Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods.

Autor:	Hohenschurz-Schmidt D; Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College, Chelsea, London, United Kingdom., Draper-Rodi J; Research Centre, University College of Osteopathy, London, United Kingdom., Vase L; Section for Psychology and Neuroscience, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus C, Denmark., Scott W; Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.; INPUT Pain Management Unit, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom., McGregor A; Human Performance Group, Department of Surgery and Cancer, Faculty of Medicine, Imperial College, London, United Kingdom., Soliman N; Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College, Chelsea, London, United Kingdom., MacMillan A; Research Centre, University College of Osteopathy, London, United Kingdom., Olivier A; Faculty of Medicine, Imperial College London, London, United Kingdom., Cherian CA; Chemical Engineering Department, Khalifa University, Abu Dhabi, United Arab Emirates., Corcoran D; West Ballina, Australia., Abbey H; Research Centre, University College of Osteopathy, London, United Kingdom., Freigang S; Department of Neurosurgery, Medical University Graz, Graz, Austria., Chan J; Faculty of Medicine, Imperial College London, London, United Kingdom., Phalip J; Résidence les Estrangers, La Bourboule, France., Nørgaard Sørensen L; Department of Occupational Medicine, Danish Ramazzini Centre, Aarhus University Hospital, Aarhus, Denmark., Delafin M; The Penn Clinic, Hertfordshire, Hatfield, United Kingdom., Baptista M; Department of Psychology, Wolfson Centre for Age Related Diseases, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom., Medforth NR; London, United Kingdom., Ruffini N; National Centre Germany, Foundation C.O.M.E. Collaboration, Berlin, Germany., Skøtt Andresen S; Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus C, Denmark., Ytier S; Vevey, Switzerland., Ali D; Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom., Hobday H; Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom., Santosa AANAA; Denpasar, Indonesia., Vollert J; Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College, Chelsea, London, United Kingdom.; Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital of Schleswig-Holstein, Kiel, Germany.; Neurophysiology, Mannheim Center of Translational Neuroscience (MCTN), Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.; Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany., Rice ASC; Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College, Chelsea, London, United Kingdom.
Jazyk:	angličtina
Zdroj:	Pain [Pain] 2023 Mar 01; Vol. 164 (3), pp. 469-484. Date of Electronic Publication: 2022 Jul 11.
DOI:	10.1097/j.pain.0000000000002723
Abstrakt:	Abstract: Blinding is challenging in randomised controlled trials of physical, psychological, and self-management therapies for pain, mainly because of their complex and participatory nature. To develop standards for the design, implementation, and reporting of control interventions in efficacy and mechanistic trials, a systematic overview of currently used sham interventions and other blinding methods was required. Twelve databases were searched for placebo or sham-controlled randomised clinical trials of physical, psychological, and self-management treatments in a clinical pain population. Screening and data extraction were performed in duplicate, and trial features, description of control methods, and their similarity to the active intervention under investigation were extracted (protocol registration ID: CRD42020206590). The review included 198 unique control interventions, published between 2008 and December 2021. Most trials studied people with chronic pain, and more than half were manual therapy trials. The described control interventions ranged from clearly modelled based on the active treatment to largely dissimilar control interventions. Similarity between control and active interventions was more frequent for certain aspects (eg, duration and frequency of treatments) than others (eg, physical treatment procedures and patient sensory experiences). We also provide an overview of additional, potentially useful methods to enhance blinding, as well as the reporting of processes involved in developing control interventions. A comprehensive picture of prevalent blinding methods is provided, including a detailed assessment of the resemblance between active and control interventions. These findings can inform future developments of control interventions in efficacy and mechanistic trials and best-practice recommendations. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)
Databáze:	MEDLINE
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