The importance of using placebo controls in nonpharmacological randomised trials

Wartolowska, Karolina; Hohenschurz-Schmidt, David; Vase, Lene; Aronson, Jeffrey K

doi:10.1097/j.pain.0000000000002839

Cited by 3 publications

(2 citation statements)

References 44 publications

(62 reference statements)

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“…Specific to pain as an outcome, this assumption neglects the potential analgesic response to a placebo [ 145 , 146 ]. Consequently, a studied intervention providing no greater pain relief than a placebo comparator may suggest two equally effective interventions, potentially with differing mechanisms behind their effectiveness [ 167 ]. Different factors need to be considered for designing and interpreting placebo-controlled studies on interventions for pain [ 145 , 146 ].…”

Section: Future Directions For Research and Clinical Trialsmentioning

confidence: 99%

The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art

Rossettini,

Campaci,

Bialosky

et al. 2023

JCM

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(1) Background: In recent years, placebo and nocebo effects have been extensively documented in different medical conditions, including pain. The scientific literature has provided strong evidence of how the psychosocial context accompanying the treatment administration can influence the therapeutic outcome positively (placebo effects) or negatively (nocebo effects). (2) Methods: This state-of-the-art paper aims to provide an updated overview of placebo and nocebo effects on pain. (3) Results: The most common study designs, the psychological mechanisms, and neurobiological/genetic determinants of these phenomena are discussed, focusing on the differences between positive and negative context effects on pain in experimental settings on healthy volunteers and in clinical settings on chronic pain patients. Finally, the last section describes the implications for clinical and research practice to maximize the medical and scientific routine and correctly interpret the results of research studies on placebo and nocebo effects. (4) Conclusions: While studies on healthy participants seem consistent and provide a clear picture of how the brain reacts to the context, there are no unique results of the occurrence and magnitude of placebo and nocebo effects in chronic pain patients, mainly due to the heterogeneity of pain. This opens up the need for future studies on the topic.

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Section: Future Directions For Research and Clinical Trialsmentioning

confidence: 99%

The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art

Rossettini,

Campaci,

Bialosky

et al. 2023

JCM

Self Cite

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show abstract

“…Taken together, these findings may discourage the search for a placebo comparator, considering it more of a chimaera than a need. However, the placebo control group is essential in non-pharmacological RCTs (e.g., in manual therapy) to inform patients, clinicians, and policy-makers about the efficacy and risks of interventions [21]. Therefore, we call to action researchers in manual therapy to improve the reporting of their trials by providing more details on placebo control (e.g., procedure, dose), controlling for nonspecific elements (e.g., expectation, rituals), and ensuring the indistinguishability of the technique (e.g., comparing real manual techniques with sham techniques and not with other modalities).…”

mentioning

confidence: 99%

“Do Not Mix Apples with Oranges” to Avoid Misinterpretation of Placebo Effects in Manual Therapy: The Risk Is Resulting in a Fruit Basket. Comment on Molina-Àlvarez et al. Manual Therapy Effect in Placebo-Controlled Trials: A Systematic Review and Meta-Analysis. Int. J. Environ. Res. Public Health 2022, 19, 14021

Rossettini

Pellicciari

Turolla

2023

IJERPH

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Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

Hohenschurz-Schmidt,

Cherkin,

Rice

et al. 2024

Pain

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Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

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The importance of using placebo controls in nonpharmacological randomised trials

Cited by 3 publications

References 44 publications

The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art

The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art

Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

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