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Table 2 Mean changes in secondary endpoints from baseline to follow-up visits (Per-protocol Set)

From: Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study

   HMWHA XLHA P-value
N = 111 N = 97
WOMAC
Pain subscore Visit 5 −3.2 (3.15) −2.77 (3.28) 0.51B
  Visit 6 −3.87 (3.53) −3.39 (3.64) 0.54B
  Visit 7 −4.23 (3.7) −3.96 (3.37) 0.59A
Function subscore Visit 5 −8.05 (9.73) −7.89 (10.23) 0.91A
  Visit 6 −11.03 (11.84) −10.74 (10.84) 0.86A
  Visit 7 −12.09 (12.47) −12.57 (9.58) 0.76A
Stiffness subscore Visit 5 −0.99 (1.67) −0.88 (1.6) 0.58B
  Visit 6 −1.21 (1.72) −1.18 (1.59) 0.94B
  Visit 7 −1.34 (1.84) −1.25 (1.59) 0.75B
Total score Visit 5 −12.18 (13.56) −11.54 (13.93) 0.74A
  Visit 6 −16.02 (16.04) −15.31 (15) 0.74A
  Visit 7 −17.57 (17.21) −17.77 (13.47) 0.92A
Patient’s global assessment
  Visit 5 −15.11 (18.22) −17.51 (23.72) 0.91B
  Visit 6 −23.15 (21.88) −24.64 (22.55) 0.86B
  Visit 7 −26.91 (24.34) −30.1 (21.75) 0.32A
Investigator’s global assessment
  Visit 5 −21.86 (20.07) −21.1 (22.08) 0.71B
  Visit 6 −27.66 (19.75) −28.24 (23.44) 0.93B
  Visit 7 −33.23 (20.92) −32.52 (22.89) 0.82A
100 mm VAS on pain
Rest pain Visit 5 −12.88 (22.64) −15.18 (24.51) 0.51B
  Visit 6 −20.81 (22.75) −23.1 (24.43) 0.49A
  Visit 7 −21.69 (24.53) −27.49 (23.69) 0.09A
Night pain Visit 5 −15.07 (23.5) −13.96 (23.28) 0.87B
  Visit 6 −21.83 (26.37) −23.93 (22.41) 0.54A
  Visit 7 −23.28 (27.72) −25.27 (21.16) 0.56A
Motion pain Visit 5 −15.83 (20) −17.06 (24.32) 0.59B
  Visit 6 −22.67 (23.95) −25.86 (23.46) 0.34A
  Visit 7 −25.93 (26.59) −29.62 (22.21) 0.28A
Range of Knee Motion (°)
  Visit 5 135.39 (9.07) 134.02 (9.65) 0.27B
  Visit 6 135.29 (8.88) 134.35 (9.25) 0.46B
  Visit 7 135.71 (8.62) 134.99 (9.23) 0.51B
Swelling
  Visit 5 18 (16.22) 22 (22.68) 0.24C
  Visit 6 14 (12.61) 17 (17.53) 0.32C
  Visit 7 16 (14.41) 12 (12.37) 0.67C
Tenderness
  Visit 5 33 (29.73) 38 (39.18) 0.15C
  Visit 6 31 (27.93) 28 (28.87) 0.88C
  Visit 7 24 (21.62) 24 (24.74) 0.59C
  1. Data are mean (SD) except for swelling and tenderness, both of which are presented as number of patients (%)
  2. A, P-value obtained from two-sample t-test; B, P-value obtained from Wilcoxon’s rank sum test; C, P-value obtained from Chi-square test