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Table 2 Secondary outcome measures at baseline, 6 weeks and 3 months (mean (SD) unless otherwise stated)

From: HAPPi Kneecaps! A double-blind, randomised, parallel group superiority trial investigating the effects of sHoe inserts for adolescents with patellofemoral PaIn: phase II feasibility study

 

Contoured foot orthoses (n = 17)

Flat shoe insoles (n = 19)

Baseline

6 weeksa

3 monthsb

Baseline

6 weeksc

3 monthsd

Average pain severity [0-100 mm]

47.7 (16.1)

46.1 (21.7)

38.1 (21.2)

47.5 (23.2)

40.6 (23.5)

33.4 (20.7)

Worst pain severity [0-100 mm]

63.8 (16.7)

60 (23)

47.9 (23.8)

57.9 (24.4)

51.8 (28.8)

42.7 (24.1)

GROC, number (%)

completely recovered

0 (0)

1 (6.5)

0 (0)

0 (0)

strongly recovered

4 (33)

8 (53.5)

3 (27.3)

4 (36)

slightly recovered

5 (42)

4 (27)

3 (27.3)

5 (46)

same

2 (17)

1 (6.5)

3 (27.3)

2 (18)

slightly worse

0 (0)

0 (0)

1 (9)

0 (0)

much worse

1 (8)

1 (6.5)

1 (9)

0 (0)

Number (%) responding ‘yes’ to Patient Acceptable Symptom State

12 (71)

9 (75)

13 (87)

13 (68)

7 (64)

8 (73)

KOOS-Child [100–0]

Pain

63.4 (10.6)

66.7 (14.4)

81.3 (12.3)

63.5 (16.8)

68.2 (19.1)

79 (13.7)

Symptoms

77.5 (9.9)

77.1 (13.4)

88.5 (10.1)

75.4 (13.2)

77.6 (12.7)

84.7 (12.1)

ADL

82.2 (9.5)

86.4 (10.6)

94 (6.5)

79.1 (14.5)

87.2 (9.7)

93.8 (7)

Sport and play

62.4 (16.5)

69.3 (23.4)

81.6 (17.4)

62.2 (20.3)

72.1 (25.4)

87.3 (16.3)

QoL

57.1 (17.1)

61.1 (20.6)

78 (17.8)

52.9 (18.5)

64 (20)

75.4 (18.5)

 KOOS-PF [100–0]

60.6 (15.8)

65.1 (23)

82.6 (13.7)

58 (16.9)

70.9 (17.4)

80.4 (19.6)

 Anterior Knee Pain Scale [100–0]

74.7 (10.7)

75.5 (13.6)

85.5 (10.2)

72.6 (10.8)

79.4 (13.3)

87.5 (9.8)

 EQ-5D-5L index value [1–0]

0.72 (0.1)

0.68 (0.28)

0.83 (0.13)

0.71 (0.19)

0.76 (0.13)

0.85 (0.12)

 EQ-5D-5L VAS [100–0]

76.9 (15.1)

81.6 (20.7)

80.2 (17.7)

81.8 (10.7)

83 (12.6)

88.4 (7.6)

  1. GROC global rating of change, KOOS Knee injury and Osteoarthritis Outcome Score, ADL activities of daily living, QoL quality of life, KOOS-PF KOOS patellofemoral subscale, VAS visual analogue scale
  2. Square parentheses indicate possible score range, from best to worst possible score.
  3. Number of observations: a n = 12; b n = 15; c n = 11; d n = 11.