doi: 10.2522/ptj.20120256Originally published online February 21, 2013

Published online February 21, 2013PHYS THER. and Leonardo Oliveira Pena CostaLucíola da Cunha Menezes Costa, Lívia Leticia Rissato Ronaldo Fernando de Oliveira, Richard Eloin Liebano,Controlled Trial

RandomizedPatients With Chronic Low Back Pain: A Region-Specific Spinal Manipulative Therapy in

−Immediate Effects of Region-Specific and Non

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Immediate Effects of Region-Specificand Non–Region-Specific SpinalManipulative Therapy in Patients WithChronic Low Back Pain: A RandomizedControlled TrialRonaldo Fernando de Oliveira, Richard Eloin Liebano,Lucıola da Cunha Menezes Costa, Lıvia Leticia Rissato,Leonardo Oliveira Pena Costa

Background. Manual therapists typically advocate the need for a detailed clinicalexamination to decide which vertebral level should be manipulated in patients withlow back pain. However, it is unclear whether spinal manipulation needs to bespecific to a vertebral level.

Objective. The purpose of this study was to analyze the immediate effects of asingle, region-specific spinal manipulation defined during the clinical examinationversus a single non–region-specific spinal manipulation (applied on an upper thoracicvertebra) in patients with chronic nonspecific low back pain for the outcomemeasures of pain intensity and pressure pain threshold at the time of the assessment.

Design. This was a 2-arm, prospectively registered, randomized controlled trialwith a blinded assessor.

Setting. The study was conducted in an outpatient physical therapy clinic in Brazil.

Patients. The study participants were 148 patients with chronic nonspecific lowback pain (with pain duration of at least 12 weeks).

Randomization. The randomization schedule was generated by an independentstatistician and was concealed by using consecutively numbered, sealed, opaqueenvelopes.

Interventions. A single high-velocity manipulation was administered to theupper thoracic region of the participants allocated to the non–region-specific manip-ulation group and to the painful lumbar levels of the participants allocated to theregion-specific manipulation group.

Measurements. Pain intensity was measured by a 0 to 10 numeric pain ratingscale. Pressure pain threshold was measured using a pressure algometer.

Limitations. It was not possible to blind the therapist and participants.

Results. A total of 148 patients participated in the study (74 in each group). Therewas no loss to follow-up. Both groups improved in terms of immediate decrease ofpain intensity; however, no between-group differences were observed. The between-group difference for pain intensity and pressure pain threshold were 0.50 points(95% confidence interval��0.10 to 1.10) and �1.78 points (95% confidence inter-val��6.40 to 2.82), respectively. No adverse reactions were observed.

Conclusion. The immediate changes in pain intensity and pressure pain thresholdafter a single high-velocity manipulation do not differ by region-specific versusnon–region-specific manipulation techniques in patients with chronic low back pain.

R.F. de Oliveira, Master’s and Doc-toral Programs in Physical Ther-apy, Universidade Cidade de SaoPaulo, Sao Paulo, Brazil.

R.E. Liebano, Master’s and Doc-toral Programs in Physical Ther-apy, Universidade Cidade de SaoPaulo.

L.C.M. Costa, Master’s and Doc-toral Programs in Physical Ther-apy, Universidade Cidade de SaoPaulo.

L.L. Rissato, Physical TherapyDepartment, UBS Santo AntonioAracangua, Sao Paulo, Brazil.

L.O.P. Costa, PT, PhD, Master’sand Doctoral Programs in PhysicalTherapy, Universidade Cidade deSao Paulo, Rua Cesario Galeno475, CEP 03071-000, Tatuape,Sao Paulo, Brazil, and Musculosk-eletal Division, The George Insti-tute for Global Health, Level 7,341 George St, Sydney, NewSouth Wales, 2050 Australia.Address all correspondence to DrCosta at: lcos3060@gmail.com.

[de Oliveira RF, Liebano RF, CostaLCM, et al. Immediate effects ofregion-specific and non–region-specific spinal manipulative ther-apy in patients with chronic lowback pain: a randomized con-trolled trial. Phys Ther. 2013;93:xxx–xxx.]

