. Most patients also report radicular syndromes [2]. International guidelinesproviderecommendationsoneffectivetreatments forlowbackpain,startingwithconservativeornon-surgical treatment[3].However,aconsiderableproportionofpatients withlumbardischerniationsremainsymptomaticevenafter undergoingconservativetreatments.Epidemiologicalstudies haveshown thattherateof persistentsciatica is1.6% ina givenpopulation[4]whilethisrateincreasesto25%withaging upto64years[5].

Forpatientswhorespondpoorlytoconservativetreatment, surgicaltreatmentmaybeconsidered[6].Theoptimaltiming for surgical intervention is not known [7]. Over the past decade,muchefforthasbeenmadeforminimizationinspinal surgery[8,9].Tothisend,aminimallyinvasivetechniquehas been developed to decrease intradiscal pressure through a percutaneously inserted device placed directly into the intervertebraldiscs.Severalobservationalstudies[9–12]have beenperformedtoassessthesafetyandclinicaloutcomeof thePDDprocedureinthelumbarspineforradiculopathy[13]. Oneprospective,randomized,controlledlumbarwas

identi-fied [13]. The use of PDD technology to treat lumbar

radiculopathyduetoacontaineddischerniationisnotwell supported currently by high-level evidence [10–12,14]. Pro-spective randomized clinical trials with are required to confirmefficacy[10,11].Theaimofthisprospective random-ized controlled clinical investigation was to compare the clinicaloutcomesofpatientswithsymptomaticlumbardisc herniationwhoweretreatedusingeitherconservativetherapy or the PDD procedure. A secondary goal was to better understandtheappropriatepatientforthisprocedure.

2.

Materials

and

methods

The study was designed as a prospective single-blinded randomized controlled trial and was performed between November2010andMarch2012.Itincluded177patientswith lumbosacralradicularsyndromeintwogroups,89patientswho underwentpercutaneousdiscdecompressionusingthePDD technique and 88 patients who underwent conservative treatment.

2.1. Studyprotocol

ThistrialwasapprovedbythelocalEthicalReviewCommittee (No. B38). The protocol was registered with the university committee Trials Registry, number (IUMS-B39). Necessary precautions toprotect the privacy of patients participating in this study were considered. The study was carried out accordingtotheprinciplesofthedeclarationofHelsinki.

2.2. Patients

AllpatientswereselectedconsecutivelyfromtheUniversity Hospitalof Qazvin (ShahidRajaeeHospital, Qazvin).Eligible

patientsincludedthefollowing:agebetween18and70years, had normal neurological function, diagnosisof lumbosacral radicularsyndromebyanattendingneurologist(MN)(achief complaintoflegpain,apositivestraightlegraising(SLR)atless than60degreesreproducingthelegpain,radicularpainscoreof 50orgreaterasmeasuredusinga0-to100-mmVAS;andhadan ipsilateral MRI confirmed disc herniation), contained disc herniation<6mm,withadischeight>50%[15].Allpatients whounderwentpercutaneousdiscdecompressionusingPDDor conservativetreatmentmustpreviouslyhavefirstconservative treatmentforthesamesymptomsforatleast6weeksupto6 months.Patientsmayhaveexperiencedpartialpainreliefwith residualsymptoms,temporalpainreliefornoresponsetothe previouslyconservativetreatmenttobeincludedinthistrail.

Patients wereexcludedfrom thestudyfor thefollowing reasons: patients with more severe axial (back) pain than radicular(leg)pain,sciaticaemergingfrommorethanonedisc level, clinical evidence of cauda eqina syndrome, severe neurologicaldeficits,historyofpreviouslyoperatedsegments atordirectlyadjacenttotheleveltobetreated,radiological evidenceofspinalstenosisorspondylolisthesisatthelevelto betreated,acuteosteomyelitis,spinaltumors,suspectedor plannedpregnancywithinthestudytimeperiod,uncontrolled psychological disorders, and ongoingtreatment for drugor alcohol abuse. All patients with low back pain who were eligibletobeincludedinthestudywereofferedparticipation. Confirming patient eligibility was performed by three independent GPs (i.e. independent researchers). The GPs (asoutcomeassessors)wereblindedtotherandomization.

