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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.