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w w w . e l s e v i e r . c o m / l o c a t e / p a i n

Acupuncture in patients with acute low back pain: A multicentre randomisedcontrolled clinical trial

Jorge Vas a,⇑, José Manuel Aranda b, Manuela Modesto a, Nicolás Benítez-Parejo c,d, Antonia Herrera e,Dulce María Martínez-Barquín f, Inmaculada Aguilar a, Max Sánchez-Araujo g,h, Francisco Rivas-Ruiz c,d

a Public Health System, Servicio Andaluz de Salud, Pain Treatment Unit, Doña Mercedes Primary Health Care Centre, Dos Hermanas, Spainb Public Health System, Servicio Andaluz de Salud, San Andres Torcal Primary Health Care Centre, Málaga, Spainc Support Research Unit, Costa del Sol Hospital, Marbella, Spaind CIBER de Epidemiología y Salud Pública (CIBERESP), Spaine Public Health System, Servicio Andaluz de Salud, Unidad de Gestión Clinica de Rehabilitación, Hospital Regional Universitario Carlos Haya, Málaga, Spainf Public Health System, Servicio Andaluz de Salud, Unidad de Tratamiento del Dolor con Técnicas Neuroestimulativas, Colonia Santa Inés-Teatinos Primary Health Care Centre,Málaga, Spaing Research Unit of Complementary Therapy, Universidad ‘‘Francisco de Miranda’’ Coro, Caracas, Venezuelah Instituto de Investigación de Salud y Terapéutica (INSYT), Caracas, Venezuela

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

a r t i c l e i n f o a b s t r a c t

Article history:Received 31 January 2012Received in revised form 20 April 2012Accepted 29 May 2012Available online xxxx

Keywords:AcupunctureAcute low back painPlaceboRandomised controlled trial

0304-3959/$36.00 � 2012 International Associationhttp://dx.doi.org/10.1016/j.pain.2012.05.033

⇑ Corresponding author. Address: Pain Treatment UHealth Care Centre, Cl. Segovia s/n. 41700, Dos954994850; fax: +34 954721500.

E-mail address: jorgef.vas.sspa@juntadeandalucia.e

Please cite this article in press as: Vas J et al. Ac(2012), http://dx.doi.org/10.1016/j.pain.2012.05

Reviews of the efficacy of acupuncture as a treatment for acute low back pain have concluded that thereis insufficient evidence for its efficacy and that more research is needed to evaluate it. A multicentre ran-domized controlled trial was conducted at 4 primary-care centres in Spain to evaluate the effects of acu-puncture in patients with acute nonspecific low back pain in the context of primary care. A total of 275patients with nonspecific acute low back pain (diagnosed by their general practitioner) were recruitedand assigned randomly to 4 different groups: conventional treatment either alone or complementedby 5 sessions over a 2-week period of true acupuncture, sham acupuncture, or placebo acupunctureper patient. Patients were treated from February 2006 to January 2008. The primary outcome was thereduction in Roland Morris Disability Questionnaire scores of 35% or more after 2 weeks’ treatment.The patients in the 3 types of acupuncture groups were blinded to the treatments, but those who receivedconventional treatment alone were not. In the analysis adjusted for the total sample (true acupuncturerelative risk 5.04, 95% confidence interval 2.24–11.32; sham acupuncture relative risk 5.02, 95% confi-dence interval 2.26–11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21–5.46),as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were betterthan conventional treatment alone, but there was no difference among the 3 acupuncture modalities,which implies that true acupuncture is not better than sham or placebo acupuncture.

� 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

1. Introduction

It has been claimed that 90% of patients with acute low backpain (LBP) recover within 6 weeks [22]. However, this seems exces-sively optimistic; although many patients do improve rapidly, therisk of the condition becoming chronic ranges 2–50% [8,19]. The 1-year prevalence of LBP among the adult population in Spain is 14%,and one third of patients experience a significant degree of pain [2],

for the Study of Pain. Published by

nit, Doña Mercedes PrimaryHermanas, Spain. Tel.: +34

s (J. Vas).

upuncture in patients with acu.033

although these data differ from those found in other Europeancountries [27]. The origin of 95% of cases of LBP is nonspecific[15], and treatment is usually conservative, with patients being ad-vised not to remain in bed, to follow body posture recommenda-tions, and to take analgesic medication such as paracetamol [22].In chronic LBP, acupuncture is associated with significantly greaterpain reduction than that achieved by placebo treatment [6]. How-ever, with respect to acute LBP, there remains insufficient evidenceas to its efficacy, and more research is needed to evaluate it [4,16].Moreover, there remain doubts as to whether acupuncture has aspecific effect [20].