2.3. Procedures

A statistician not involved in data collection or analysis developed a randomization schedule and produced 177 consecutivelynumberedsealedopaqueenvelopescontaining each participant'sallocation.Randomizationwasperformed usingacomputer-generatedrandomallocationssequence.

Theeligiblepatientswhogavetheirconsentwereaskedto participateinasession.Duringthissession,thenatureofthis studywasexplainedtoallsubjectsalongwithanopportunity toaskquestionsanddecidewhetherornottheywantedto participate.Informedconsentwasobtainedfromallpatients whoagreedtoparticipate.Allpatientswereaskednottotell theoutcomeassessorswhichinterventiontheyreceivedand the outcome assessors were also advised to remind the participantsnottogivethemthisinformation.

Patientswerefollowedatbaseline,1month,3monthsand 12 months after enrollment. Immediately after collecting baselinedatabythesameinitialGPtheallocationenvelope wasopenedbyablindedresearcherwhoguidesthepatients intooneofthetwogroups.177patientswererandomlyassigned intoPDDgroup(n=89)andconservativegroup(n=88).

2.4. Intervention

The percutaneous disc decompression procedure was per-formedbyasingleneurosurgeon(MN)understerileconditions inthelateralpositionfromthesideofpredominantpainusing fluoroscopicguidanceundermoderatesedation,followingthe manufacturer's instructions. Daily activity after PDD was

restrictedinthefollowingway:forthefirst3dayssittingand walkingwaslimitedtoupto10–20minatatime.Nodriving was allowedfor thefirst 2days, and liftingwas limitedto 3–4kgduringthefirst2weeks.

The control group was comprised of patients who were treated with conservative treatment alone. Conservative treatmentwasaimedmainlytoreducepainandconsistedof the following activities: bed rest, active physical therapy, education and counseling with home exercise instruction, spinal manipulation, narcotic analgesics, muscle relaxants, analgesics, and nonsteroidal anti-inflammatory local injec-tions.Physiotherapywasadministeredbysevenexperienced physiotherapistsat5privateclinicsandconsistedof20sessions perpatient overthecourseof 12weeks. Thephysiotherapy stopped if the patients recovered before estimated session. Followingbestclinicalpractice,thephysiotherapytreatments werediversefrompatientstootherpatientsaseachpatient receivedaphysiotherapytreatmentwhichwasappropriatefor theindividualclinicalpresentations.Allphysiotherapistshad MasterofPhysicalTherapy(MPT)andhadworkedfrequentlyon patientswithlowbackpainandspinaldisordersintheirprivate clinics.This non-operativetreatment isconsideredasusual careforpatientswithlumbardischerniation[16].

All patients received a reminder call and diary cards on which to record any side-effects during the follow-up assessments.Patientsinbothtreatmentgroupswereallowed

to receive additional narcotic analgesics, or NSAIDs, at the discretionofthetreatingGP,whorecordedthemedicationinthe patients' records. An independent researcher who was not involved into treatment study analysis and data collection monitoredtheconservativetreatmentsessionstoensurethat allpatientsadheretothetreatment.

2.5. Studymeasures

Theprimaryoutcomesofthestudywerechangesindisability indexandpainwhilethesecondaryoutcomewaschangesin qualityoflifeatbaseline,1month,3monthsand12months afterinitialenrollment.

A self-reported questionnaire was usedto collect socio-demographicvariablesincludingage,gender,workstatusand currentsmokingstatus.Furthermore,herniationlevel, dura-tionofradicularpain,thepreviouslytreatmentandBMIwere takenfrompatients'records.

2.5.1. OswestryDisabilityIndex(ODI),TheShortForm-36, ShortFormMcGillPainQuestionnaire(SF-MPQ)

AnIranianversionoftheODI,SF-36,SF-MPQweretestedon patientswithchronicLBP.TheresultsindicatedthattheODI, SF-36 and SF-MPQ are a reliable and valid instrument to measure functionalstatusinPersian-speaking patientswith LBP[16–18].

