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array:22 [ "pii" => "S1413355518305410" "issn" => "14133555" "doi" => "10.1016/j.bjpt.2018.09.002" "estado" => "S300" "fechaPublicacion" => "2019-09-01" "aid" => "152" "copyright" => "Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia" "copyrightAnyo" => "2018" "documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "cita" => "Braz J Phys Ther. 2019;23:448-57" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 1165 "formatos" => array:3 [ "EPUB" => 120 "HTML" => 693 "PDF" => 352 ] ] "itemAnterior" => array:18 [ "pii" => "S1413355518305203" "issn" => "14133555" "doi" => "10.1016/j.bjpt.2018.10.008" "estado" => "S300" "fechaPublicacion" => "2019-09-01" "aid" => "169" "copyright" => "Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia" "documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "cita" => "Braz J Phys Ther. 2019;23:437-47" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 900 "formatos" => array:3 [ "EPUB" => 99 "HTML" => 485 "PDF" => 316 ] ] "en" => array:12 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Original Research</span>" "titulo" => "The interrater reliability of a pain mechanisms-based classification for patients with nonspecific neck pain" "tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "en" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "437" "paginaFinal" => "447" ] ] "contieneResumen" => array:1 [ "en" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Vincent Dewitte, Robby De Pauw, Lieven Danneels, Katie Bouche, Arne Roets, Barbara Cagnie" "autores" => array:6 [ 0 => array:2 [ "nombre" => "Vincent" "apellidos" => "Dewitte" ] 1 => array:2 [ "nombre" => "Robby" "apellidos" => "De Pauw" ] 2 => array:2 [ "nombre" => "Lieven" "apellidos" => "Danneels" ] 3 => array:2 [ "nombre" => "Katie" "apellidos" => "Bouche" ] 4 => array:2 [ "nombre" => "Arne" "apellidos" => "Roets" ] 5 => array:2 [ "nombre" => "Barbara" "apellidos" => "Cagnie" ] ] ] ] "resumen" => array:1 [ 0 => array:3 [ "titulo" => "Highlights" "clase" => "author-highlights" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0005" class="elsevierStylePara elsevierViewall">Nonspecific neck pain patients can be classified based on pain mechanisms.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0010" class="elsevierStylePara elsevierViewall">The proposed classification strategy has clinically acceptable interrater reliability.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0015" class="elsevierStylePara elsevierViewall">The classification holds the potential to guide physical therapy interventions.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0020" class="elsevierStylePara elsevierViewall">Validity testing is the necessary next step to justify this approach for clinical use.</p></li></ul></p></span>" ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1413355518305203?idApp=UINPBA00007O" "url" => "/14133555/0000002300000005/v1_201909250858/S1413355518305203/v1_201909250858/en/main.assets" ] "en" => array:19 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Original Research</span>" "titulo" => "Description of low back pain clinical trials in physical therapy: a cross sectional study" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "448" "paginaFinal" => "457" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Dafne Port Nascimento, Gabrielle Zoldan Gonzalez, Amanda Costa Araujo, Leonardo Oliveira Pena Costa" "autores" => array:4 [ 0 => array:4 [ "nombre" => "Dafne Port" "apellidos" => "Nascimento" "email" => array:1 [ 0 => "dafnepn@yahoo.com.br" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "Gabrielle Zoldan" "apellidos" => "Gonzalez" ] 2 => array:2 [ "nombre" => "Amanda Costa" "apellidos" => "Araujo" ] 3 => array:2 [ "nombre" => "Leonardo Oliveira Pena" "apellidos" => "Costa" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author at: Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno 448, Tatuapé, CEP 03071-000, São Paulo, SP, Brazil." ] ] ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2140 "Ancho" => 2333 "Tamanyo" => 162205 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Flow chart of included randomized controlled trials.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Introduction</span><p id="par0025" class="elsevierStylePara elsevierViewall">Low back pain is the leading cause of years lived with disability since 1990,<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">1</span></a> with a high prevalence and costs worldwide.<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">2–5</span></a> Low back pain affects not only high income countries, but also high middle income and middle socio-demographic index countries.<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">1</span></a> In order to measure treatment effectiveness for this condition, the best evidence is provided by randomized controlled trials or systematic reviews of randomized controlled trials.<a class="elsevierStyleCrossRefs" href="#bib0210"><span class="elsevierStyleSup">6,7</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The usual treatment for low back pain patients is consisted of nonpharmacologic therapies, education, reassurance and analgesic medication.<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">8</span></a> Nonpharmacologic therapies have shown effectiveness on mind-body interventions, such as exercise, psychological therapies, multidisciplinary rehabilitation, spinal manipulation, massage and acupuncture.