Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations

Poderia a atividade física induzir analgesia em pacientes com dor crônica?

“…Aproximadamente, 47% dos pacientes com fibromialgia (síndrome de dor crônica difusa) não aderem à medicação prescrita, seja intencionalmente ou pela intensidade dos efeitos colaterais da medicação (12) . O tratamento da dor crônica caracteriza-se por programas multidimensionais agindo sobre características biopsicossociais (10,13) . No plano biológico esses programas visam regular os mecanismos endógenos de controle da dor e a concentração de neurotransmissores (como serotonina, noradrenalina e dopamina).…”

“…O tratamento clássico da dor (aguda) consiste em repouso e uso de fármacos para o alívio do sintoma, para favorecer a cicatrização da lesão (8) e a redução do processo inflamatório (9) . Ao contrário do tratamento da dor aguda, os agentes químicos analgésicos não se demonstram eficazes contra a dor crônica (10,11) . A baixa eficácia do uso contínuo de fármacos está inevitavelmente associada a efeitos secundários indesejáveis e à baixa adesão ao tratamento farmacológico.…”

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

“…IMMPACT was conceptualized as a series of meetings involving industry, academia and the FDA to "develop consensus reviews and recommendations for improving the design, execution and interpretation of clinical trials for pain" (IMMPACT, 2002). IMMPACT has published recommendations on patient-reported outcomes (Turk et al, 2006), assay sensitivity (Dworkin et al, 2012), abuse-deterrence (Dworkin et al, 2012), multiple endpoints and missing data analysis (Turk et al, 2008a;Gewandter et al, 2014b), disclosure of authorship contributions (Hunsinger et al, 2014) and interpretive "spin" (Gewandter et al, 2015). Together, these articles argue for the necessity of widely agreedupon standard forms of recording and reporting data from clinical trials, as well as on alternative design strategies such as enrichment.…”

“…Researchers remain dependent on subjective patient self-reporting for pain measurement and even standardized methods for the clinical evaluation of pain rely on patient-reported numerical variables, facial expression scales or qualitative descriptions that range from "no pain at all" to "worst pain imaginable" (Hewitt et al, 2011). A significant portion of IMMPACT's and ACTTION's publications have been devoted to rationalizing and standardizing measurement, rating scales and outcomes in pain trials (Turk et al, 2003;Dworkin et al, 2005b;Turk et al, 2006;Farrar et al, 2014;Fillingim et al, 2014;Smith et al, 2015). Even as the burgeoning sciences of biomarkers and genomics have invigorated the search for a mechanism-based understanding of chronic pain (Kim et al, 2009;Diatchenko et al, 2013), pain scientists recognize that the fruits of such inquiry will still need to be coordinated with, rather than superordinate to, environmental and psychosocial aspects of the pain experience (Borsook and Kalso, 2013;Fillingim et al, 2014).…”

Recommandations sur la prise en charge de l’arthrose de la hanche et du genou. Pour qui ? Pourquoi ? Pour quoi faire ?

“…Dans ce type de pathologie chronique, l'effet propre du placebo est déjà ressenti par le patient lui-même comme « cliniquement pertinent » (amélioration de 20 %, 30 % parfois 50 % de son niveau de douleur initial). Dès lors, pour un traitement, l'objectif n'est plus d'obtenir une différence importante par rapport à l'effet placebo, mais simplement une différence [10,11]. Les recommandations sont établies à un temps donné.…”