Pain reduction by inducing sensory-motor adaptation in Complex Regional Pain Syndrome (CRPS PRISMA): protocol for a double-blind randomized controlled trial

Halicka, Monika; Vittersø, Axel D.; Proulx, Michael J.; Bultitude, Janet H.

doi:10.1186/s12883-020-1604-z

Table 3 Measures

From: Pain reduction by inducing sensory-motor adaptation in Complex Regional Pain Syndrome (CRPS PRISMA): protocol for a double-blind randomized controlled trial

Measurement domain	Measurement tool	Time points	Research question^a/justification for use
Self-report measures
Pain and symptom interference	Current pain intensity (Item 6 of the Brief Pain Inventory)	Weeks 1, 4, 7, 11, 19 & 31	RQ1, RQ3, RQ4, RQ5; group matching on baseline pain
	Brief Pain Inventory^b (BPI; short form; pain intensity and interference) [42]		RQ2, RQ3, RQ4, RQ5
	Pain Detect Questionnaire [43]		RQ2, RQ3, RQ4, RQ5
	Average pain intensity (Logbook)	Weeks 1 to 11 (daily)	RQ2, RQ3
	Average symptom interference (Logbook)	Weeks 1 to 11 (daily)	RQ2, RQ3
Physical functioning	Average range of movement (Logbook)	Weeks 1 to 11 (daily)	RQ2, RQ3
Physical functioning	Edinburgh Handedness Inventory (current and change) [44]	Week 1	RQ4, RQ5; participant characteristics
Body representation	Bath CRPS Body Perception Disturbance Scale (BPDS) [45]	Weeks 1, 4, 7, 11, 19 & 31	RQ2, RQ3, RQ4, RQ5
Emotional functioning	Tampa Scale for Kinesiophobia^b [46]	Weeks 1, 4, 7, 11, 19 & 31	RQ2, RQ3, RQ4, RQ5; group matching on baseline fear of movement
	Profile of Mood States [47]	Weeks 1, 4, 7, 11, 19 & 31	RQ2, RQ3, RQ4, RQ5; group matching on baseline mood disturbance
	Revised Life Orientation Test [48]	Week 1	RQ4; group matching on baseline levels of optimism
Treatment expectations	Patient-Centred Outcomes Questionnaire [49]	Week 1	RQ4; group matching on expectations of treatment outcomes
Impression of treatment outcome	Patient’s Global Impression of Change [50]	Weeks 7, 11, 19 & 31	RQ2, RQ3
Treatment adherence	Treatment sessions (Logbook)	Weeks 4 to 6 (twice-daily)	Monitoring treatment adherence
Clinical assessments
CRPS diagnosis	Budapest diagnostic research criteria assessment [51]	Weeks 1, 4, 7 & 11	Verification of CRPS diagnosis and assessment of eligibility
Symptom severity	CRPS severity score [52]	Weeks 1, 4, 7 & 11	RQ1, RQ3, RQ4, RQ5; group matching on baseline symptom severity
Autonomic functions	Limb temperature asymmetry	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5
Autonomic functions	Oedema	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5
Motor functions	Grip strength	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5
Motor functions	Δ Finger-To-Palm distance (ΔFTP)	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5
Sensory functions	Mechanical Detection Threshold (MDT)	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5
	Mechanical Pain Threshold (MPT)
	Mechanical Allodynia
	Two-Point Discrimination [53]
Computer-based tests of neuropsychological changes
Visuospatial attention	Visual Temporal Order Judgement (TOJ) task [8]	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5
	Landmark task [54]
	Greyscales task [55]
Mental representation of space	Mental Number Line Bisection task [56]	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5
Spatially-defined motor function	Directional Hypokinesia task [57]	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5
Body representation	Hand Laterality Recognition task [58]	Weeks 1, 4, 7 & 11	RQ2, RQ3, RQ4, RQ5

^aRQ1, effects of treatment on the primary outcome measures; RQ2, effects of treatment on the secondary outcome measures; RQ3, time course / duration of any changes; RQ4, predictors of CRPS progression over time and/or response to treatment; RQ5, baseline abnormalities in neuropsychological functions in participants with CRPS compared to pain-free controls, and their relationships with clinical signs of CRPS (only Week 1 data)
^bBrief Pain Inventory interference subscale and Tampa Scale for Kinesiophobia are also considered proxy measures of physical functioning

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ISSN: 1471-2377

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