<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">9</span></a> Such interventions reinforce the essential role carried by physical therapists in the long-term management of this condition.<a class="elsevierStyleCrossRef" href="#bib0230"><span class="elsevierStyleSup">10</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">In order to implement treatments for low back pain, randomized controlled trials should follow adequate reporting and methodological guidelines.<a class="elsevierStyleCrossRef" href="#bib0235"><span class="elsevierStyleSup">11</span></a> The methodological quality of physical therapy randomized controlled trials varies across different subdisciplines.<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">12</span></a> The methodological quality of trials in musculoskeletal physical therapy has been associated with endorsement of reporting recommendations (i.e. trials/journals that formally ask authors to report their trials using the Consolidated Standards of Reporting Trials, CONSORT<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">13</span></a>), articles published recently and trials published in English.<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">14</span></a> On the other hand, the methodological quality is not necessarily associated with journal Impact Factor.<a class="elsevierStyleCrossRef" href="#bib0255"><span class="elsevierStyleSup">15</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">The Physiotherapy Evidence Database (PEDro; <a href="http://www.pedro.org.au/"><span class="elsevierStyleItalic">www.pedro.org.au</span></a>) is an open access database that indexes clinical trials, systematic reviews and guidelines in physical therapy.<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">16</span></a> PEDro is one of the four most comprehensive healthcare databases, including CENTRAL, PubMed and EMBASE, but only PEDro is focused only in physical therapy interventions.<a class="elsevierStyleCrossRefs" href="#bib0265"><span class="elsevierStyleSup">17,18</span></a> Each clinical trial indexed on PEDro goes through a methodological quality and statistical reporting assessment measured by the PEDro scale,<a class="elsevierStyleCrossRefs" href="#bib0275"><span class="elsevierStyleSup">19–22</span></a> which generates a score that ranges from 0 (low methodological quality) to 10 (high methodological quality). The items from the PEDro scale are: (1) eligibility criteria and source (not included on the total score); (2) random allocation; (3) concealed allocation; (4) baseline comparability; (5) blinding of subjects; (6) blinding of therapists; (7) blinding of assessors; (8) adequate follow-up; (9) intention-to-treat analysis; (10) between-group comparisons; (11) point estimates and variability.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Clinicians treating low back pain patients should be aware about what would be the core journals that publish randomized controlled trials in physical therapy for low back pain. In addition, it is important to understand the strengths and weaknesses of those trials.<a class="elsevierStyleCrossRef" href="#bib0235"><span class="elsevierStyleSup">11</span></a> Therefore, the primary objective of this study was to describe the main characteristics of low back pain randomized controlled trials on PEDro, and to rank the journals where these trials were published according to their Impact Factor. Our secondary objective was to analyze the correlation between trials methodological quality and journals Impact Factor.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Study selection</span><p id="par0050" class="elsevierStylePara elsevierViewall">We searched for all low back pain randomized controlled trials, published between 2010 and 2015, and indexed on PEDro database on February 1st 2016. Then we randomly selected a sample of approximately 40% of all eligible trials, using the random number function in Excel. The eligibility criteria were: full-published articles; written in English, Spanish or Portuguese; and published between 2010 and 2015. The languages were restricted to English, Spanish and Portuguese, as they are languages spoken by the authors of this manuscript and are within the most published languages on PEDro.<a class="elsevierStyleCrossRefs" href="#bib0250"><span class="elsevierStyleSup">14,23</span></a> Trials that were still in the recruitment stages, protocols, duplicates and those involving any topic other than low back pain were excluded. We used the advanced search strategy on PEDro, as follows: “clinical trial” for method; “lumbar spine, sacroiliac joint or pelvis” for body part; “pain” for problem; and 2010–2015 for year of publication.