© 2013 American Physical TherapyAssociation

Published Ahead of Print:February 21, 2013

Accepted: February 14, 2013Submitted: June 14, 2012

Research Report

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Low back pain is a significanthealth condition worldwide1,2

due to its impact on work dis-ability, absenteeism, and costs.3 Asystematic review on the global prev-alence of low back pain identifiedthat the 1-month prevalence wasestimated to be 23.2% (standarderror of the measurement�2.9%)and is higher in women and inpatients aged between 40 and 80years.4 This high prevalence is asso-ciated with high treatment costs.3

The most recent systematic reviewon the prognosis of this conditionindicates that, although patientswith acute low back pain (with apain duration of at least 6 weeks)recover rapidly, only a third ofpatients with chronic low back pain(with a pain duration of at least 12weeks) recover within 12 monthsafter the onset of symptoms.5

In an attempt to reduce the greatimpact associated with chronic lowback pain, a large number of treat-ments have been recommended bythe European guidelines for the man-agement of chronic nonspecific lowback pain.6 These guidelines endorsethe use of spinal manipulative ther-apy (SMT) in patients with chroniclow back pain given that SMT ispotentially effective7 and cost-effective when used alone or in com-bination with other techniques com-pared with general practitioner care,exercises, or general physical ther-apy.8 These conclusions are verysimilar to the low back pain guide-lines recently published by Delittoet al.9

Although SMT is considered a poten-tially effective intervention forpatients with low back pain,6,9 differ-ent theories and mechanisms ofaction for SMT are still under discus-sion.10–13 Many manual therapists,osteopaths, and chiropractors arestill heavily orientated by a biome-chanical mechanism where mechan-ical forces applied to specific verte-

bral regions may alter segmentalbiomechanics by releasing trappedmeniscoid lesions, releasing adhe-sions, or reducing distortions of theannulus fibrosus.13 This biomechani-cal mechanism of action wouldallow the vertebral segments tomove in a greater range of motionand would reduce the mechanicalstress on paraspinal muscles, thusreducing pain and discomfort. How-ever, the mechanisms underlying theeffects of SMT seem much more com-plex than a simple biomechanical-oriented model and are more likelyto be better explained by a combina-tion of biomechanical and nonbio-mechanical effects.10–15

A large bulk of evidence on nonbio-mechanical effects of SMT in peoplewho are healthy and those withsymptoms of low back pain hasbeen published over the lastdecade.12,13,16–18 It is now knownthat spinal manipulation increasespain threshold and pain tolerance,evokes paraspinal muscle reflexes,alters motoneuron excitability andthermal pain sensitivity, and reducestemporal summation in both individ-uals who are healthy and those with-out symptoms of low backpain.12,13,16–18 A recent systematicreview11 investigating changes inpain sensitivity following spinalmanipulation identified significantchanges in pain sensitivity in bothlocal and remote anatomic sites.These findings suggest that SMT canbe beneficial beyond the effects onthe local site of the manipulation interms of pain sensitivity. However,most of the individual studies fromthis review were performed in par-ticipants who were healthy16,17 orrecruited a small sample of patientswith low back pain (n�36).18 There-fore, larger studies with patientswith low back are needed to eluci-date the effects of region-specific ornon–region-specific effects of SMT inthis patient population.

Chiradejnant et al15 investigated theefficacy of “therapist-selected” ver-sus “randomly selected” mobiliza-tion techniques in 140 patients withchronic low back pain. The authorsconcluded that lumbar mobilizationhad an immediate effect in terms ofpain intensity, but the region ofmobilization was considered to beunimportant. The results of this ran-domized controlled trial reinforcethe idea that the treatment effectsare more likely to be mediated by thecentral nervous system rather thanjust being biomechanically orien-tated. Our study aimed to extend thefindings of the study by Chiradejnantet al by testing 2 new factors: (1) thetype of SMT (high-velocity manipula-tion) and (2) measuring not onlypain intensity but also pressure painthreshold (PPT). The results fromour study could lead to a betterunderstanding of nonbiomechanicaleffects of this popular interventionin patients with chronic low backpain.

Therefore, the objectives of thisstudy were: (1) to analyze the imme-diate effects of a single manipulationat a defined, region-specific vertebrallevel of the lower back during a clin-ical examination versus a non–region-specific vertebral level (highthoracic vertebrae) in patients withchronic nonspecific low back pain interms of pain intensity and (2) tocompare the effects of these 2 inter-ventions on PPT.

MethodStudy TypeA 2-arm, randomized controlled trialwith a blinded assessor wasconducted.

Inclusion and Exclusion CriteriaWe considered eligible for the studypatients who were seeking physicaltherapy treatment for chronic non-specific low back pain (ie, lastingmore than 12 weeks)6,19 and thoserecruited from the community with

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symptoms of chronic low back painwho were aged from 18 to 80 yearsof both sexes and with a minimumpain intensity score of 3 on an11-point numeric pain rating scale(ranging from 0 to 10 points)20,21 atthe time of the assessment. Theexclusion criteria were: contraindi-cations to the treatment (eg, spinalcanal stenosis, spinal fracture, acuterheumatic diseases, hemorrhagic dis-eases, active tuberculosis, recentdeep vein thrombosis),22 pregnancy,nerve root compromise, and previ-ous spinal surgery.

