Five challenges for manual therapies trials with placebo controls: A proposal

IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL International Journal of Osteopathic Medicine Pub Date : 2022-12-01 DOI:10.1016/j.ijosm.2022.08.002
Giandomenico D'Alessandro , Nuria Ruffini , Alessio Iacopini , Marco Annoni , Joe Kossowsky , Francesco Cerritelli
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Abstract

Randomised placebo-controlled trials (RCT) are implemented to determine whether a particular therapy is superior to placebo and can thus be considered effective. However, adopting the standard RCT design in contexts other than pharmacological trials, such as manual therapy, may result in systematic biases. These biases may occur due to: the impossibility of traditional “double-blinding” in manual therapy trials; insufficient pre-training of operators delivering the treatment and/or sham therapy; biased recruitment of study participants; the problematic use of subjective and/or objective outcomes; and finally, the presence of phenomena mimicking placebo effects. From the perspective of placebo studies, the purpose of this paper is to discuss and make appropriate recommendations to address these five issues in manual therapy research.

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安慰剂对照手工疗法试验的五大挑战:建议
实施随机安慰剂对照试验(RCT)以确定特定疗法是否优于安慰剂,从而被认为是有效的。然而,在药理学试验以外的环境中采用标准的随机对照试验设计,如手工治疗,可能会导致系统偏差。这些偏倚的发生可能是由于:在手工治疗试验中不可能采用传统的“双盲”;对提供治疗和/或虚假治疗的操作人员的预先培训不足;有偏见地招募研究参与者;有问题地使用主观和/或客观结果;最后,出现了模仿安慰剂效应的现象。本文旨在从安慰剂研究的角度出发,对手工疗法研究中存在的这五个问题进行探讨,并提出相应的建议。
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来源期刊
CiteScore
2.20
自引率
36.80%
发文量
42
审稿时长
3 months
期刊介绍: The International Journal of Osteopathic Medicine is a peer-reviewed journal that provides for the publication of high quality research articles and review papers that are as broad as the many disciplines that influence and underpin the principles and practice of osteopathic medicine. Particular emphasis is given to basic science research, clinical epidemiology and health social science in relation to osteopathy and neuromusculoskeletal medicine. The Editorial Board encourages submission of articles based on both quantitative and qualitative research designs. The Editorial Board also aims to provide a forum for discourse and debate on any aspect of osteopathy and neuromusculoskeletal medicine with the aim of critically evaluating existing practices in regard to the diagnosis, treatment and management of patients with neuromusculoskeletal disorders and somatic dysfunction. All manuscripts submitted to the IJOM are subject to a blinded review process. The categories currently available for publication include reports of original research, review papers, commentaries and articles related to clinical practice, including case reports. Further details can be found in the IJOM Instructions for Authors. Manuscripts are accepted for publication with the understanding that no substantial part has been, or will be published elsewhere.
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