Assessed for eligibility N=220 Enrollment N=177 Baseline assessment 88 patients assigned conservative treatment 4 lost to follow-up

5 lost to fol low-up 89 patients

assigned PDD treatment

23 paents refusing to parcipate 20 paents not meeng inclusion criteria

All available data were analyzed: Intention to treat analysis

2.6. Statisticalanalysis

Normality of distribution for everydependentvariable was assessed with the Kolmogorov–Smirnov test and through visualinspectionofthedata.Anindependentttestandchi squarewereusedtocomparepatients'characteristics.

A 2-way repeated-measures analysis of covariance (ANCOVA), with group (conservative, PDD) as the between-subjectsvariable,time(baseline,1month,3monthsand12 months)asthewithin-subjectsvariable,andage,sex,BMIand durationofradicularpainascovariate,wasusedtoexaminethe effects of the intervention. Between-group effect size was calculatedusingPartialEtasquared.Posthocanalyses,with Bonferroni corrections, were appliedinall comparisons. An intention-to-treatanalysiswasperformedincomparingpatient groups.

Allstatisticalanalyseswereperformedbyanindependent biostatistician withSPSSfor Windows version 16.0.Results were considered statistically significant if the p-value was equal to or less than .05 for continuous variables. For percentageoutcomesandnon-parametricvalues,95%con fi-denceintervalswereusedtoshowstatisticalsignificance.

3.

Results

Thisstudyincluded177subjects:89inthepercutaneousdisc decompression(PDD)groupand88intheconservativecare (CC)group.After12months,ninepatients(5.1%oftheoverall patientsstudied)droppedoutof thestudy,fourinthePDD group and five in the conservative group (Fig. 1). Most participants inthis studywere female. All patientsranged from 20 to 70 years of age. Clinical and sociodemographic variables were comparable in both groups (Table 1). At

Table1–Samplecharacteristics.

Characteristic Conservative treatment N=88 PDD N=89 Pvalue Mean,SD Age-years 38.02(8.99) 37.57(7.26) 0.73 Employmentstatus

Fulltimeorparttime 34(38.6%) 25(28.1%) Housekeeper 20(22.7%) 27(30.3%)

Unemployed 34(38.6%) 37(41.6%) 0.28

Sex

Male 43(48.9%) 36(40.4%)

Female 45(51.1%) 53(59.6%) 0.16

Currentsmokingstatus

Yes 56(63.6%) 54(60.7%) No 32(36.4%) 35(39.3%) 0.40 MeanBMIKg/m2 _{25.40(4.15) 26.12(4.53) 0.77} Durationofradicular pain(months) 25.91(8.63) 18.64(12.04) 0.46 Herniationlevel 0.602 L2–L3 3(3.4%) 6(6.7%) L3–L4 19(21.6%) 15(16.9%) L4–L5 21(23.9%) 25(28.1%) L5–S1 45(51.1%) 43(48.3%) Tabl e 2 – Chang es in pain in the co nservatively trea ted and PPD g roups am ong the four time points of obse rvatio n. Baseli ne 1 m o nth follow-up 3 m o nths follow-up 12 mo nths follow-up Time eff ect Time  gr oup effect Con servative PDD Conse rvativ e PDD Con serv ative PDD Conse rvativ e PDD FP hp 2 FP hp 2 Mea n (SD ) Mean (SD) Me an (SD) Mea n (SD) Mea n (SD) Mea n (SD ) Mea n (SD) Mean (SD) VAS scores 7.36 (1.48) 7.60 (1.46) 6.94 (2.27) 5.83 (3.25) 6.60 (2.67) 5.36 (3.43) 6.14 (3.07) 4.68 (3.58) 2.65 0.04 0.015 5.33 0.001 0.03 Present pain intensity 3.63 (1.28) 3.56 (1.27) 3.47 (1.38) 2.90 (1.45) 3.22 (1.50) 2.57 (1.59) 3.10 (1.49) 2.49 (1.66) 21.71 < 0.00 0.110 3.05 0.02 0.017 Sensory 12.21 (5.94) 11.50 (5.89) 11.78 (6.46) 9.50 (6.08) 11.16 (6.18) 8.05 (5.83) 10.35 (5.10) 7.70 (5.86) 15.90 < 0.00 0.08 2.80 0.03 0.02 Affective 4.31 (2.74) 4.24 (2.88) 4.48 (2.41) 3.60 (2.86) 4.32 (2.36) 3.19 (2.75) 4.27 (2.26) 3.16 (1.78) 5.88 0.001 0.03 5.25 0.01 0.03 Total 15.42 (7.46) 14.65 (7.56) 15.00 (7.51) 12.80 (7.28) 14.17 (7.28) 11.08 (7.06) 14.25 (7.26) 10.86 (7.03) 10.52 0.001 0.06 2.60 0.04 0.01 ODI 57.79 (15.61) 56.50 (15.58) 38.75 (13.27) 28.50 (17.02) 36.76 (15.39) 19.87 (15.49) 35.29 (16.43) 10.84 (12.75) 107.47 0.001 0.380 11.52 0.00 0.0 62