Source of PatientsThe study was conducted at thePhysical Therapy Department of thecity of Santo Antonio de Aracangua,Brazil, between September 2011 andJanuary 2012.

ProcedureAll participants were informed aboutthe study objectives and proceduresand, if they agreed to participate,signed an informed consent form.Following that, they were assessedby a therapist who was blinded tothe allocation to treatment groups.The therapist also collected demo-graphic data and assessed pain inten-sity (measured by the numeric painrating scale),20,21 pressure painthreshold (measured with a pressurealgometer) at lumbar levels L3 andL5 bilaterally and at the middle of thetibialis anterior muscle bilaterally,and disability associated with lowback pain (measured by the Roland-Morris Disability Questionnaire).23,24

Due to the nature of the interven-tions, it was not possible to blind thetherapist and the study participants.

Random Allocation, PhysicalAssessments, and InterventionsAfter the initial assessment, the par-ticipants were taken to the treatmentroom and the therapist conductedthe anamnesis and the clinical exam-ination (details below). Based on theclinical examination, the therapist

determined the vertebral level in thelumbar area to be manipulated.Next, the therapist opened the ran-domization envelope informingwhether the vertebral level shouldbe manipulated “according to thephysical examination” or “at thelevel of the upper thoracic verte-brae.” A researcher not involved inthe data collection generated therandomization codes with a 1:1 allo-cation ratio using Excel for Windowssoftware (Microsoft Corporation,Redmond, Washington). The ran-domization codes were placed inconsecutively numbered, sealed,opaque envelopes, thus ensuring theconcealed allocation of participantsto groups.25

Assessment and PhysicalExaminationThe therapist who took part in thestudy had 41⁄2 years of clinical expe-rience in treating patients with lowback pain and was specialized inmanual therapy, working mainlywith SMT techniques at the healthcenter of the city where the studywas conducted. During the physicalexamination, the therapist askedeach participant to identify the pain-ful vertebral level, which was con-firmed upon inspection and palpa-tion. The therapist then asked theparticipant to perform all of thetrunk movements (flexion, exten-

sion, side bending, and rotation) toobserve the presence of pain andrestricted movement, as well as anta-lgic posture, followed by palpationof bone and muscle tissues. The diag-nostic palpation test in the trans-verse plane, also known as theMitchell test, was used to verify ver-tebral positioning and mobility.22

InterventionsIf the participant had been allocatedto the non–region-specific manipula-tion group, he or she received a sin-gle, “global” high-velocity manipula-tion (not defined by the clinicalexamination) at the upper thoracicregion between T1 and T5 levels inthe dorsal decubitus position(Fig. 1A). If allocated to the region-specific manipulation group, the par-ticipant was manipulated betweenL2 and L5 according to the thera-pist’s clinical examination (Fig. 1B).Then, the participant was reassessedfor the outcome measures of painintensity and PPT by a therapist whowas masked with regard to the treat-ment allocation. The participant alsowas interviewed regarding any pos-sible adverse effects of the treat-ment. These possible adverse effectswere assessed by 2 open-ended ques-tions: (1) “Did your symptoms getworse after this treatment?” and (2)“Are you feeling any different symp-tom after this treatment?”

Figure 1.Non–region-specific manipulation (A) and region-specific manipulation (B).

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BlindingThe assessor was blinded to the treat-ment allocation and performed anassessment before and after the inter-vention. To test the blinding, theassessor, after the assessment of theclinical outcomes, wrote on thepatient’s chart which type of manip-ulation he thought the patient hadreceived. These codes were latercompared with the randomizationcodes.

Measurement Instruments andOutcomesTo assess the participants, a chartwas used containing the following:start date of treatment and inclusionand exclusion criteria. The partici-pants provided demographic datasuch as age, body mass, marital sta-tus, educational level, and contactdetails. They also provided datarelated to disability associated withlow back pain, pain intensity, andPPT. The description of each mea-surement instrument is given below.

Numeric pain rating scale. An11-point numeric pain ratingscale20,21 was used to assess painintensity (primary outcome mea-sure), with 0 representing “no pain”and 10 representing the “worst pos-sible pain” at the time of the assess-ment. Pain intensity was measuredbefore and after treatment.

