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Table 2 Secondary outcome parameters.

From: Intravenous immunoglobulin in the treatment of primary trigeminal neuralgia refractory to carbamazepine: a study protocol[ISRCTN33042138]

Variable Groups compared Scale Time period of evaluation Time compared with
Improvement A PGIC α Week preceding treatment
Reduction in carbamazepine A Fraction of patients with a reduction of dose; absolute reduction of dose α As above
Pain A 11-point numeric rating scale α As above
Pain A Categorical verbal pain scale α As above
Pain A Average number of attacks α As above
Number of patients to cross over A Fraction of patients enrolled in crossover period At crossover -
Time in study B Number of days Crossover period Main study period
Improvement B PGIC α Same time periods post crossover, as judged against the week preceding treatment.
Pain B 11-point numeric rating scale α Same time periods post crossover
Pain B Categorical verbal pain scale α As above
Pain B Average number of paroxysms α As above
Quality of life A COOP/WONCA charts, SF-36 β -
Quality of life B PACIS, COOP/WONCA charts, SF-36 β PACIS: immediately before first treatment
  1. A: Patients with placebo and patients with IVIG, B: Patients post crossover and same patients before crossover, α: Average of values from study day 13–19 and average of values during 7 days before termination/ completion of study, β: First two weeks following (main or crossover) treatment and last two weeks before the end of (main or crossover) study for a particular patient, PACIS: one time point measurement at day 14 following treatment and at the day of the end of (main or crossover) study. PGIC: Patient Global Impression of Change Scale [17]; SF-36: Medical Outcomes Study 36-Item Short Form [18]; COOP/WONCA: Dartmouth Primary Care Cooperative Information Project charts for adults [19]; PACIS: Perceived Adjustment to Chronic Illness Scale [20].