baseline,nosignificantdifferenceswereobservedinclinical andsociodemographicvariablesbetweenthetwogroups.

AnANCOVAwasconductedtoexaminemean-levelgroup differencesinVAS across times.The resultsindicatedthat theVASwasreducedsignificantlyacrosstimesinbothgroups (p<0.05).Furthermore,therewasasignificantdifferencein VASbetweenthetwogroupsaspatientswhoreceivedPDD treatmentreportedlowerVASscorethan thoseundergoing conservativetreatment(p<0.001).Distinctreductionsinpain intensity,sensory,affectiveandtotalpainallwereobserved forpatientswhoreceivedPDDtreatment(Table2).

Concerning disability, as assessed by the ODI, repeated measureANCOVArevealedasignificanttimegroup inter-actionforODI[F(1,171)=11.52,p<0.05].Bonferroniposthoc analysis revealed that patients in the PDD group report significantlylowerdisabilitythanthoseundergoing conserva-tivetreatment.

Looking for the ideal patient selection for the PDD procedure, better results were found in younger patients andthosewithashortperiodofradicularpain.Furthermore, beingofmalegenderandlowerBMIwerealsoassociatedwith betteroutcomesincludingVAS,qualityoflifeandODI(Tables 3and 4). Inadditiontothis,patientswithsub-acute (i.e.6 weeksto3months)painreportedbetteroutcomescompared tothosewithpainofchronicduration(Tables3and4).

Differencesinhealth-relatedqualityoflifewereobserved duringfollow-upbetweenthetwogroups(Table5).Physically based subscales of the SF-36 reduced significantly in both groupsacrosstimes(Table5).However,nosignificantreduced changewasseenformentalbasedsubscalesoftheSF-36for eithergroupacrosstimes.PCSrosefrombaselineto12months

in subjects who received PDD (Grouptime interaction: F=3.36,p=.01).

There wereno major complications related to the PDD procedure. Specifically, therewere no cases of infection or nerverootinjury.Nosignificantclinicaladverseeventswere observed in this study with the exception of minor local anesthetic-relatedsideeffects.

4.

Discussion

Inthisstudywedirectlycomparenucleoplasty,a percutane-ous PDD technique, to conservative treatment for patients withsymptomaticlumbardischerniations.ThePDD proce-dure aswell asconservativetreatmentbothgave clinically usefuleffectsontheprimaryoutcomeofVASanddisability. Findings from the secondaryanalyses support theprimary analyses, showing significant positive effects on health-related quality of life especially in physically based SF-36 subscalesbutnotformentalbasedsubscalesoftheSF-36at1,3 or 12 months. However,the PDD grouphad significantly a greaterreductionofpainscoresaswellasbetterSF-36andODI resultsthantheconservativegroup[9].Wefoundespecially youngpatientsandpatientswithashortperiodofradicular painexperiencedbetterpost-interventionalresults[19].Other studiescouldalsoshowbetterresultsinpatientswithashort durationofsymptomsbuttheycouldnotfindthegender,BMI andageeffect[20].