Pressure algometer. The algome-ter is a device that measures pressureor applied force on any part of thebody. The PPT (secondary outcome)was measured by the blinded asses-sor with a pressure algometer (Kra-tos model DDK, Kratos Ltd, SaoPaulo, Brazil) before and after thetreatment. The assessor asked theparticipant to lie down on the tableand marked 2 points bilaterally: thefirst point was located 5 cm laterallyfrom the L3 spinous process, and thesecond point was located 5 cm later-ally from the L5 spinous process.26 Apoint also was marked bilaterally on

the middle third of the tibialis ante-rior muscle.27

During PPT measurement, the asses-sor positioned the algometer’s circu-lar probe (1 cm2 in area) perpendic-ularly to the skin and pressed at arate of approximately 5 N/s. The par-ticipants were asked to say “stop”when the sensation of pressure ordiscomfort became a clear sensationof pain. Three measurements (innewtons) were collected for eacharea at 30-second intervals. Themean of 3 measurements was usedfor the data analysis. If the partici-pant did not report pain to a forceequivalent to 100 N, the test wasinterrupted, and this value was con-sidered the PPT.27 For each partici-pant, the assessor performed 2 dem-onstrations of the procedure on theextensor muscles of the dominantforearm to ensure that the partici-pant understood the test. If the par-ticipant had any questions, a thirddemonstration was performed. Forthe pain threshold data analysis, themean values for the lumbar regionand the tibialis anterior muscle wereused.

The assessor of the present studyperformed a preliminary intra-examiner reliability study for the PPTmeasurement of the pointsdescribed above. Ten participantswith chronic low back pain wererecruited and assessed on 2 occa-sions with a 48-hour interval. Reli-ability was considered excellent,with intraclass correlation coeffi-cients (type 3,3) of .95 (95% confi-dence interval [CI]�.82 to .99) and.92 (95% CI�.69 to .98) for the tib-ialis anterior and lumbar muscles,respectively.

Roland-Morris Disability Ques-tionnaire. The Roland-Morris Dis-ability Questionnaire has been trans-lated and cross-culturally adapted tothe Brazilian population,23 and itmeasures disability levels associated

with low back pain. The question-naire contains 24 items related todaily activities that patients may havedifficulty performing due to lowback pain. The more items checked,the greater the disability.28 Thisquestionnaire was applied only inthe pretreatment assessment todescribe the participants’ level of dis-ability at baseline.

Data AnalysisThe sample size was calculated a pri-ori to detect a difference of 1.0 pointfor pain intensity as measured withthe numeric pain rating scale (withan estimated standard deviation of1.84 points). A statistical power of80%, alpha of .05, and sample loss tofollow-up of 15% were considered;therefore, 74 patients were neededper group (148 total).

Data normality was tested throughvisual inspection of histograms, andall of the outcomes had normal dis-tribution. Participant descriptionwas performed through descriptivestatistical tests. Assessor blindingwas tested with the chi-square test.Within-group differences and theirrespective 95% CI values were calcu-lated using paired-samples t tests.The between-group differences andtheir respective 95% CI values werecalculated through mixed linearmodels using the interaction termsof time versus group. These interac-tion terms are equivalent to thebetween-group differences (ie, theeffect of the intervention). Pearsoncorrelation coefficients (r) were cal-culated using the entire sample toinvestigate whether changes in painintensity were correlated withchanges in PPT. We used the SPSSversion 18 software (SPSS Inc, Chi-cago, Illinois) for the analyses, whichwere performed on an intention-to-treat basis.

ResultsParticipant recruitment and inclu-sion were conducted between Sep-

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tember 2011 and January 2012. Par-ticipant characteristics at baselineare described in Table 1. The partic-ipants were mainly female with amean age of 46 years and with long-term symptoms of low back pain(mean duration of symptoms ofmore than 100 months) and moder-ate levels of pain intensity and dis-ability. The demographic character-istics and the outcomes were similarat baseline. A total of 150 patientswere considered for inclusion, andonly 2 were excluded due to lowlevels of pain intensity (lower than 3points on the numeric pain ratingscale). All participants were fol-lowed up. A detailed flow diagram ofthe process of recruitment, exclu-sion, assessment, and intervention ispresented in Figure 2.

Both groups improved in terms ofpain intensity; the within-group dif-ference was 1.91 points (95%CI�1.51 to 2.30) in the region-specific manipulation group and1.41 points (95% CI�0.95 to 1.87) inthe non–region-specific group. How-ever no between-group statisticallysignificant differences were detected(Tab. 2). The between-group differ-ence for pain intensity was 0.50points (95% CI��0.10 to 1.10;P�.10).

