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

David Hohenschurz-Schmidt*, Jerry Draper- Rodi, Lene Vase, Whitney Scott, Alison McGregor, Nadia Soliman, Andrew MacMillan, Axel Olivier, Cybill Ann Cherian, Daniel Corcoran, Hilary Abbey, Sascha Freigang, Jessica Chan, Jules Phalip, Lea Nørgaard Sørensen, Maite Delafin, Margarida Cadete Pedro Dos Santos Baptista, Naomi R Medforth, Nuria Ruffini, Stephanie Skøtt Andresen Skøtt AndresenSylvain Ytier, Dorota Ali, Harriet Hobday, Anak Agung Ngurah Agung Adhiyoga Santosa, Jan Vollert, Andrew SC Rice

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

16 Citations (Scopus)
46 Downloads (Pure)

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.

Original languageEnglish
Pages (from-to)469-484
Number of pages16
JournalPain
Volume164
Issue number3
Early online date11 Jul 2022
DOIs
Publication statusPublished - 1 Mar 2023

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