The aim of this study was to compare the efficacy of acupunc-ture complementing conventional treatment with the resultsachieved by conventional treatment alone, and to investigate the

Elsevier B.V. All rights reserved.

te low back pain: A multicentre randomised controlled clinical trial. PAIN�

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specificity of acupuncture points applied to patients with nonspe-cific acute LBP.

2. Methods

2.1. Study design

Ours was a 4-branch multicentre study conducted at 4 primaryhealth care centres within the public health care system in Andalu-sia, Spain. Patients were included in the study during the periodfrom February 2006 to January 2007 and were treated within2 weeks after randomisation. The randomised allocation to the 4branches of the study was performed by a specialised computerprogram created for this purpose, at a central location (Departmentof Social Psychology, School of Psychology, University of Seville, Se-ville, Spain), following a 1:1:1:1 pattern (true acupuncture [TA],sham acupuncture [SA], placebo acupuncture [PA], conventionaltreatment [CT]), with 1 sequence for each centre, in blocks of 8, towhich the participating researchers were blinded. The patients inthe 3 acupuncture groups were blinded to the treatments, but theywere not blinded if they received only CT without acupuncture.

2.2. Participants

The patients included in this study were recruited by generalpractitioners (GPs) at primary health care centres within the publichealth care system in Andalusia. The criteria for inclusion were anew episode (defined as the first such episode in the last 6 months)of nonspecific LBP (defined as pain, muscle tension, or stiffness,localised below the costal margin and above the inferior glutealfolds, with or without referred or radicular leg pain) initiated lessthan 2 weeks previously, no prior experience of acupuncture treat-ment, patient’s age ranging from 18 to 65 years, and provision ofwritten informed consent. The following were criteria for exclu-sion: more than 1 absence from work as a result of LBP in the pre-vious 6 months; LBP attributed to recognisable, known specificpathology; generalised dermatopathologies; treatment with dic-oumarol anticoagulants; pregnancy; and inability or unwillingnessto complete the questionnaire or to answer the evaluator’squestions.

The patients were informed as follows: ‘‘This Centre is engagedin a study intended to evaluate and quantify the effects of conven-tional treatment, in isolation, compared to the same treatment ap-plied in combination with 2 types of acupuncture, one of thesebeing similar to traditional Chinese acupuncture, and the othernot following the same principles. In addition, there will be a con-trol group which will be given placebo acupuncture (in addition tothe conventional treatment). I have been told that I may be in-cluded in a random fashion (by means of a draw) in 1 of the 4 treat-ment groups.’’

2.3. Study interventions

The initial sample size was 70 patients per group [25]. The pa-tients were randomly assigned to the treatment groups—CT plusTA; CT plus SA; CT plus PA; and CT alone (analgesics, nonsteroidalanti-inflammatory drugs, myorelaxant drugs, posture recommen-dations)—by means of a telephone procedure for centralisedrandomisation.

The groups CT, SA, and PA were considered as control groups,with the latter 2 treatment options (SA and PA) being used todetermine the specificity of the acupuncture points and of thetechnique itself. Follow-up evaluations occurred at 3, 12, and48 weeks. Evaluation of the patients assigned to each of the 4 studygroups and analysis of the results were carried out by professionals

Please cite this article in press as: Vas J et al. Acupuncture in patients with acu(2012), http://dx.doi.org/10.1016/j.pain.2012.05.033

who were blinded to the assignment of the different treatment op-tions. The ethical validity of this study was determined by theAndalusian Committee for Clinical Trials. The study design hasbeen described in detail elsewhere [25].

