Intermittent versus continuous esketamine infusions for long-term pain modulation in complex regional pain syndrome: protocol of a randomized controlled non-inferiority study (KetCRPS-2)

Table 1 Overview of schedule of enrolment, interventions and assessments in the KetCRPS-2 study. According to Standard Protocol Items Recommendations for International Trials (SPIRIT) [17, 18]

TIMEPOINT	STUDY PERIOD
	Enrolment	Allocation	Post-allocation				Close-out
	-t₂	-t₁	T0	*T1A-F*	*T2A-F*	T3	T4
ENROLMENT
Eligibility screen	X
Informed consent	X
Allocation		X
INTERVENTIONS
*Esketamine infusion*				X
ASSESSMENTS
*Medical history*	X		X			X	X
*NRS pain scores*			X	X	X	X	X
*CRPS severity score* [14]			X			X
*COMPACT questionnaire(s)* [19]			X		X^a	X^c	X^a
*Quantitative sensory testing*			X			X
*Conditioned pain stimulation*			X			X
*Thermography*			X			X
*Blood samples*			X	X^b		X

Abbreviations: NRS Numerical Rating Scale, GPE Global Perceived Effect, COMPACT the Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies
^aOnly the Global Perceived Effect [20] and/or the EQ-5D-5L [21]
^bLiver enzymes are assessed to detect hepatotoxicity (standard care)
^cQST features temporal summation and pressure algometry

ISSN: 1471-2474