No changes in PPT were observed inthe region-specific manipulationgroup at lumbar levels (within-groupdifference��1.86 N, 95% CI��5.34 to 1.62) or at tibialis anteriormuscle level (within-group differ-ence��2.23 N, 95% CI��4.77 to0.30). The non–region-specificmanipulation group increased PPTlocally (ie, at lumbar levels) (within-group difference��3.65 N, 95%CI��6.73 to �0.57) but notremotely (ie, tibialis anterior musclelevel) (within-group difference��1.04 N, 95% CI��3.90 to 1.82).Similar to pain intensity, there wereno statistically significant between-group differences for PPT at lumbar

levels (between-group differ-ence��1.78 N, 95% CI��6.40 to2.82, P�.44) or at tibialis anteriormuscle level (between-group differ-ence�1.19 N, 95% CI��2.60 to4.98, P�.53). No adverse effectswere observed in any of theparticipants.

Assessor blinding was confirmed asthe assessor only guessed the correctlocation of manipulation in 48.1% ofthe cases (P�.92). We observed a

positive and moderate correlationbetween changes in PPT at lumbarlevels and changes in PPT at tibialisanterior muscle level (r�.56,P�.01). We also observed a negativeand small correlation betweenchanges in pain and changes in PPTat lumbar levels (r��.25, P�.003)and at tibialis anterior muscle level(r��.32, P�.01).

Table 1.Demographic Characteristics of the Participants at Baselinea

Variable

Non–Region-Specific

ManipulationGroup

Region-SpecificManipulation

Group

Age (y) 45.95 (12.30) 46.32 (10.22)

Height (m) 1.64 (0.10) 1.63 (0.68)

Body mass (kg) 74.84 (13.93) 75.45 (16.42)

Duration of symptoms (mo) 103.82 (112.07) 112.47 (125.55)

Sex

Female 50 (67.6) 59 (79.7)

Male 24 (32.4) 15 (20.3)

Marital status

Single 10 (13.5) 6 (8.1)

Married 54 (73) 56 (75.7)

Divorced 4 (5.4) 9 (12.2)

Widowed 6 (8.1) 3 (4.1)

Education status

Elementary degree (incomplete) 1 (1.4) 2 (2.7)

Elementary degree (complete) 32 (43.2) 36 (48.6)

High school 22 (29.7) 23 (31.1)

Graduate 18 (24.3) 12 (16.2)

Postgraduate 1 (1.4) 1 (1.4)

Smoking status

Yes 12 (16.2) 10 (13.5)

No 62 (83.8) 64 (86.5)

Disability (RMDQ, 0–24) 9.36 (5.68) 11.26 (5.69)

Outcome measures

Pain intensity (NPRS, 0–10) 5.95 (2.20) 6.07 (2.12)

Pressure pain threshold (N)

Lumbar spine levels 48.90 (23.99) 49.63 (19.46)

Tibialis anterior muscle level 60.21 (22.36) 61.11 (19.55)

a Categorical variables are expressed as number (%); continuous variables are expressed as mean (SD).RMDQ�Roland-Morris Disability Questionnaire, NPRS�numeric pain rating scale).

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DiscussionThis study aimed to test the immedi-ate effects of a single, high-velocitymanipulation performed at a region-specific vertebral level defined dur-ing the clinical examination versus ata non–region-specific vertebral level(upper thoracic vertebrae) inpatients with chronic nonspecificlow back pain for the outcome mea-sures of pain intensity and PPT. Nobetween-group differences wereobserved for both pain intensity andPPT outcomes.

There is high-quality methodologicalevidence to support the use of SMT

in the treatment of patients withchronic low back pain. This inter-vention also is recommended by clin-ical practice guidelines for the treat-ment of low back pain6,29 and othermusculoskeletal disorders.30 In ourstudy, both groups had a reductionof nearly 30% from baseline in painintensity after treatment. The resultsof the present study question theneed for the detailed assessmentadvocated in the manual therapyfield,22 when the goal is immediatepain relief, given that non–region-specific manipulation was just aseffective as region-specific manipula-tion. Therefore, our results refute

that a biomechanical approach wouldexplain the reductions in pain inten-sity that were experienced by thestudy participants. Nevertheless,studies with longer follow-up timesand with a placebo or nontreatmentgroup are needed determine the clin-ical relevance of these findings.

SMT and Pain IntensityThe observed reductions in painintensity observed in this study aremore likely to be explained by spi-nal, supraspinal, or even nonspecificmechanisms that can mediate pain,as suggested by a theoretical modeldeveloped by Bialosky et al.10 This

Figure 2.Trial flow diagram.