The treatments applied were developed through a process ofconsensus and were implemented by physicians with at least700 h of training and a mean experience with acupuncture treat-ment of 8.5 years. The treatments with TA, SA, and PA consistedof five 20-min sessions over a period of 2 weeks. In summary,the TA treatment consisted in selecting individualised points onthe basis of pain characteristics and location; these points werethen punctured following the criteria of traditional Chinese medi-cine. In the SA treatment, nonspecific acupuncture points were se-lected for the treatment of LBP, and these points were puncturedfollowing the same procedure as for the previous group. In thePA group, points on the patient’s back were selected and momen-tary pressure applied with a semiblunted needle fitted within aguide tube, and with the patient adopting a face-down or lateralposition. The control group, as was the case for all participants inthe study, received CT in accordance with the indications of clinicalpractice guidelines for GPs. This consisted in informing the patientabout his or her situation, avoiding alarmism, and recommendinghim or her not to stay in bed but to remain as active as possible;advice was also given about potential warning signs and the possi-bility of pharmacological treatment (when prescribed by the GP):paracetamol (500–650 mg/6–8 h, maximum dose 4 g/day), ibupro-fen (400–600 mg/8 h), diclofenac (50 mg/8–12 h), and cyclobenza-prine (10 mg/6–8 h, maximum 1 week); any such pharmacologicaltreatment adopted would be recorded on the patient’s referralform [22].

Treatment credibility was assessed 1 week after starting theacupuncture intervention (TA, SA, PA) with the 4-item Borkovecand Nau Scale, evaluated with a continuous visual analogue scale(0 = totally disagree, 10 = totally agree) [1]. The participants wererequested not to obtain any other treatment for their LBP duringthe intervention and follow-up periods. Any additional treatmentduring this period was recorded.

2.4. Outcome measurements

The principal outcome measure was taken to be the clinicallyrelevant improvement in LBP at 3 weeks after randomisation, thisterm being defined as a reduction of 35% or more on the 24-pointRoland Morris Disability Questionnaire (RMQ) [13]. Secondary re-sult outcomes were pain intensity (visual analogue scale 0–100 mm) [26], disability (relative change in RMQ), occupationaldisability due to LBP, persistence of the initial LBP, appearance ofnew episodes of LBP, and improvement perceived by the patient[9]. Secondary outcomes were recorded at baseline and at 3, 12,and 48 weeks. At baseline, in addition, fear of LBP and conduct toavoid LBP were evaluated with the Fear Avoidance Beliefs Ques-tionnaire (FABQ) [14]. Collateral effects and possible adverse reac-tions arising from the treatment were all recorded.

2.5. Statistical analysis

A descriptive analysis was performed, in which means and stan-dard deviations were calculated for the quantitative variables andfrequency distributions for the qualitative ones. To evaluate theefficacy of TA complementing CT (analysis per intention to treat[ITT]), to determine the specificity of acupuncture points, to assessthe credibility of the patients with respect to the 3 types of acu-puncture provided, and to perform effective patient follow-up(per-protocol [PP] analysis) the chi-square test, with Yates’s cor-rection for continuity, or Fisher’s exact test were used. The

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Mann-Whitney nonparametric U test was used to evaluate pair-wise differences between groups. Imputation of missing data wascarried out by classifying these subjects as having no response.As a complementary activity, logistic regression analysis was per-formed with all the patients to evaluate efficacy per ITT, with aninitial step including the 4 (entry) branches of the study. Baselinevalues were used as a substitute for missing data. The second stepincluded sex, mean-centered age (difference between age andaverage age) educational level, paid work, prior episodes of LBPduring the last 2 years, length (in days) of duration of LBP, baselinepain, FABQ–Activity subscale, baseline irradiated pain, baseline legelevation of >60�, treatment with cyclobenzaprine, diclophenac,ibuprofen, and paracetamol, together with any increase in medica-tion dose in the last 3 weeks (conditional forward selection). Inaddition, a second logistic regression analysis was carried out forthe subgroup of working patients, adding to the above variablesthose of satisfaction in the workplace, occupational incapacity(OI) due to LBP in the last 2 years, OI due to LBP at the beginningof treatment, type of occupational activity, and FABQ–Work sub-scale. The decision to assess this subgroup was taken in order toadjust for occupational activity (evaluated with the FABQ occupa-tional subscale), which is a possible confounder of the results forthe principal variable being studied. The level of statistical signifi-cance was set at P < .05, and included the relative risk and therespective 95% confidence intervals (CIs).

3. Results

Fig. 1 shows the study flow chart. From February 2006 to Janu-ary 2008, the participating GPs referred a total of 381 potential

381 Individuals assessed for final eligibility

275 randomised and registered into the trial

68 assigned to the true acupuncture group

68 assigned to the sham acupuncture

group

6pl

Patiens completing follow-up64 3 weeks51 12 weeks51 48 weeks

Patiens completing follow-up65 3 weeks58 12 weeks53 48 weeks

Pafoll64 51 49

Fig. 1. Study fl

Please cite this article in press as: Vas J et al. Acupuncture in patients with acu(2012), http://dx.doi.org/10.1016/j.pain.2012.05.033

participants to the study, of whom 106 were excluded. Thus, 275patients were finally randomised, and none needed to withdrawor was excluded as a result of secondary LBP.

