Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain

Table 3 Demographic and baseline characteristics for the ITT population

Baseline characteristics to be reported by treatment group (ITT population)
n(%) unless otherwise specified			PME (n=)	PMI (n=)	Overall (n=)
*Background information*
Age at randomization [years, mean (SD)]
Sex [% male]
Time since amputation [months, mean (SD)]
Time since onset of PLP [months, mean (SD)]
Reason of amputation	trauma
	cardiovascular
	cancer
	other
Type of prosthesis	none
	active/myoelectric
	cosmetic
	passive
	body-powered
Daily prosthesis use [hours, mean (SD)]
Minimization factors	Level of amputation	upper limb
	Level of amputation	lower limb
	Intensity of PLP [NRS (0-10), mean(SD)]	high (> 4)
	Intensity of PLP [NRS (0-10), mean(SD)]	low (<= 4)
	Investigational site	#1
		#2
		#3
		#4
		#5
		#6
		#7
		#8
		#9
Chosen treatment frequency	once a week
	twice a week
	five times a week
*Q-PLP*
Intensity of stump pain [range, mean (SD)]
Intensity of PLS [range, mean (SD)]
Intensity of voluntary phantom movements [range, mean (SD)]
PRI at baseline range, mean (SD)]
Pain interference with sleep [range, mean (SD)]:
Pain interference with daily life activities [range, mean (SD)]:
Pain interference with work [range, mean (SD)]:
Presence of telescoping [range, mean (SD)]
Weighted Pain Distribution Index [range, mean (SD)]:
*Other questionnaires*
PDI [range, mean (SD)]:
EQ5D-5L [range, mean (SD)]:
PSEQ-2 [range, mean (SD)]:
PCS-SF [range, mean (SD)]:
PHQ-2 [range, mean (SD)]:
EXPECT-SF [range, mean (SD)]:

Abbreviations: PME phantom motor execution, PMI phantom motor imagery, PLP phantom limb pain, NRS Numeric Rate Scale, Q-PLP Questionnaire for Phantom Limb Pain, PDI Pain Disability Index, PSEQ-2 2-item Pain Self-Efficacy Questionnaire, EQ-5D-5L Euroqol-5D-5L, PCS-SF Pain Catastrophizing Scale Short Form, PHQ-2 2-item Patient Health Questionnaire, PGIC Patients’ Global Impression of Change, OAT Opinion About Treatment, HCCQ Health Care Climate Questionnaire, EXPECT-SF Expectations for Complementary and Alternative Medicine Treatments Short Form

ISSN: 1745-6215