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model suggests that a mechanicalforce from a spinal manipulation ini-tiate a cascade of neurophysiologicalresponses from both the peripheraland central nervous systems thatmight explain improvements in clin-ical outcomes, such as pain intensity.Nonspecific effects, such as expecta-tion and psychosocial factors, alsomight explain the pain reductionobserved in both groups.10,12 Newstudies are needed to better investi-gate these factors.

Finally, the reductions in painobserved in both groups also may bedue to the placebo effect or toregression to the mean. The onlyway to control for these confound-ing factors would be to include aplacebo manipulation group, whichis a controversial topic in the litera-ture,31 given that the leading lowback pain researchers have not beenable to establish the ideal placebo forvertebral manipulation. However,we could have controlled for regres-sion to the mean by including a non-treatment control group, which canbe considered one of the limitationsof our study.

SMT and PPTWe also did not identify a between-group difference in PPT. Participantsallocated the region-specific groupdid not increase their PPT. Partici-pants allocated to the non–region-specific group increased PPT locally(ie, at lumbar levels) but notremotely (ie, at tibialis anterior mus-cle level). Our findings are very sim-ilar to those of a recent meta-analysisthat investigated changes in pain sen-sitivity following spinal manipula-tion.11 The included studies showedan increase in PTT only for patientswith neck pain after spinal manipu-lation or mobilization.32–34 However,the only study that included assess-ment of PPT in patients with chronicmechanical low back pain did notshowed PPT changes after spinalmanipulation or mobilization.35 In Ta

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conclusion, the summary effect esti-mate demonstrated a small favorable,but nonsignificant, effect of spinalmanipulation or mobilization onincreasing PPT in participants whowere symptomatic. This review11

also concluded that the effect of spi-nal manipulation on PPT was largestwhen measured at a remote anatom-ical region, which was not observedin our study. Our study can addimportant information about theeffects of SMT on PPT in patientswith chronic low back pain, as morethan a half of the studies included inthe systematic review11 recruitedonly people who were healthy. Asurprising finding observed in thepresent study was a statistical signif-icant difference for hypoalgesia inthe non–region-specific group atlumbar levels. However, the differ-ence observed was small (ie, lowerthan 4 N) and may have been due tochance or measurement error. It hasbeen suggested that a difference inPPT of at least 9.9 N would be nec-essary to represent a clinically rele-vant change.36

Strengths and Limitations of theStudyAll possible care was taken to ensurethat the present study had a low riskof bias by including adequate ran-domization procedures, concealedallocation, blinding of the assessor,similarity at baseline, sample size cal-culation, and intention-to-treat analy-sis in the methods. Blinding of theassessor was confirmed by the factthat the assessor was not able toguess which patients were allocatedto the region-specific and non–region-specific manipulation groups.In contrast, it was not possible toblind the therapist or the patientsdue to the nature of the interven-tions, which does not eliminate therisk of bias. Blinding of therapistsand patients is not feasible in trialswith active treatment interventions,such as exercise or manipulation, orethical (given requirements of infor-

mation sheet information). There-fore, lack of blinding of the therapistor patients could be interpreted as alimitation of the study. Other limita-tions of this study include recruitinga mixed population of patients whowere seeking physical therapy fortheir low back pain and patientsfrom the community, the lack of aplacebo or nontreatment group, anda selection of patients with long-standing pain. These factors mayhave limited the response of theseinterventions.

Suggestions for Future StudiesThe results of this study arerestricted to the immediate effects ofmanipulation (less than 24 hours);however, it is not known whetherthese effects are maintained over alonger period of time. Therefore,these results would have to be vali-dated for long-term treatment. Theeffects and mechanisms of action ofthese techniques could be analyzedin a sample of patients who weremore likely to respond to SMT asdetermined by a clinical predictionrule.37 Studies investigating nonspe-cific effects also are needed. Finally,it is important to note that the resultsof this study are generalizable only topatients with long-standing pain andmay not be similar in patients withacute or subacute low back pain.Similarly, our results are only gener-alizable for the immediate effects of asingle, high-velocity manipulation.As neuroplastic changes take time todevelop and the responses to spinalmanipulation are different betweenpatients with chronic and acute lowback pain, it is likely that studiesrecruiting patients with acute lowback pain and with longer follow-upperiods will provide different results.

ConclusionThis study showed that immediatechanges in pain intensity and PPTafter a single high-velocity manipula-tion do not differ by region-specificversus non–region-specific manipu-

lation techniques in patients withchronic low back pain.