Table 1 lists the sociodemographic data for the patients andtheir baseline clinical characteristics. Almost half of the samplehad no more than primary education. Seventy-five percent of theparticipants had a paid job, and 52% of them claimed to take regu-lar physical exercise. Of the patients with paid work, half reporteda high degree of occupational satisfaction (scoring 5 or 6 on a 7-point Likert scale). The patients had a high mean baseline painintensity level (70.4 mm on a scale of 100 mm), an index of fearavoidance beliefs related to physical activity of 18.8 (standarddeviation [SD] 5.6), and related to work of 24.3 (SD 9.8). The meanduration of the episode for which they were included in the studywas 6 days (SD 3.7), and 61.7% of those who worked were currentlyoff work as a result of an episode of LBP at the time they enteredthe study.

There were no statistically significant differences between thegroups treated with any of the classes of acupuncture with respectto the patients’ confidence in the treatment received and theirexpectations of improvement. In this respect, over 80% of the sub-jects in these 3 groups were in strong agreement, scoring 8 or morepoints for the 4 items in question.

Table 2 lists the results obtained for the principal variable, thatof clinically relevant improvement, defined as a increase of 35% ormore on the baseline results in the RMQ in the ITT analysis. In theTA group, 73.5% of the subjects obtained an improvement in theirRMQ baseline value, in comparison with 75% of the SA group, 65.2%of the PA group, and 44.3% of the CT group. The differencesbetween the acupuncture and CT groups were statistically signifi-

106 excluded92 did not meet inclusion criteria

9 Refused consent5 Presented a complicated pathology

9 assigned to the acebo acupuncture

group

70 assigned to the Control group

tiens completing ow-up3 weeks12 weeks48 weeks

Patiens completing follow-up68 3 weeks60 12 weeks57 48 weeks

ow chart.

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Table 1Demographic and baseline clinical characteristics of study participants.a

Characteristic TA SA PA CT(n = 68) (n = 68) (n = 69) (n = 70)

Sex (female) 43 (63.2%) 39 (57.4%) 34 (49.3%) 45 (64.3%)Age 41.9 (10.3) 44.0 (9.4) 43.6 (12.2) 41.2 (12.0)

Educational levelNo qualifications 11 (16.2) 3 (4.4) 10 (14.5) 4 (5.7)Primary education 35 (51.5) 30 (44.1) 33 (47.8) 32 (45.7)Secondary education 12 (17.6) 21 (30.9) 22 (31.9) 29 (41.4)University education 10 (14.7) 14 (20.6) 4 (5.8) 5 (7.1)

Paid workNo 19 (27.9) 14 (20.6) 23 (33.3) 13 (18.6)Yes 49 (72.1) 54 (79.4) 46 (66.7) 57 (81.4)

Occupational satisfaction b

Unsatisfied 10 (20.4) 14 (25.9) 16 (34.8) 12 (21.1)Indifferent/satisfied 39 (79.6) 40 (74.1) 30 (65.2) 45 (78.9)

Regular physical exerciseNo 35 (51.5) 31 (45.6) 34 (49.3) 32 (45.7)Yes 33 (48.5) 37 (54.4) 35 (50.7) 38 (54.3)

LBP during previous 2 yearsNo 24 (35.3) 32 (47.1) 32 (46.4) 34 (48.6)Yes 44 (64.7) 36 (52.9) 37 (53.6) 36 (51.4)

Off work due to LBP in last 2 years b

No 38 (77.6) 44 (81.5) 39 (84.8) 43 (75.4)Yes 11 (22.4) 10 (18.5) 7 (15.2) 14 (24.6)

Currently off work due to LBP b

No 20 (40.8) 22 (40.7) 25 (54.3) 12 (21.1)Yes 29 (59.2) 32 (59.3) 21 (45.7) 45 (78.9)