Sofartodateseveralobservationalstudiesoflimitedtofair quality have shown that the PDD procedure is a possibly effective treatmentinmanaging radicularpain forpatients

Table4–Covariatesassociatedwiththequalityoflifeacrosstime.

Age Gender

(malevs.female)

BMI Painduration

(sub-acutevs.chronic) F P hp2 F P hp2 F P hp2 F P hp2 PF 2.76 0.04 0.016 2.47 0.02 0.02 0.861 0.035 0.005 3.09 0.02 0.018 RP 1.47 0.22 0.009 0.72 0.53 0.004 0.255 0.858 0.001 0.451 0.71 0.003 BP 2.59 0.04 0.020 0.219 0.88 0.001 0.26 0.61 0.002 3.60 0.01 0.021 GH 0.59 0.44 0.003 3.08 0.02 0.018 0.582 0.62 0.003 1.66 0.173 0.010 VT 2.69 0.04 0.016 0.28 0.83 0.002 0.73 0.53 0.004 0.24 0.86 0.001 SF 0.50 0.68 0.003 0.68 0.56 0.004 0.74 0.52 0.004 0.59 0.62 0.003 RE 1.263 0.286 0.007 0.972 0.40 0.006 0.436 0.73 0.003 2.610 0.04 0.015 MH 0.183 0.90 0.001 0.252 0.86 0.001 0.43 0.72 0.003 5.31 0.001 0.030 PCS 5.13 0.001 0.030 0.437 0.72 0.003 0.252 0.860 0.001 5.26 0.001 0.030 MCS 0.872 0.455 0.005 1.42 0.23 0.008 0.708 0.54 0.004 3.351 0.019 0.02

Table3–Covariatesassociatedwiththepainanddisabilityacrosstime.

Age Gender

(malevs.female)

BMI Painduration

(sub-acutevs.chronic)

F P hp2 F P hp2 F P hp2 F P hp2

VASscores 4.37 0.005 0.073 4.58 0.03 0.02 9.23 0.001 0.03 3.32 0.02 0.02

Presentpainintensity 4.82 0.005 0.025 3.83 0.008 0.02 4.21 0.03 0.024 4.41 0.004 0.03

Sensory 13.13 0.001 0.07 2.29 0.03 0.02 3.57 0.01 0.02 1.39 0.24 0.008

Affective 5.79 0.001 0.04 5.90 0.001 0.03 2.59 0.04 0.02 4.32 0.013 0.025

Total 9.94 0.001 0.06 3.85 0.01 0.02 4.33 0.04 0.025 13.83 0.001 0.08

withipsilateralcontaineddischerniationwhoarerefractoryto conservativetherapy[9–11,21].Tothebestofourknowledge, this isthefirstrandomized controlledtraillooking forPDD versus conservative treatment in patients complaining of primarilylegpain[11,22].Conservativetreatmentwaschosen tobethecontrolgroup,asthisisthefirsttreatmentoptionin patientswithrefractorysciaticawithorwithoutbackpain.So we comparedthe PDDprocedureresultswitha groupwho receivedoptimalcare[22,23].Whileallpatientswere random-ized totreatmentgroupsduetothe natureof thedifferent interventions in both groups it was not possible to blind participants and healthcare providers from knowledge of whichinterventionaparticipantreceived.Althoughthelackof blinding might be considered as a weakness in the study design,wetriedtoreducethisriskofbias,asallpatientswere treatedaccordingtoastrictprotocol.

Furthermore the outcome assessors were blinded from knowledge of which intervention a participant received. Inclusion criteriaspecifiedthatallparticipants hadtohave afailedconservativetreatment,whichmayhadthepossibility tobiasthestudyinfavorofPDDmethod.Ourresultssupport the literature that PDD is a safe procedure [11,24], as the complicationrateforlumbarnucleoplastywas1.8%[9].