All authors provided concept/idea/researchdesign. Mr de Oliveira, Professor Liebano, DrLucıola Costa, and Dr Leonardo Costa pro-vided writing and data analysis. Mr deOliveira and Ms Rissato provided data collec-tion and study participants. Mr de Oliveira,Ms Rissato, and Dr Leonardo Costa providedproject management. Dr Leonardo Costaprovided institutional liaisons. Mr deOliveira, Professor Liebano, Ms Rissato, andDr Leonardo Costa provided facilities/equip-ment and consultation (including review ofmanuscript before submission).

Ethics approval for this study was obtainedfrom the Research Ethics Committee of theUniversidade Cidade de Sao Paulo.

This trial was registered prior to the begin-ning of data collection with the BrazilianRegistry of Clinical Trials (RBR-7CB9yc).

DOI: 10.2522/ptj.20120256

References1 Volinn E. The epidemiology of low back

pain in the rest of the world: a review ofsurveys in low- and middle-income coun-tries. Spine. 1997;22:1747–1754.

2 van Tulder MW, Koes BW, Bouter LM. Acost-of-illness study of back pain in TheNetherlands. Pain. 1995;62:233–240.

3 Dagenais S, Caro J, Haldeman S. A system-atic review of low back pain cost of illnessstudies in the United States and interna-tionally. Spine J. 2008;8:8–20.

4 Hoy D, Bain C, Williams G, et al. A system-atic review of the global prevalence of lowback pain. Arthritis Rheum. 2012;64:2028–2037.

5 da C Menezes Costa L, Maher CG, Han-cock MJ, et al. The prognosis of acute andpersistent low-back pain: a meta-analysis.CMAJ. 2012;184:E613–E624.

6 Airaksinen O, Brox JI, Cedraschi C, et al;for the COST B13 Working Group onGuidelines for Low Back Pain. Chapter 4:European guidelines for the managementof chronic nonspecific low back pain. EurSpine J. 2006;15(suppl 2):S192–S300.

7 Rubinstein SM, van Middelkoop M, Assen-delft WJ, et al. Spinal manipulative therapyfor chronic low-back pain. CochraneDatabase Syst Rev. 2011;(2):CD008112.

8 Michaleff ZA, Lin CW, Maher CG, et al.Spinal manipulation epidemiology: sys-tematic review of cost effectiveness stud-ies. J Electromyogr Kinesiol. 2012;22:655–662.

9 Delitto A, George SZ, Van Dillen LR, et al.Low back pain. J Orthop Sports Phys Ther.2012;42:A1–A57.

Spinal Manipulative Therapy in Patients With CLBP

8 f Physical Therapy Volume 93 Number 6 June 2013 at Fisher Library on March 22, 2013http://ptjournal.apta.org/Downloaded from

10 Bialosky JE, Bishop MD, Price DD, et al.The mechanisms of manual therapy in thetreatment of musculoskeletal pain: a com-prehensive model. Man Ther. 2009;14:531–538.

11 Coronado RA, Gay CW, Bialosky JE, et al.Changes in pain sensitivity following spi-nal manipulation: a systematic review andmeta-analysis. J Electromyogr Kinesiol.2012;22:752–767.

12 Bialosky JE, Simon CB, Bishop MD, et al.Basis for spinal manipulative therapy: aphysical therapist perspective. J Electro-myogr Kinesiol. 2012;22:643–647.

13 Pickar JG. Neurophysiological effects ofspinal manipulation. Spine J. 2002;2:357–371.

14 Kent P, Mjosund HL, Petersen DH. Doestargeting manual therapy and/or exerciseimprove patient outcomes in nonspecificlow back pain? A systematic review. BMCMed. 2010;8:22.

15 Chiradejnant A, Maher CG, Latimer J, et al.Efficacy of “therapist-selected” versus“randomly selected” mobilisation tech-niques for the treatment of low back pain:a randomised controlled trial. Aust J Phys-iother. 2003;49:233–241.

16 Bishop MD, Beneciuk JM, George SZ.Immediate reduction in temporal sensorysummation after thoracic spinal manipula-tion. Spine J. 2011;11:440–446.

17 George SZ, Bishop MD, Bialosky JE, et al.Immediate effects of spinal manipulationon thermal pain sensitivity: an experimen-tal study. BMC Musculoskelet Disord.2006;7:68.

18 Bialosky JE, Bishop MD, Robinson ME,et al. Spinal manipulative therapy has animmediate effect on thermal pain sensitiv-ity in people with low back pain: a ran-domized controlled trial. Phys Ther. 2009;89:1292–1303.

