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[This corrects the article DOI: 10.2196/46355.].
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BACKGROUND: The magnitude of placebo effects from physical and psychological 'sham' is unknown but could impact efficacy trials and treatment understanding. To quantify placebo effects, this systematic review of three-armed randomised controlled trials (RCTs) of physical and psychological interventions for pain compared outcomes in 'sham' control intervention and non-exposure arms. METHODS: RCTs with treatment, 'sham' control intervention, and non-exposure groups were included, enrolling adults with any pain. A protocol was pre-registered (PROSPERO: CRD42023413324), and twelve databases searched from 2008 to July 2023. Trial methods and blinding were analysed descriptively and risk of bias assessed. Meta-analysis of pain measures at short-, medium- and long-term was performed with random-effects models of standardised mean differences (SMD).Studies were sub-grouped according to control intervention type. RESULTS: Seventeen RCTs were included. The average short-term placebo effect was small (0.21 SMD, 0.1-0.33 95% CI, p = 0.0002, 1440 participants). It showed no heterogeneity (Tau2 = 0.1, I2 = 11%, p = 0.3), preventing meta-regression analyses of effect modifiers. However, sub-group analyses revealed larger placebo effects in manual control interventions compared to disabled devices and miscellaneous control interventions. Overall, placebo analgesia accounted for 39% of treatments' short-term effectiveness. No placebo effects were found at medium-term (7 RCTs, 381 participants) or long-term follow-up (3 RCTs, 173 participants). CONCLUSIONS: The observed placebo analgesia has mechanistic and methodological implications, though its clinical importance may be limited. Control intervention design affects placebo effects, highlighting the importance of considering methodology in RCT interpretation. Review limitations include a small number of long-term studies and sample heterogeneity. SIGNIFICANCE: This systematic review directly quantifies placebo effects from physical and psychological 'sham' control interventions and compares them to treatments' overall effectiveness. By doing so, the review enhances our understanding of placebo effects, their relative contribution in clinical trials, and their susceptibly to trial design. It poses further questions regarding the influence of blinding, participant expectations, and features of the therapeutic context. Overall, the insights provided by this review carry methodological significance and are important for the interpretation and synthesis of efficacy trials in this field.
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Analgesia , Adulto , Humanos , DolorRESUMEN
BACKGROUND: The COVID-19 pandemic forced numerous touch-based fields, including manual therapy, body psychotherapy, arts therapy, creative arts practices, and the fitness industry, to swiftly transition to web-based service delivery. These disciplines faced substantial challenges in adapting their traditionally in-person practices, which rely heavily on physical touch and close proximity, to a web format. OBJECTIVE: This review intends to provide a systematically sourced overview of the literature concerning innovative approaches for adapting touch-based practices to the web format in response to the COVID-19 pandemic. METHODS: A systematic search across 7 databases and gray literature sources identified studies presenting innovative web delivery methods, particularly those addressing the challenges arising from the absence of physical proximity and touch. The inclusion criteria were designed to encompass studies exploring the creative adaptation of touch-based practices to web formats in response to the COVID-19 pandemic irrespective of study methodology. The exclusion criteria applied to studies focusing solely on technical aspects of web delivery or nontouch or noninteractive practices. There were no geographical restrictions, but the selection was limited to publications from 2020 onward. As only qualitative studies were found, data synthesis was conducted thematically. RESULTS: The review encompassed 17 studies revealing that touch-based fields successfully devised innovative and creative methods for web service delivery. These methods were categorized into five main themes: (1) adapted working methods (cross-field methods), (2) adapted working methods for sensorial experiences and nonphysical connections, (3) creative methods using materials or additional tools, (4) creative use of web-based platform tools or additional technologies, and (5) creative methods requiring previous preparation of practitioners or participants. These creative approaches allowed practitioners to address the challenges of web touch-based practices, fostering connections and offering unique sensory experiences, albeit with some concerns related to technology and preparation. CONCLUSIONS: These innovative methods demonstrate promise in circumventing the limitations imposed by the lack of physical touch and proximity in web settings during the COVID-19 pandemic. Furthermore, these insights hold potential for application in other fields in the future. This systematic search and thematic synthesis provide valuable guidance for practitioners and educators seeking to navigate the evolving landscape of web service delivery in touch-based disciplines, ensuring continuity of care even in challenging circumstances. TRIAL REGISTRATION: PROSPERO CRD42022379731; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=379731.