Astheinclusioncriteriaforallpatientsinthenucleoplasty groupwastohavefailedconservativetreatment,thiscould have ledtoabiasagainstthePDDgroup,asthosepatients experienceda significantlylongerduration painsymptoms. Furthermore,thePDDgrouphasahigherVASscoreandpain intensityatbaseline.

Gerszten et al. could show in a randomized controlled clinicaltrailthe superiorityof PDDinterventionover trans-formational epidural steroid injection in patients with an initialfailedtreatmentofepiduralsteroidinjections[13].Inour study functional capacity, measured via ODI, increased according to baseline and in comparison to conservative treatment.Thisissimilartotheresultsofotherstudies[13,24]. Different studies have shown that conservative treatment, includingepiduralsteroid injection,isknownnottohavea painreducinglong-termeffect[25].Thismightexplainwhy Eichenetal.couldnotfindaconservativepainreductioneffect incompressionalonecomparedtobaseline[9].TheVAS/NPS reduction for lumbar nucleoplasty was demonstratedtobe superiortoconservativetherapywithinthefirst3months[9]. TheresultsofthisinvestigationalsoshowasignificantVAS superiorityat12months.

5.

Conclusion

LumbarPDDisaminimallyinvasivesafeprocedure,beingable toincreasefunctionalmobilityandreducelegpaininalong term follow-up in patients with symptomatic contained lumbar discherniations.Itappearstobemosteffectivefor younger patients with relatively short duration of pain symptoms.

Conflict

of

interest

Nonedeclared. Table 5 – Change s in quality o f life in the cons ervatively treated a n d PPD groups a mon g the four time poi nts of obs ervation. Abbre viations Base line 1 m o nth follow-up 3 m onths follow-up 12 months follow-up Tim e effect Tim e  grou p effect Con servative PDD Conse rvativ e PDD C onserv ative PDD Conse rvativ e PDD FP hp 2 FP hp 2 Mea n (SD ) Mea n (SD ) Mean (SD) Mea n (SD) Mea n (SD) Mea n (SD ) Mea n (SD) Me an (SD) PF 30.30 (23.30) 31.79 (31.16) 30.72 (32.48) 38.40 (20.41) 32.20 (31.19) 44.32 (36.05) 33.74 (30.73) 50.33 (31.86) 7.59 0.00 0.042 3.51 0.01 0.020 RP 40.02 (37.09) 39.22 (37.40) 46.77 (28.74) 47.57 (29.92) 49.01 (25.49) 50.28 (27.76) 50.45 (26.15) 50.72 (28.04) 14.44 0.00 0.08 0.115 0.95 0.001 BP 43.90 (30.61) 48.69 (22.91) 47.27 (27.29) 49.64 (23.64) 48.79 (72.68) 52.68 (23.25) 49.55 (27.46) 63.40 (23.68) 13.64 0.00 0.072 0.624 0.60 0.004 GH 32.57 (29.85) 38.48 (29.07) 34.33 (27.97) 45.82 (23.23) 34.70 (29.06) 47.43 (24.17) 36.02 (29.05) 59.26 (25.14) 7.84 0.00 0.043 2.38 0.04 0.013 VT 43.52 (20.42) 46.60 (20.01) 45.60 (23.09) 49.90 (21.19) 47.66 (22.88) 51.37 (20.97) 49.11 (21.69) 52.29 (21.24) 10.46 0.00 0.06 0.14 0.93 0.001 SF 45.80 (17.22) 49.95 (15.13) 46.54 (17.06) 51.55 (16.12) 46.69 (19.61) 53.11 (18.97) 46.69 (19.13) 53.34 (19.14) 2.25 0.08 0.013 0.817 0.49 0.005 RE 43.90 (30.61) 48.69 (22.91) 47.27 (27.29) 59.64 (23.64) 48.79 (26.95) 52.68 (23.25) 49.55 (27.46) 53.40 (23.68) 13.64 0.00 0.072 0.624 0.60 0.004 MH 33.22 (22.44) 35.11 (22.75) 33.52 (26.04) 39.10 (26.73) 35.53 (20.09) 41.54 (19.45) 38.23 (27.47) 47.83 (21.81) 16.32 0.00 0.085 2.81 0.039 0.016 PCS 39.05 (28.90) 39.76 (27.11) 41.97 (30.11) 44.47 (26.39) 44.96 (28.63) 53.40 (21.55) 45.11 (28.53) 55.38 (20.77) 16.63 0.00 0.087 3.36 0.019 0.019 MCS 35.23 (23.45) 38.66 (16.15) 37.16 (26.06) 41.68 (21.46) 38.98 (26.81) 44.99 (24.75) 39.43 (27.49) 45.80 (25.43) 13.144 0.00 0.070 0.904 0.439 0.0 05 Abbreviations : BP, bodily pain; CLBP, chronic low back pain; GH, general health perception; MCS, mental component summary; MH, mental health; PCS, physical compon ent summary; PF, physical functioning; RE, role limitations due to emotional problems; RP, role limitations due to physical health; SF, social functioning; VT, vitality.