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Data extraction</span><p id="par0055" class="elsevierStylePara elsevierViewall">One independent author extracted data in an Excel spreadsheet previously formatted to describe the trials’ characteristics. Data extracted from the trials were: (1) continent where trial was conducted; (2) language of publication, categorized into English or non-English; (3) methodological quality, which was measured by total PEDro score and downloaded from PEDro database (0–10 points with higher values indicating better methodological quality); (4) number of years since publication, calculated by subtracting the year of publication from 2015; (5) number of citations normalized by the number of years since publication (extracted from the Web of Science Clarivate Analytics); (6) total sample size (i.e., number of participants randomized); (7) primary outcomes, which were collected at most two outcomes. For articles that did not specify the primary outcome, but had two outcomes mentioned only, we considered both as primary. For articles that did not specify the primary outcome but had more than two outcomes, we considered “pain” and “disability” as primary.<a class="elsevierStyleCrossRef" href="#bib0300"><span class="elsevierStyleSup">24</span></a> In the cases which the article did not have any of these two outcomes, we collected the first two mentioned by the authors. All primary outcomes were categorized into: pain, disability, function, quality of life or other; (8) interventions, which included any type of physical therapy intervention. Each intervention was categorized according to the intervention codes used by PEDro<a class="elsevierStyleCrossRef" href="#bib0305"><span class="elsevierStyleSup">25</span></a> (i.e., Acupuncture; Behavior modification; Education; Electrotherapy, heat, cold; Fitness training; Health promotion; Hydrotherapy, balneotherapy; Neurodevelopmental therapy, neurofacilitation; Ortheses, taping, splinting; Respiratory therapy; Skill training; Strength training; Stretching, mobilization, manipulation, massage; No appropriate value in this field); (9) comparators, which were categorized into no-treatment control,<a class="elsevierStyleCrossRef" href="#bib0310"><span class="elsevierStyleSup">26</span></a> placebo,<a class="elsevierStyleCrossRef" href="#bib0315"><span class="elsevierStyleSup">27</span></a> addition of other treatment,<a class="elsevierStyleCrossRef" href="#bib0320"><span class="elsevierStyleSup">28</span></a> waiting list,<a class="elsevierStyleCrossRef" href="#bib0325"><span class="elsevierStyleSup">29</span></a> minimal intervention,<a class="elsevierStyleCrossRef" href="#bib0320"><span class="elsevierStyleSup">28</span></a> usual care<a class="elsevierStyleCrossRef" href="#bib0330"><span class="elsevierStyleSup">30</span></a> and/or other intervention.<a class="elsevierStyleCrossRef" href="#bib0335"><span class="elsevierStyleSup">31</span></a> We also classified the trial in one of these groups if the authors of the trial classified the comparator group as such.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Data extracted from journals were: (1) 2015 journal Impact Factor (from the Web of Science, InCites Journal Citation Reports – Thomson Reuters’ website Clarivate Analytics), and categorized in three strata (Journals without Impact Factor; Journals with Impact Factor less than 2.0; Journals with Impact Factor more than 2.0); (2) if journal was open access (yes or no), which was obtained from the Directory of Open Access Journals, PubMed Central or the journal's web-site; and (3) if journal endorses the CONSORT recommendations<a class="elsevierStyleCrossRef" href="#bib0340"><span class="elsevierStyleSup">32</span></a> (yes or no), which was extracted from the “Instructions to authors” for each of the journals or from the CONSORT's website.<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">13</span></a></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Main outcome measures</span><p id="par0065" class="elsevierStylePara elsevierViewall">The main outcome measures were: journal Impact Factor; if the paper was published as open access; CONSORT recommendations endorsement by the journal; and methodological quality measured by total PEDro score.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Data analysis</span><p id="par0070" class="elsevierStylePara elsevierViewall">All trials characteristics were analyzed descriptively. Normality tests were conducted and all data were normally distributed, except for the total sample size, which was reported as median and interquartile range. The correlation between trials methodological quality and journals Impact Factor was calculated using Pearson correlation. We used SPSS software (Version 20.0) for all analyses.</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0075" class="elsevierStylePara elsevierViewall">The search strategy on PEDro database yielded 25.956 clinical trials. Using the advanced search strategy 537 potentially eligible trials were retrieved. A total of 67 were excluded as these trials were not eligible. From the remaining 470 articles, we randomly selected a sample of 200 trials, represented in the flow chart in <a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0080" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> presented the descriptive data of the 200 articles. Most of trials were conducted in Europe and Asia, published in English, in open access journals and more than half endorsed CONSORT recommendations.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0085" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a> presented the frequency and percentage of the primary outcomes, interventions and comparators. Most of trials evaluated pain and disability as primary outcomes; strength training, stretching, mobilization, manipulation and/or massage as interventions; and were mainly compared with other treatment or the addition of other treatment.