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Table 3 Demographic and baseline characteristics for the ITT population

From: 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

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    
Type of prosthesis none    
Daily prosthesis use [hours, mean (SD)]    
Minimization factors Level of amputation upper limb    
lower limb    
Intensity of PLP [NRS (0-10), mean(SD)] high (> 4)    
low (<= 4)    
Investigational site #1    
Chosen treatment frequency once a week    
twice a week    
five times a week    
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)]:    
  1. 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