Acknowledgement

and

financial

support

The study was funded by Qazvin University of Medical Sciences. The sponsor of this study had no role in study design,datacollection,dataanalysis,datainterpretation,or writingofthereport.Allauthorshadfullaccesstothedatain thestudyandthecorrespondingauthorhadfinal responsibili-tytosubmitforpublication.

Ethics

Thework described inthis article has been carriedout in accordance with The Code of Ethics of the World Medical Association(DeclarationofHelsinki)forexperiments involv-inghumans;UniformRequirementsformanuscripts submit-tedtoBiomedicaljournals.

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[1] PicavetHS,HazesJM.Prevalenceofselfreported

musculoskeletaldiseasesishigh.AnnRheumDis

2003;62:644–50.

[2] HestbaekL,Leboeuf-YdeC,MannicheC.Lowbackpain:

whatisthelong-termcourse?Areviewofstudiesofgeneral

patientpopulations. EurSpineJ2003;12:149–65.

[3] AnderssonGB,BrownMD,DvorakJ,HerzogRJ,KambinP,

MalterA,etal.Consensussummaryofthediagnosisand

treatmentoflumbardischerniation.Spine(PhilaPa1976)

1996;21:75S–8S.

[4] KelseyJL,White3rdAA.Epidemiologyandimpactof

low-backpain.Spine(PhilaPa1976)1980;5:133–42.

[5] PraemerA,FurnerS,RiceDP.Musculoskeletalconditionsin

theUnitedStates.Rosemont,IL:AmericanAcademyof

OrthopaedicSurgeons;1999.

[6] ManchikantiL,FalcoFJ,PampatiV,CashKA,BenyaminRM,

HirschJA.Costutilityanalysisofcaudalepiduralinjections

inthetreatmentoflumbardischerniation,axialor

discogeniclowbackpain,centralspinalstenosis,andpost

lumbarsurgerysyndrome.PainPhys2013;16:E129–43.

[7] PeulWC,vanHouwelingenHC,vandenHoutWB,BrandR,

EekhofJA,TansJT,etal.,Leiden-TheHagueSpine

InterventionPrognosticStudyG.Surgeryversusprolonged

conservativetreatmentforsciatica.NEnglJMed

2007;356:2245–56.

[8] WelchWC,GersztenPC.Alternativestrategiesforlumbar

discectomy:intradiscalelectrothermyandnucleoplasty.

NeurosurgFocus2002;13:E7.

[9] EichenPM,AchillesN,KonigV,MosgesR,HellmichM,

HimpeB,etal.Nucleoplasty,aminimallyinvasive

procedurefordiscdecompression:asystematicreviewand

meta-analysisofpublishedclinicalstudies.PainPhys

2014;17:E149–73.