</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0090" class="elsevierStylePara elsevierViewall">The 200 trials were published in 97 different journals. We organized the journals into: Impact Factor higher than 2.0 (30 journals with 81 articles); Impact Factor lower than 2.0 (40 journals with 76 articles); and journals without Impact Factor (27 journals with 43 articles) (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>). The top 3 journals were: (1) <span class="elsevierStyleItalic">British Medical Journal</span>; (2) <span class="elsevierStyleItalic">Annals of Internal Medicine</span>; and (3) <span class="elsevierStyleItalic">BMC Medicine</span>. As our results showed, the higher the journal Impact Factor, the higher the methodological quality of the trials, and apparently is also higher the likelihood of the journals to endorse CONSORT recommendations and offer open access (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>). Combining those four characteristics together (Impact Factor higher than 2.0, trial methodological quality higher than 6.0, endorse CONSORT recommendations and open access journal), the top 3 journals were: (1) <span class="elsevierStyleItalic">BMC Medicine</span>; (2) <span class="elsevierStyleItalic">Annals of Family Medicine</span>; and (3) <span class="elsevierStyleItalic">Journal of Medical Internet Research</span>. Interestingly, only three other journals from our sample also presented those four characteristics, which were the <span class="elsevierStyleItalic">Journal of Physiotherapy</span>, <span class="elsevierStyleItalic">PLoS ONE</span> and <span class="elsevierStyleItalic">BMC Pregnancy and Childbirth</span>.</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">Trials methodological quality and statistical reporting measured by the PEDro scale was weakly correlated with journals Impact Factor (<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.23; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.004).</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Main characteristics of low back pain trials</span><p id="par0100" class="elsevierStylePara elsevierViewall">Low back pain randomized controlled trials have been published in a variety of healthcare journals, with Impact Factors ranging from 0.4 to 19.7, and even in some journals that were not even indexed in the Web of Science. Most of these trials had moderate methodological quality (with a PEDro mean score of 5.8 points out of 10.0) and were published in open access journals that endorsed CONSORT recommendations. Similar to a previous study in musculoskeletal physical therapy,<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">14</span></a> our results indicate a positive, but weak correlation between methodological quality and Impact Factor. This means that high quality low back pain trials are not necessarily published in journals with high Impact Factor.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Low back pain trials characteristics and the literature</span><p id="par0105" class="elsevierStylePara elsevierViewall">The sample size showed a median of 73.5 participants (IQR 109, minimum 10–maximum 4.325), which shows that some studies analyzed a small group of participants, which probably did not reach the statistical power of detecting a clinical important difference among the intervention and control groups.<a class="elsevierStyleCrossRef" href="#bib0345"><span class="elsevierStyleSup">33</span></a></p><p id="par0110" class="elsevierStylePara elsevierViewall">The primary outcomes most evaluated by the trials were pain and disability, which agrees with the core outcome sets found in panel consensus for low back pain, together with quality of life.<a class="elsevierStyleCrossRef" href="#bib0350"><span class="elsevierStyleSup">34</span></a> The instruments mostly recommended for physical functioning are the Oswestry Disability Index and 24-item Roland-Morris Disability Questionnaire, and the Numerical Pain Rating Scale.<a class="elsevierStyleCrossRef" href="#bib0350"><span class="elsevierStyleSup">34</span></a> This shows that most of back pain researchers are aligned with these recommendations.</p><p id="par0115" class="elsevierStylePara elsevierViewall">The most frequent interventions analyzed in our sample were exercises (strength training and stretching), manual therapy and education, which are the main recommended interventions for low back pain according to the National Institute for Health and Care Excellence (NICE) guidelines,<a class="elsevierStyleCrossRef" href="#bib0355"><span class="elsevierStyleSup">35</span></a> and also to a recent low back pain series published by a panel of experts in the field.<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">2–4</span></a> Maybe authors should investigate further the effectiveness of interventions that were poorly or not investigated in these trials for low back pain and which do not present much evidence according to previously published guidelines,<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">2–4,35</span></a> such as hydrotherapy and neurodevelopment therapy, for example.