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      Effectiveness of in-group versus individually administered pain neuroscience education on clinical and psychosocial outcomes in patients with chronic low back pain: randomized controlled study protocol

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          Abstract

          Objective

          (1) This trial will compare the clinical and psychosocial effectiveness of in-group and individually pain neuroscience education (PNE) in patients with chronic low back pain (CLBP). In addition, (2) the influence of social determinants of health on post-treatment results will be analyzed.

          Methods

          A three-arm randomized controlled trial will be conducted. Sixty-nine participants with CLBP will be recruited in a 1:1:1 ratio. Participants, assessor, and statistician will be blinded to group assignment. The PNE intervention will be adapted to the context of the participants. An experimental group ( n = 33) will receive PNE in an in-group modality, the other experimental group ( n = 33) will receive PNE in an individually modality and the control group ( n = 33) will continue with usual care. Additionally, participants will be encouraged to stay active by walking for 20–30 min 3–5 times per week and will be taught an exercise to improve transversus abdominis activation (bracing or abdominal following). The outcome measures will be fear avoidance and beliefs, pressure pain threshold, pain self-efficacy, catastrophizing, pain intensity, and treatment expectation. Outcome measures will be collected at one-week before intervention, immediately post-intervention, and four-weeks post-intervention.

          Conclusion

          The innovative approach of PNE oriented to fear beliefs proposed in this study could broaden the application strategies of this educational therapeutic modality. Impact. Contextualized PNE delivered by physical therapist could be essential to achieve a good cost-effectiveness ratio of this intervention to improve the clinical condition of people with CLBP.

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          Most cited references72

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          A power primer.

          One possible reason for the continued neglect of statistical power analysis in research in the behavioral sciences is the inaccessibility of or difficulty with the standard material. A convenient, although not comprehensive, presentation of required sample sizes is provided here. Effect-size indexes and conventional values for these are given for operationally defined small, medium, and large effects. The sample sizes necessary for .80 power to detect effects at these levels are tabled for eight standard statistical tests: (a) the difference between independent means, (b) the significance of a product-moment correlation, (c) the difference between independent rs, (d) the sign test, (e) the difference between independent proportions, (f) chi-square tests for goodness of fit and contingency tables, (g) one-way analysis of variance, and (h) the significance of a multiple or multiple partial correlation.
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            Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

            Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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              SPIRIT 2013 statement: defining standard protocol items for clinical trials.

              The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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                Author and article information

                Contributors
                Journal
                PeerJ
                PeerJ
                peerj
                PeerJ
                PeerJ Inc. (San Diego, USA )
                2167-8359
                31 May 2024
                2024
                : 12
                : e17507
                Affiliations
                [1 ]Laboratorio de Investigación Somatosensorial y Motora, Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás , Talca, Chile
                [2 ]Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás , Talca, Chile
                [3 ]Departamento de Procesos Terapéuticos, Facultad de Ciencias de la Salud, Universidad Católica de Temuco , Temuco, Chile
                [4 ]Facultad de Ciencias de la Salud, Universidad Autónoma de Chile , Temuco, Chile
                [5 ]Facultad de Ciencias, Escuela de Kinesiología, Universidad Mayor , Temuco, Chile
                [6 ]Departament of Physical Therapy, Faculty of Medicine, University of Chile , Santiago, Chile
                [7 ]Clinical Research Lab, Department of Physical Therapy, Catholic University of Maule , Talca, Chile
                [8 ]Faculty of Rehab Medicine, University of Alberta , Edmonton, Canada
                Article
                17507
                10.7717/peerj.17507
                11146333
                38832030
                41bb13ad-a0f9-4ab1-8207-9c00470dc690
                ©2024 Salazar-Méndez et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. For attribution, the original author(s), title, publication source (PeerJ) and either DOI or URL of the article must be cited.

                History
                : 20 March 2024
                : 13 May 2024
                Funding
                The authors received no funding for this work.
                Categories
                Neuroscience
                Kinesiology

                chronic pain,neuroscience,musculoskeletal pain,pain neuroscience education,low back pain,clinical trial protocol

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