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Table 1 Study parameter table

From: Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial

Assessments

Pre-treatment

1 month from randomization

Follow-up: At 3, 6, 12, 24 months from randomization

History/physical

Within 2 weeks prior to registration

 

X

Performance status

Baseline

 

X

Neurological exam

Within 1 week prior to registration

 

X

Imaging of the spine (CT scan/bone scan is allowed, MRI preferred)

Within 6 weeks prior to registration

 

X

Numerical rating pain scale and documentation of patient’s pain medicationa

Within 1 week prior to registration

(On the day of treatment)

(At home: Daily with cumulative weekly measurements at 1, 2, and 3 weeks; bring to clinic at 1 month)

In clinic at 1 month

X

FACT-G (FA), BPI (QL), EQ-5D (HP)

Baseline

 

At 3, 6, 12, and 24 months from randomization

Adverse event evaluation

 

X

X

  1. aNRPS at 3 months is required for analysis of the primary endpoint