</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Strengths and limitations</span><p id="par0120" class="elsevierStylePara elsevierViewall">A particular strength of our study is that we presented 30 possible options of high Impact Factor journals that published low back pain trials, from which six journals are highly recommended for reading and referred to when taking a clinical decision. Also, we are confident that we have a representative sample of low back pain trials published on PEDro in 2010–2015, once we selected 40% of the total ‘population’ of eligible trials. However, our main limitation is that some journals might have been missed and we could not generalize our results for all low back pain trials, including trials involving surgery or drug trials.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Clinical and methodological implications</span><p id="par0125" class="elsevierStylePara elsevierViewall">The analyzed trials comparing interventions for low back pain presented moderate methodological quality. Readers should be very cautious on taking clinical decisions based on poor methodological quality trials, which may increase the existing gap between evidence and practice.<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">2–4</span></a> The research efforts and global initiatives to treat this public health problem need also to focus on improving reporting and methodological quality for future studies. Although 55.5% of journals already endorse CONSORT recommendations, we suggest that the EQUATOR recommendations (Enhancing the QUAlity and Transparency Of health Research; <a href="https://www.equator-network.org/">https://www.equator-network.org/</a>) become mandatory requirements for publication, as well as following the items evaluated in methodological guidelines (e.g. Cochrane Risk of Bias tool or the PEDro scale<a class="elsevierStyleCrossRef" href="#bib0360"><span class="elsevierStyleSup">36</span></a>). Journal editors and peer reviewers should strictly follow those requirements in order to improve reporting and methodological quality of randomized controlled trials. Therefore, actions of better reporting and conducting the studies following adequate methodological guidelines will better address authors and journals editors/reviewers to write and publish more trustworthy studies.</p></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Conclusion</span><p id="par0130" class="elsevierStylePara elsevierViewall">Low back pain randomized controlled trials in the field of physical therapy presented moderate methodological quality. Our findings also show that trial quality was weakly correlated with Impact Factor. Clinicians interested in low back pain trials may look for a wide variety of healthcare journals. A substantial number of low back pain randomized controlled trials did not follow adequate reporting and methodological recommendations.</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Funding</span><p id="par0135" class="elsevierStylePara elsevierViewall">This work was supported by a scholarship from the <span class="elsevierStyleGrantSponsor" id="gs1">Sao Paulo Research Foundation</span> (FAPESP), under the process number of 2015/16953-2.</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Conflicts of interest</span><p id="par0140" class="elsevierStylePara elsevierViewall">The authors declare no financial competing interest. Furthermore, seven out of the 200 articles analyzed involved authors from our research groups or collaborators.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres1248745" "titulo" => "Highlights" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:3 [ "identificador" => "xres1248744" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0010" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0015" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0020" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0025" "titulo" => "Conclusion" ] ] ] 2 => array:2 [ "identificador" => "xpalclavsec1157842" "titulo" => "Keywords" ] 3 => array:2 [ "identificador" => "xpalclavsec1157843" "titulo" => "Abbreviations" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Methods" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Study selection" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Data extraction" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Main outcome measures" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Data analysis" ] ] ] 6 => array:2 [ "identificador" => "sec0035" "titulo" => "Results" ] 7 => array:3 [ "identificador" => "sec0040" "titulo" => "Discussion" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0045" "titulo" => "Main characteristics of low back pain trials" ] 1 => array:2 [ "identificador" => "sec0050" "titulo" => "Low back pain trials characteristics and the literature" ] 2 => array:2 [ "identificador" => "sec0055" "titulo" => "Strengths and limitations" ] 3 => array:2 [ "identificador" => "sec0060" "titulo" => "Clinical and methodological implications" ] ] ] 8 => array:2 [ "identificador" => "sec0065" "titulo" => "Conclusion" ] 9 => array:2 [ "identificador" => "sec0070" "titulo" => "Funding" ] 10 => array:2 [ "identificador" => "sec0075" "titulo" => "Conflicts of interest" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2018-07-10" "fechaAceptado" => "2018-09-04" "PalabrasClave" => array:1 [ "en" => array:2 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1157842" "palabras" => array:4 [ 0 => "Numerical data" 1 => "Research design" 2 => "Randomized controlled trials" 3 => "Low back pain" ] ] 1 => array:4 [ "clase" => "abr" "titulo" => "Abbreviations" "identificador" => "xpalclavsec1157843" "palabras" => array:2 [ 0 => "CONSORT" 1 => "PEDro" ] ] ] ] "tieneResumen" => true "highlights" => array:2 [ "titulo" => "Highlights" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0005" class="elsevierStylePara elsevierViewall">Low back pain trials are published in a variety of healthcare journals.