Table 2

Analysis of change from baseline to month 6 in the average AS score in the LE (primary outcome) and UE (secondary outcome)

Change from baseline to month 6*P value†Hodges-Lehmann estimate‡
ITB (n=31)CMM (n=29)
Average AS score in the LE of the affected side
ITTN25260.0140−0.667 (95.1%CI −1.0000 to −0.1667)
Mean (SD)−0.99 (0.75)−0.43 (0.72)
Median (min, max)−0.83 (−2.3, 0.7)−0.25 (−2.2, 0.7)
Per protocolN15200.0592−0.667 (95.1%CI −1.1667 to  0.0000)
Mean (SD)−1.09 (0.63)−0.48 (0.82)
Median (min, max)−0.83 (−2.3, 0.0)−0.42 (−2.2, 0.7)
Modified ITTN22290.0019−0.667 (95.1%CI −1.1667 to −0.3333)
Mean (SD)−1.11 (0.68)−0.39 (0.71)
Median (min, max)−0.92 (−2.3, 0.3)−0.33 (−2.2, 0.7)
ITT
completers
N24240.0240−0.667 (95.1%CI −1.0000 to −0.1667)
Mean (SD)−1.01 (0.75)−0.47 (0.73)
Median (min, max)−0.83 (−2.3, 0.7)−0.33 (−2.2, 0.7)
Average AS score in the UE of the affected side
ITTN25260.0042−0.600 (95%CI−1.0000 to  −0.2000)
Mean (SD)−0.66 (0.59)−0.17 (0.70)
Median (min, max)−0.60 (−1.6, 0.6)0.00 (−2.4, 0.6)
Per protocolN15200.0494−0.600 (95%CI −1.0000 to 0.0000)
Mean (SD)−0.64 (0.58)−0.22 (0.78)
Median (min, max)−0.60 (−1.4, 0.6)0.00 (−2.4, 0.6)
  • *For the ITT and modified-ITT populations, the calculation was based on LOCF imputation using data for month 3 assessment in patients for whom month 6 data were not available. Patients with data missing for both months 3 and 6 were excluded from the analysis.

  • †Wilcoxon Rank Sum test: comparison of the difference in the change of AS score from baseline to month 6 between groups.

  • ‡Hodges-Lehmann estimate of the location shift (asymptotic method) between groups with 95.1% CI for average AS score in the LE and 95% CI for average AS score in the UE.

  • AS, Ashworth Scale; CMM, conventional medical management; ITB, intrathecal baclofen; ITT, intention-to-treat; LE, lower extremities; LOCF, last observation carried forward; UE, upper extremities.