The ACTTION Guide to Clinical Trials of Pain Treatments: standing on the shoulders of giants

The biopsychosocial model of pain 40 years on: time for a reappraisal?

“…This has been a recurring challenge for the field, 99 but the realisation that interventions increasingly require multiple inputs from several domains and cannot be easily evaluated in RCT formats is still to gain real traction. Many possible options have been proposed, 31,63,75,101,146,152 and they include the use of methods such as single-case design studies, pragmatic trials, and stepped wedge designs that are more feasible in clinical settings (see Keefe et al 75 for a recent review). Identifying "which treatments for which patients" remains a challenge in the pain field, 146,151 and from a biopsychosocial perspective, we might add, "under which conditions."…”

“…Despite these debates and concerns over the last 201 years, many recent publications 21,31,137 have continued to endorse the relevance of the biopsychosocial model of pain in explaining and treating pain. At a minimum, this suggests the model has commendable resilience, even if its impact on treatment contents and outcomes is unclear.…”

Clinical Trials in Pancreatitis: Opportunities and Challenges in the Design and Conduct of Patient-Focused Clinical Trials in Recurrent Acute and Chronic Pancreatitis

“…To address challenges in the design, conduct, and analysis of pain clinical trials, various factors should be considered. [24][25][26][27][28][29][30] These include increased attention to (1) patient selection and training; (2) adequate blinding of participants, investigators, and outcome assessors; (3) mitigation of treatment nonadherence; (4) prespecification of outcomes, analyses, and accommodation of intercurrent events and missing data; (5) reducing placebo group responses by minimizing placebo effects and participant expectations to the greatest extent possible; (6) distinguishing clinically meaningful within-participant improvements from clinically meaningful group differences in clinical trials; (7) engaging patient partners throughout all stages of developing pain treatments; and (8) analyzing heterogeneity of treatment effects, a crucial basis for the development of precision pain treatments. An evidencebased approach to the design of clinical trials, especially when involving pain treatments, has the potential to increase assay sensitivity (ie, the ability to detect a true benefit when present) and informativeness, thereby accelerating the availability of novel treatments for patients with painful RAP or CP.…”

The importance of using placebo controls in nonpharmacological randomised trials

“…Efficacy trials are challenging because of requirements for standardisation and minimisation of bias. 11 This is even more of a problem for nonpharmacological trials because the equivalent of a dummy pill does not exist, identifying the key therapeutic element may be difficult, and standardising the test and control procedures is often challenging. 22 This is further complicated by the cointerventions, which have to be standardised and potentially matched between the arms.…”