19 Waddell G. The Back Pain Revolution.2nd ed. London, United Kingdom:Churchill Livingstone; 2004.

20 Childs JD, Piva SR, Fritz JM. Responsive-ness of the numeric pain rating scale inpatients with low back pain. Spine (PhilaPa 1976). 2005;30:1331–1334.

21 Williamson A, Hoggart B. Pain: a review ofthree commonly used pain rating scales.J Clin Nurs. 2005;14:798–804.

22 Kuchera ML. Applying osteopathic princi-ples to formulate treatment for patientswith chronic pain. J Am Osteopath Assoc.2007;107:ES28–ES38.

23 Costa LO, Maher CG, Latimer J, et al. Clini-metric testing of three self-report outcomemeasures for low back pain patients inBrazil: which one is the best? Spine. 2008;33:2459–2463.

24 Nusbaum L, Natour J, Ferraz MB, et al.Translation, adaptation and validation ofthe Roland-Morris questionnaire: BrazilRoland-Morris. Braz J Med Biol Res. 2001;34:203–210.

25 Herbert R Jamtvedt G, Mead J, Hagen KB.Practical Evidence-Based Physiotherapy.London, United Kingdom: Elsevier; 2005.

26 Meeus M, Roussel NA, Truijen S, et al.Reduced pressure pain thresholds inresponse to exercise in chronic fatiguesyndrome but not in chronic low backpain: an experimental study. J RehabilMed. 2010;42:884–890.

27 O’Neill S, Kjaer P, Graven-Nielsen T, et al.Low pressure pain thresholds are associ-ated with, but does not predispose for,low back pain. Eur Spine J. 2011;20:2120–2125.

28 Costa LO, Maher CG, Latimer J, et al. Psy-chometric characteristics of the Brazilian-Portuguese versions of the Functional Rat-ing Index and the Roland-Morris DisabilityQuestionnaire. Spine (Phila Pa 1976).2007;32:1902–1907.

29 American Osteopathic Association guide-lines for osteopathic manipulative treat-ment (OMT) for patients with low backpain. J Am Osteopath Assoc. 2010;110:653–666.

30 Posadzki P, Ernst E. Osteopathy for mus-culoskeletal pain patients: a systematicreview of randomized controlled trials.Clin Rheumatol. 2011;30:285–291.

31 Hancock MJ, Maher CG, Latimer J, et al.Selecting an appropriate placebo for a trialof spinal manipulative therapy. Aust JPhysiother. 2006;52:135–138.

32 de Camargo VM, Alburquerque-Sendin F,Berzin F, et al. Immediate effects on elec-tromyographic activity and pressure painthresholds after a cervical manipulation inmechanical neck pain: a randomized con-trolled trial. J Manipulative Physiol Ther.2011;34:211–220.

33 Mansilla-Ferragut P, Fernandez-de-LasPenas C, Alburquerque-Sendin F, et al.Immediate effects of atlanto-occipital jointmanipulation on active mouth openingand pressure pain sensitivity in womenwith mechanical neck pain. J Manipula-tive Physiol Ther. 2009;32:101–106.

34 Vernon HT, Aker P, Burns S, et al. Pressurepain threshold evaluation of the effect ofspinal manipulation in the treatment ofchronic neck pain: a pilot study. J Manip-ulative Physiol Ther. 1990;13:13–16.

35 Cote P, Mior SA, Vernon H. The short-termeffect of a spinal manipulation on pain/pressure threshold in patients withchronic mechanical low back pain.J Manipulative Physiol Ther. 1994;17:364–368.

36 Chesterton LS, Foster NE, Wright CC, et al.Effects of TENS frequency, intensity andstimulation site parameter manipulationon pressure pain thresholds in healthyhuman subjects. Pain. 2003;106:73–80.

37 Childs JD, Fritz JM, Flynn TW, et al. A clin-ical prediction rule to identify patientswith low back pain most likely to benefitfrom spinal manipulation: a validationstudy. Ann Intern Med. 2004;141:920–928.

Spinal Manipulative Therapy in Patients With CLBP

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doi: 10.2522/ptj.20120256Originally published online February 21, 2013

Published online February 21, 2013PHYS THER. and Leonardo Oliveira Pena CostaLucíola da Cunha Menezes Costa, Lívia Leticia Rissato Ronaldo Fernando de Oliveira, Richard Eloin Liebano,Controlled Trial

RandomizedPatients With Chronic Low Back Pain: A Region-Specific Spinal Manipulative Therapy in

−Immediate Effects of Region-Specific and Non

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