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