Occupational activity b

Physically demanding 26 (53.1) 29 (53.7) 27 (58.7) 38 (66.7)Moderate 12 (24.5) 14 (25.9) 15 (32.6) 15 (26.3)Sedentary 11 (22.4) 11 (20.4) 4 (8.7) 4 (7.0)Pain intensity (VAS) 72.4 (14.9) 71.5 (18.3) 68.3 (19.5) 69.5 (18.0)Duration of current episode of LBP (d) 5.9 (2.9) 5.0 (3.6) 6.5 (4.1) 6.8 (3.9)RMQ 13.4 (4.6) 12.6 (6.3) 14.1 (5.2) 12.4 (5.1)

FABQActivity subscale 18.7 (5.5) 17.8 (6.4) 19.6 (5.6) 19 (4.8)Work subscale b 22.3 (10.6) 24.0 (9.9) 25.4 (9.2) 25.5 (9.4)Total b 54.5 (16.8) 55.7 (18.0) 59.1 (15.2) 59.3 (15.6)

Irradiated painNo 26 (38.2) 29 (42.6) 25 (36.2) 28 (40.0)Yes 42 (61.8) 39 (57.4) 44 (63.8) 42 (60.0)

Leg elevation capability<30� 1 (1.5) 4 (5.9) 4 (5.8) 0 (0)30–60� 21 (30.9) 13 (19.1) 14 (20.3) 18 (25.7)>60� 46 (67.6) 51 (75.0) 51 (73.9) 52 (74.3)

CyclobenzaprineNo 44 (64.7) 48 (70.6) 41 (59.4) 47 (67.1)Yes 24 (35.3) 20 (29.4) 28 (40.6) 23 (32.9)

DiclophenacNo 43 (63.2) 55 (80.9) 49 (71.0) 43 (61.4)Yes 25 (36.8) 13 (19.1) 20 (29.0) 27 (38.6)

IbuprofenNo 34 (50.0) 25 (36.8) 38 (55.1) 35 (50.0)Yes 34 (50.0) 43 (63.2) 31 (44.9) 35 (50.0)

ParacetamolNo 52 (76.5) 44 (64.7) 42 (60.9) 55 (78.6)Yes 16 (23.5) 24 (35.3) 27 (39.1) 15 (21.4)

LBP, low back pain; VAS, visual analogue scale, from 0 (no pain) to 100 (worst pain possible); RMQ, Roland Morris questionnaire, scored from 0 (no disability) to 24 (highdisability); FABQ–Activity, Fear Avoidance Beliefs Questionnaire–Activity, scored from 0 (no fear avoidance beliefs) to 24 (high fear avoidance beliefs); FABQ–Work, FearAvoidance Beliefs Questionnaire–Work, scored from 0 (no fear avoidance beliefs) to 42 (high fear avoidance beliefs).

a Data are n (%) or mean (standard deviation).b Data are for 49 patients in group A, 54 in group B, 46 in group C, and 57 in group D.

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cant. The results did not vary in the PP analysis, but the differencesbetween the TA and PA groups were significant.

After adjusting for occupational satisfaction and the use of dicl-ophenac in the working population subsample (Table 3), the rela-tive risk for efficacy was found to be 6.58 (95% CI 2.46–17.56) in

Please cite this article in press as: Vas J et al. Acupuncture in patients with acu(2012), http://dx.doi.org/10.1016/j.pain.2012.05.033

the TA group, 5.72 (95% CI 2.27–14.43) in the SA group, and 3.92(95% CI 1.57–9.76) in the PA group, with respect to the CT group.For the total sample (Table 4), after adjusting for age, change indose after 3 weeks, and use of diclophenac, the relative risk forefficacy was 5.04 (95% CI 2.24–11.32) in the TA group, 5.02 (95%

te low back pain: A multicentre randomised controlled clinical trial. PAIN�

Table 2Efficacy.a

CRI TA SA PA CT P(n = 68) (n = 68) (n = 69) (n = 70) TA vs SA TA vs PA TA vs CT

No 18 (26.5%) 17 (25.0%) 24 (34.8%) 39 (55.7%) 1.000 .384 .001Yes 50 (73.5%) 51 (75.0%) 45 (65.2%) 31 (44.3%) . . . . . . . . .

CRI, clinically relevant improvement; TA, true acupuncture; SA, sham acupuncture; PA, placebo acupuncture; CT, conventional treatment.a Chi-square correction for continuity. CRI indicates P35% improvement on the Roland Morris Disability Questionnaire results.

Table 3CRI logistic regression (206 workers) at 3 weeks (analysis per ITT).

