Biomarkers for Prediction of Analgesic Efficacy in Knee OA.
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
With high NNTs for indiscriminative use in chronic pain, treatment unavoidably entails
frustrating long trial and errors. It is timely to identify biomarkers that can predict
analgesic efficacy for the individual patient.
The investigators propose a framework of interrelations between patient's pain modulation
profile (PMP) and the drug's mode of action (MOA) based on two principles: (1) 'fix the
dysfunction', relevant for drugs whose main mode of action is to modulate central pain
processing; the more the dysfunctional the better the modulating drug efficacy. For example,
patients with pro-nociceptive PMP due to reduced endogenous pain inhibition, as expressed by
less efficient CPM will benefit from drugs that fix this dysfunction such as SNRIs, relative
to patients whose pain inhibitory capacity is well functioning. Thus, for the modulating
drugs, pro-nociceptivity predicts better efficacy. (2) 'bear with the dysfunction', relevant
for drugs which are mostly non-modulating, acting mainly in the periphery; the more
dysfunctionalת the less the non-modulating drug efficacy. This is since efficacy is limited
by the dysfunctional modulation system, despite the drug's MOA-like reduction of peripheral
pain mediators. Thus, for the non-modulating drugs, for example NSAIDs, pro-nociceptivity
predicts less good efficacy. The likely protocol suggests that patients with anti-nociceptive
PMP should be treated primarily by non-modulating drugs, while pro-nociceptive ones should be
given modulating drugs.
EEG is an additional source of relevant data on brain pain processing. Being objective and
stable along time, EEG based parameters are, thus, very attractive candidates to be useful
biomarkers for prediction of analgesia efficacy.
This study will focus on the patients with painful knee osteoarthritis.
The aims of this study are:
1. To identify psychophysical and neurophysiological biomarkers that can serve as
predictors of response to analgesic pain modulating and non-pain modulating drugs.
2. To establish a conceptual framework of individualized pain therapy based on
inter-relations between patient's parameters of pain modulation and drugs' mode of
action.