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0010" class="elsevierStylePara elsevierViewall">The methodological quality of low back pain trials is moderate.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0015" class="elsevierStylePara elsevierViewall">55.5% of low back pain trials endorsed the CONSORT statement recommendations.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0020" class="elsevierStylePara elsevierViewall">Reporting guidelines should be strictly followed.</p></li></ul></p></span>" ] "resumen" => array:1 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Objective</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">To describe the main characteristics of low back pain randomized controlled trials on the Physiotherapy Evidence Database, and to rank the journals where these trials were published according to their Impact Factor.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Methods</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">This is a cross sectional study based on a collection of randomized controlled trials. A random sample of 200 low back pain trials published between 2010 and 2015 were selected from Physiotherapy Evidence Database in February 2016. We collected the following main characteristics of trials: 2015 journal Impact Factor; if the paper was published as open access; CONSORT recommendations endorsement by the journal; methodological quality and statistical reporting measured by the 0–10 items Physiotherapy Evidence Database scale. Data was analyzed descriptively.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Results</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Trials were published in journals with a mean Impact Factor of 2.5 (SD 2.5), from which 55.5% endorsed the CONSORT recommendations. The methodological quality was moderate with 5.8 points (SD 1.6). The top 3 journals according to Impact Factor were: (1) <span class="elsevierStyleItalic">British Medical Journal</span>; (2) <span class="elsevierStyleItalic">Annals of Internal Medicine</span>; and (3) <span class="elsevierStyleItalic">BMC Medicine</span>. Only 6 out of 97 journals publishing low back pain trials combined the following factors: journal Impact Factor higher than 2.0, mean trial methodological quality higher than 6.0 points, endorse CONSORT recommendations and offering papers as open access.</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Conclusion</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Clinicians interested in low back pain trials must look for a wide variety of healthcare journals. A substantial number of low back pain randomized controlled trials did not follow adequate reporting and methodological recommendations.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0010" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0015" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0020" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0025" "titulo" => "Conclusion" ] ] ] ] "multimedia" => array:4 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2140 "Ancho" => 2333 "Tamanyo" => 162205 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Flow chart of included randomized controlled trials.</p>" ] ] 1 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Mean (SD) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Number of articles (%) \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Continents</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">200 (100.0) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Europe \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">70 (35.0) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Asia \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">65 (32.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>North America \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">33 (16.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>South America \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13 (6.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Africa \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8 (4.0) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Oceania \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11 (5.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Written in English</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">198 (99.0) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Portuguese and Spanish \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (1.0) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Open access articles</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">115 (57.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Trials published in journals that endorsed CONSORT recommendations</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">111 (55.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Total PEDro score/Methodological quality (0–10)</span><a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5.8 (1.6) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n