Characteristic Raw Adjusted

RR 95% CI low value 95% CI high value RR 95% CI low value 95% CI high value

GroupCT 1 1TA 5.45 2.21 13.43 6.58 2.46 17.56SA 3.51 1.56 7.90 5.72 2.27 14.43PA 2.58 1.12 5.95 3.92 1.57 9.76

Occupational satisfactionUnsatisfied 1 1Indifferent/satisfied 3.78 1.90 7.52 4.40 2.07 9.35

Baseline diclophenacNo 1 1Yes 2.22 1.15 4.31 2.56 1.20 5.48

CRI, clinically relevant improvement; ITT, intention to treat; RR, relative risk; CI, confidence interval; CT, conventional treatment; TA, true acupuncture; SA, sham acu-puncture; PA, placebo acupuncture.

Table 4CRI logistic regression (275 patients) at 3 weeks (analysis per ITT).

Characteristic Raw Adjusted

RR 95% CI low value 95% CI high value RR 95% CI low value 95% CI high value

GroupCT 1 1TA 4.80 2.24 10.30 5.04 2.24 11.32SA 3.80 1.82 7.90 5.02 2.26 11.16PA 2.24 1.11 4.50 2.57 1.21 5.46

Age (mean-centered age[difference between age and average age])

0.97 0.95 0.99 0.96 0.94 0.99

Medication dose at 3 wkNone, lower, or unchanged 1 1Higher 0.15 0.04 0.57 0.18 0.04 0.76

Baseline diclophenacNo 1 1Yes 1.88 1.06 3.34 2.00 1.06 3.80

CRI, clinically relevant improvement; ITT, intention to treat; RR, relative risk; CI, confidence interval; CT, conventional treatment; TA, true acupuncture; SA, sham acu-puncture; PA, placebo acupuncture.

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CI 2.26–11.16) in the SA group, and 2.57 (95% CI 1.21–5.46) in thePA group with respect to CT.

Table 5 lists the behaviour of the 4 groups for the secondary out-come variables measured at the end of treatment, and after 3 and12 months’ follow-up. Sixty-three participants (98.4%) in the TAgroup, 62 (95.4%) in the SA group, 63 (98.4%) in the PA group, and60 (88.2%) who underwent CT were taking the same, less, or no med-ication at 3 weeks after beginning treatment. Specifically, 40.6% to60% of the patients in the acupuncture groups were not taking anymedication at the end of treatment, in contrast to 25% of the CT pa-tients. The change in RMQ between the baseline evaluation and after3 weeks was 63.9 (SD 40.4) in the TA group, 65.0 (40.5) in the SAgroup, 43.1 (58.9) in the PA group, and 26.6 (58.9) in the CT group;the differences were statistically significant for the comparisons TAvs PA (P = .02) and TA vs CT (P < .001). At 3 weeks, 6.4% of the patientsin the TA group were off work, in contrast to 30.9% of the CT group

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(P = .004). In relation to the initial pain, only 27.9% of the CT patients,at 3 weeks after randomisation, stated they were free of pain. Thispercentage was greater for the SA patients (49.2%), for those in thePA group (29.7%), and for those in the TA group (53.1%). The differ-ences between the TA, PA, and CT groups were statistically signifi-cant (P = .012 and P = .006 respectively). At 3 months afterrandomisation, LBP was still experienced by 18.1% of the sample, dis-tributed as follows: 9.8% of the participants in the TA group, 13.8% ofthose in the SA group, 21.6% of those in the PA group, and 16.7% ofthose in the CT group. Finally, at 1 year after beginning the study,pain was still experienced by 4.4% of the sample, distributed amongthe treatment groups as follows: 0% in the TA group, 13.2% in the SAgroup, 6.1% in the PA group, and 0% in the CT group. The differencesbetween the TA and SA groups were significant (P = .013). No signif-icant differences were found among the 3 acupuncture groupsregarding expectations and confidence in the treatment.