[10] ManchikantiL,FalcoFJ,BenyaminRM,CarawayDL,Deer

TR,SinghV,etal.Anupdateofthesystematicassessment

ofmechanicallumbardiscdecompressionwith

nucleoplasty.PainPhys2013;16:SE25–54.

[11] GergesFJ,LipsitzSR,NedeljkovicSS.Asystematicreview

ontheeffectivenessofthenucleoplastyprocedurefor

discogenicpain.PainPhys2010;13:117–32.

[12] ManchikantiL,DerbyR,BenyaminRM,HelmS,HirschJA.A

systematicreviewofmechanicallumbardisc

decompressionwithnucleoplasty.PainPhys2009;12:

561–72.

[13] GersztenPC,SmuckM,RathmellJP,SimopoulosTT,Bhagia

SM,MocekCK,etal.Plasmadiscdecompressioncompared

withfluoroscopy-guidedtransforaminalepiduralsteroid

injectionsforsymptomaticcontainedlumbardisc

herniation:aprospective,randomized,controlledtrial.J

NeurosurgSpine2010;12:357–71.

[14] GibsonJN,WaddellG.Surgicalinterventionsforlumbar

discprolapse.CochraneDatabaseSystRev2007;CD001350.

[15] SathyakumarV,RadaidehM.Standardizingnomenclature

andclassificationoflumbardiscpathologyamongspine

practitioners.AmJRoentgenol2012;198.

[16] MousaviSJ,ParnianpourM,MehdianH,MontazeriA,

MobiniB.TheOswestryDisabilityIndex,theRoland-Morris

DisabilityQuestionnaire,andtheQuebecBackPain

DisabilityScale:translationandvalidationstudiesofthe

Iranianversions.Spine(PhilaPa1976)2006;31:E454–9.

[17] PakpourAH,SaffariM,YekaninejadMS,PanahiD,Harrison

AP,MolstedS.Health-relatedqualityoflifeinasampleof

Iranianpatientsonhemodialysis.IranJKidneyDis

2010;4:50–9.

[18] AdelmaneshF,ArvantajA,RashkiH,KetabchiS,

MontazeriA,RaissiG.Resultsfromthetranslationand

adaptationoftheIranianShort-FormMcGillPain

Questionnaire(I-SF-MPQ):preliminaryevidenceofits

reliability,constructvalidityandsensitivityinanIranian

painpopulation.SportsMedArthroscRehabilTherTechnol

2011;3:27.

[19] LemckeJ,Al-ZainF,MutzeS,MeierU.Minimallyinvasive

spinalsurgeryusingnucleoplastyandtheDekompressor

tool:acomparisonoftwomethodsinaoneyearfollow-up.

MinimInvasiveNeurosurg2010;53:236–42.

[20] KaramanH,TufekA,OlmezKavakG,YildirimZB,TemelV,

CelikF,etal.Effectivenessofnucleoplastyappliedfor

chronicradicularpain.MedSciMonit2011;17:CR461–6.

[21] KonigV,EichenPM,AchillesN,MosgesR.Asystematic

reviewofRCTswithnucleoplasty–anupdate.PainPhys

2013;16:E45–6.

[22] BhagiaSM,SlipmanCW,NirschlM,IsaacZ,El-AbdO,

SharpsLS,etal.Sideeffectsandcomplicationsafter

percutaneousdiscdecompressionusingcoblation

technology.AmJPhysMedRehabil2006;85:6–13.

[23] SmuckM,BennyB,HanA,LevinJ.Epiduralfibrosis

followingpercutaneousdiscdecompressionwithcoblation

technology.PainPhys2007;10:691–6.

[24] BokovA,SkorodumovA,IsrelovA,StupakY,KukarinA.

Differentialtreatmentofnerverootcompressionpain

causedbylumbardischerniationapplyingnucleoplasty.

PainPhys2010;13:469–80.

[25] PintoRZ,MaherCG,FerreiraML,HancockM,OliveiraVC,

McLachlanAJ,etal.Epiduralcorticosteroidinjectionsinthe

managementofsciatica:asystematicreviewand