Table 3 Primary and secondary outcomes. Results are listed for both the intention-to-treat group, which includes subjects who did not start or complete the 12-week program (ITT), as well as per protocol results for subjects that completed 12-week program (PP)

From: Randomized controlled trial of a 12-week digital care program in improving low back pain

   DCP at baseline, mean (SD) DCP at outcome, mean (SD) Control at baseline, mean (SD) Control at outcome, mean (SD) Group difference, mean (95% CI) Group difference, p-value
Primary outcomes
Korff pain ITT 51.1 (17.8) 33.8 (21.6) 51.4 (17.4) 50.5 (21.4) −16.4 [−22, −10.9] <0.001
  PP 48.8 (17.8) 23.4 (16.1) 47.5 (16.1) 49.1 (21.4) −26.9 [−33.8, −20] <0.001
Korff disability ITT 34.3 (23.1) 21.5 (19.6) 40.3 (24) 40.5 (25.7) −13 [−19.3, −6.7] <0.001
  PP 33.1 (24.3) 15 (15.5) 34.2 (20.2) 37.3 (24.3) −21.3 [−30.8, −11.7] <0.001
ODI ITT 21.7 (12.1) 17.6 (12) 21 (9.66) 21.1 (11.2) −4.1 [-6.5, −1.8] <0.001
  PP 19.7 (11.4) 13.5 (9.46) 18.9 (7.4) 19.7 (10.6) −6.9 [−10.5, −3.3] <0.001
Secondary outcomes
VAS Pain score ITT 46.3 (20.9) 25.8 (21.4) 45.4 (20.8) 40.8 (23.2) −16 [−22.5, −9.4] <0.001
  PP 43.6 (20.5) 16.5 (15.5) 42.6 (19.4) 39.2 (23.6) −23.7 [−31.9, −15.5] <0.001
VAS impact on daily life score ITT 38.6 (26.6) 21.1 (20.7) 43.9 (25.2) 38.2 (26.1) −11.8 [−19.3, −4.3] 0.002
  PP 37.3 (28.2) 13.4 (14.8) 40.9 (24.7) 35.3 (27.3) −18.3 [−29, −7.7] 0.001
Surgery interest ITT 0.894 (1.71) 0.619 (1.35) 1.39 (2.55) 1.53 (2.67) −0.4 [−0.7, −0.1] 0.01
  PP 0.681 (1.59) 0.333 (0.918) 0.639 (1.31) 0.972 (1.89) −0.7 [−1.2, −0.2] 0.006
Understanding of condition and treatment options (0-4) ITT 1.81 (0.95) 2.47 (1.07) 1.77 (1.03) 1.94 (0.871) 0.5 [0.2, 0.7] 0.0005
  PP 1.94 (0.838) 3 (0.594) 1.5 (1.06) 1.78 (0.797) 0.8 [0.4, 1.2] 0.0001
  1. All p-values are from two-sided statistical tests
  2. SD standard deviation, ODI Oswestry Disability Index, VAS visual analogue scale