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Table 5Follow-up (chi-square correction for continuity).a

Characteristic TA SA PA CT P

TA vs SA TA vs PA TA vs CT

Medication dose at 3 wk after starting treatmentNone, lower or unchanged 63 (98.4) 62 (95.4) 63 (98.4) 60 (88.2) .619 * 1.000 * .033 *

Higher 1 (1.6) 3 (4.6) 1 (1.6) 8 (11.8)

RMQ changeRMQ (T0–T1) 63.9 (40.4) 65.0 (40.5) 43.1 (58.9) 26.6 (58.9) .707 ** .020 ** <.001 **

RMQ (T0–T2) 91.6 (17.1) 84.7 (28.9) 76.3 (41.5) 83.0 (23.2) .792 ** .251 ** .099 **

RMQ (T0–T3) 67.4 (74.0) 75.6 (37.4) 70.7 (55.4) 63.3 (57.4) .447 ** .994 ** .455 **

OI due to LBP (final)No 44 (93.6) 45 (90.0) 37 (90.2) 38 (69.1) .716 * .700 * .004Yes 3 (6.4) 5 (10.0) 4 (9.8) 17 (30.9)

OI due to LBP (3-mo follow-up)No 39 (100) 45 (95.7) 35 (97.2) 50 (100) .498 * .480 * . . .

Yes 0 (0.0) 2 (4.3) 1 (2.8) 0 (0.0)

OI due to LBP (12-mo follow-up)No 35 (89.7) 43 (100) 30 (88.2) 40 (83.3) .047 * 1.000 * .583Yes 4 (10.3) 0 (0.0) 4 (11.8) 8 (16.7)

Continuing pain from initial LBP episode? (end of follow-up)No 34 (53.1) 32 (49.2) 19 (29.7) 19 (27.9) .790 .012 .006Yes 30 (46.9) 33 (50.8) 45 (70.3) 49 (72.1)

Continuing pain from initial LBP episode? (3-mo follow-up)No 46 (90.2) 50 (86.2) 40 (78.4) 50 (83.3) .730 .173 .438Yes 5 (9.8) 8 (13.8) 11 (21.6) 10 (16.7)

Continuing pain from initial LBP episode? (12-mo follow-up)No 51 (100) 46 (86.8) 46 (93.9) 57 (100) .013 * .114 * . . .

Yes 0 (0.0) 7 (13.2) 3 (6.1) 0 (0.0)

CRI (3-mo follow-up)No 1 (2.0%) 6 (10.3%) 10 (19.6%) 3 (5.0%) .164 .011 .730Yes 50 (98.0%) 52 (89.7%) 41 (80.4%) 57 (95.0%)

CRI (12-mo follow-up)No 7 (13.7%) 6 (11.3%) 8 (16.3%) 13 (22.8%) .941 .933 .335Yes 44 (86.3%) 47 (88.7%) 41 (83.7%) 44 (77.2%)

Recurrence of initial LBP episode (3-mo follow-up)No 48 (94.1%) 52 (89.7%) 48 (94.1%) 54 (90.0%) .498 * 1.000 * .503Yes 3 (5.9%) 6 (10.3%) 3 (5.9%) 6 (10.0%)

New episodes of LBP (12-mo follow-up)No 25 (49.0) 30 (56.6) 24 (49.0) 23 (41.1) .563 1 .528Yes 26 (51.0) 23 (43.4) 25 (51.0) 33 (58.9)

TA, true acupuncture; SA, sham acupuncture; PA, placebo acupuncture; CT, conventional treatment; RMQ, Roland Morris Disability Questionnaire; T0, baseline; T1, final; T2,3-month follow-up; T3, 12-month follow-up; OI, occupational incapacity; LBP, low back pain; CRI, clinically relevant improvement.

a Data are n (%) or mean (standard deviation).* Fisher’s test.

** Mann-Whitney U test.

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No serious adverse reaction was recorded in any of the treat-ment groups. Twelve patients (4.4%) had possible adverse reactionsto medication including epigastralgias and nausea, 1 in the TAgroup, 1 in the SA group, 4 in the PA group, and 6 in the CT group.With respect to adverse effects provoked by all classes of acupunc-ture treatment, 8 patients (3.9%) reported increased pain after thetreatment session, 3 in the TA group, 3 in the SA group, and 2 in thePA group.

4. Discussion

The results obtained indicate that TA associated with CT, byboth ITT and PP analysis, is more effective than CT alone. However,there were no differences among the different types of treatmentwith acupuncture (TA, SA, and PA) associated with CT, althoughclinically relevant improvement with respect to CT alone wasachieved after 3 weeks. Nevertheless, the study was only poweredto detect differences between the TA and CT groups. These resultswere unchanged after adjusting for the secondary variables of‘‘continuing occupational incapacity’’ and ‘‘proportion of pain-free

Please cite this article in press as: Vas J et al. Acupuncture in patients with acu(2012), http://dx.doi.org/10.1016/j.pain.2012.05.033

subjects at 3 weeks.’’ Data analysis revealed a lesser need for anal-gesics and nonsteroidal anti-inflammatory drugs, together with abetter reaction to the initial pain and its consequences (OI) amongthe 3 acupuncture groups than with CT.

