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Table 8 Summary of the outcome assessment schedule

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

Session

Summary of content

Visit 0

• Patient information (T/E)

• Study consent (T/E)

• Pre-assessment (T/E)

• Background information (T/E)

• Q-PLP (T/E)

• PDI (T/E)

• EQ-5D-5L (T/E)

• PSEQ-2 (T/E)

• PCS-SF (T/E)

• PHQ-2 (T/E)

• EXPECT-SF (T/E)

Randomization

Visit 1

• Treatment session (T)

• Q-PLP (E)

• OAT (E)

• EXPECT-SF (E)

• HCCQ-SF (E)

Visit 2–14

• Treatment session (T)

• Q-PLP (E)

Visit 15

• Treatment session (T)

• Q-PLP (E)

• PDI (E)

• EQ-5D-5L (E)

• PSEQ-2 (E)

• PCS-SF (E)

• PHQ-2 (E)

• PGIC (E)

• HCCQ-SF (E)

1-month follow-up

• Q-PLP (E)

• PDI (E)

• EQ-5D-5L (E)

• PSEQ-2 (E)

• PCS-SF (E)

• PHQ-2 (E)

3-month follow-up

6-month follow-up

  1. Abbreviations: 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