PA presents statistically significant differences with respect toindividualised acupuncture for proportions of pain-free patientsafter 3 weeks’ treatment, and values close to significance at3 months and 1 year. The only difference found between TA andSA concerned the long-term effect (at 1 month), with a greater pro-portion of patients being pain-free among the TA group.

The statistical strength of the present study is based on theeffective, appropriate blinding carried out with respect to the studysubjects, as indicated by the fact that, regarding the level of confi-dence in the acupuncture treatment, there were no significant dif-ferences among the groups at 1 week after the initial intervention.The blinding was equally effective with respect to the evaluation ofclinical parameters and data analysis, and to the efficacy and objec-tivity of the principal outcome measure in evaluating treatment re-sponse via the RMQ, which is a well-validated instrument thatcorroborates the reliability and reproducibility of the data

te low back pain: A multicentre randomised controlled clinical trial. PAIN�

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presented. In addition, the use of the RMQ confers practical signif-icance thanks to the use of specific clinical criteria for LBP [11,21].Other notable strengths of this study are that it is adequately pow-ered to detect a clinically significant difference in the primary out-come between the TA and CT groups; it is randomized, and semi–participant blinded; dropout rates were low; both short- and long-term follow-up were carried out; measures of various secondaryoutcomes were obtained; and both ITT and PP analyses are re-ported. On the other hand, although the participants in the 3 acu-puncture groups did not know which type of acupuncture theywere receiving (TA, SA, or PA), there was no blinding between CTalone and treatment with acupuncture, which could be considereda weakness in this study.

Many clinical studies and meta-analyses have confirmed thewell-known, and reproducible, efficacy of acupuncture for casesof chronic LBP [3,23]. However, meta-analyses often produce con-tradictory results, in favour of or against acupuncture, or concludethat TA is no better than SA, although both outperform conven-tional medication [5,16,24]. It is noteworthy that our data for acuteLBP are analogous to those for chronic LBP reported in a large-scaleGerman study, in which, at 6 months, the positive response ratewas 47.6% for the TA group, 44.2% for the SA group, and 27.4%for the CT group; the magnitude of the beneficial effect of acupunc-ture, real or sham, was almost twice that of CT [7]. Similarly, Ken-nedy et al., in a pilot study that used PA as a control treatment foracute LBP, found no differences between the group treated withacupuncture and the control group, although there was a reductionin demand for analgesic medication [12].

Any type of peripheral sensorial stimulus, including tactilestimulus, is capable of stimulating multimodal receptors of theC-fibre primary afferents, which can modulate the limbic systemat the insula and thus reduce the affective component of pain[10]. Therefore, the interventions applied in the SA and PA groupscannot be considered inert. The participants in the 3 acupuncturegroups received special attention, apart from the sensory stimulusin itself, which was not the case with those receiving only CT, andthis could have contributed to reducing the symptoms of LBP. Thisextra attention included the contextual effects of greater physi-cian–patient interaction (5 visits in 2 weeks), the therapeutic rit-ual, and the tactile stimulus of the physician’s hands [17]. Alsowell known is the effect of positive expectations on the results ofacupuncture studies in pain-relief treatment [18].

In consequence, the association of TA with CT results in a great-er improvement being obtained by patients with nonspecific acuteLBP at 3 weeks after beginning treatment, even though no differ-ences were observed among TA, SA, and PA. Although, in view ofthe multivariate models analysed, patients treated with TA re-sponded better than with SA or PA, we found no statistically signif-icant differences to support the idea that the selection ofacupuncture points following the criteria of traditional Chinesemedicine has any influence on short-term results in the treatmentof acute LBP. The differences between TA and the SA and PA groupscould be interpreted as being dependent on the intensity of thestimulus applied.

Conflict of interest statement

The authors report no conflict of interest.

Acknowledgements

The trial was funded by the Spanish Ministry of Health and Con-sumer Affairs (Carlos III Health Institute) and by the AndalusianPublic Health System.

Please cite this article in press as: Vas J et al. Acupuncture in patients with acu(2012), http://dx.doi.org/10.1016/j.pain.2012.05.033

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