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Table 5 Participant-reported secondary outcome measures

From: Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial

  Treatment group Group difference P value*
Chiropractic care Integrated care Chiropractic care minus integrated care
Low back disability (Roland Morris) [0 to 100; lower scores indicate less disability]
Mean at baseline (SD) 40.9 (21.3) 38.1 (19.2)   
Mean at week 4 (95% CI) 30.3 (27 to 33.6) 27.0 (23.7 to 30.2) 3.07 (− 0.95 to 7.08) 0.14
Mean at week 12 (95% CI) 19.9 (16.6 to 23.2) 16.5 (13.3 to 19.7) 3.66 (− 0.65 to 7.97) 0.10
Short term response summary (area under the curve minus baseline through week 12)    3.36 (− 0.65 to 7.38) 0.10
Mean at week 26 (95% CI) 24.6 (21.2 to 27.9) 20.2 (16.9 to 23.4) 4.05 (− 0.97 to 9.07) 0.12
Mean at week 52 (95% CI) 25.6 (22.1 to 29) 19.0 (15.7 to 22.3) 6.54 (1.18 to 11.90) 0.02
Long term response summary (area under the curve minus baseline through week 52)    4.62 (0.88 to 8.36) 0.02
Improvement [1 to 9; 1 = 100% Improvement, 9 = 100% Worse]
Mean at week 4 (95% CI) 3.9 (3.6 to 4.1) 3.6 (3.3 to 3.8) 0.31 (0.03, 0.60) 0.03
Mean at week 12 (95% CI) 3.1 (2.9 to 3.4) 2.8 (2.6 to 3.1) 0.29 (− 0.04, 0.63) 0.09
Short term response summary
(Area under the curve through week 12)
   0.31 (0.01 to 0.61) 0.04
Mean at week 26 (95% CI) 3.5 (3.2 to 3.8) 3.1 (2.8 to 3.3) 0.38 (0.08, 0.68) 0.01
Mean at week 52 (95% CI) 3.6 (3.3 to 3.9) 3.1 (2.8 to 3.3) 0.37 (0.08, 0.65) 0.01
Long term response summary (area under the curve through week 52)    0.41 (0.14 to 0.68)  < 0.01
Medication use [days/week]
Mean at baseline (SD) 2.8 (2.4) 2.9 (2.4)   
Mean at week 4 (95% CI) 2.3 (1.9 to 2.7) 2.6 (2.2 to 3) − 0.27 (− 0.77 to 0.24)  
Mean at week 12 (95% CI) 1.8 (1.4 to 2.2) 1.8 (1.4 to 2.2) − 0.05 (− 0.63 to 0.52)  
Short term response summary (area under the curve minus baseline through week 12)    − 0.21 (− 0.71 to 0.30)  
Mean at week 26 (95% CI) 1.8 (1.4 to 2.2) 2.2 (1.8 to 2.6) − 0.44 (− 1.06 to 0.19)  
Mean at week 52 (95% CI) 2.3 (1.9 to 2.8) 1.9 (1.5 to 2.4) 0.50 (− 0.17 to 1.17)  
Long term response summary (area under the curve minus baseline through week 52)    − 0.11 (− 0.58 to 0.36) 0.65
Quality of life (EuroQol) [− 0.109 to 1; higher scores indicate better quality of life]
Mean at baseline (SD) 0.76 (0.10) 0.79 (0.06)   
Mean at week 4 (95% CI) 0.80 (0.78 to 0.82) 0.81 (0.79 to 0.83) − 0.01 (− 0.04 to 0.02)  
Mean at week 12 (95% CI) 0.83 (0.81 to 0.85) 0.85 (0.83 to 0.87) − 0.02 (− 0.05 to 0.01)  
Short term response summary (area under the curve minus baseline through week 12)    − 0.01 (− 0.04 to 0.01)  
Mean at week 26 (95% CI) 0.81 (0.79 to 0.83) 0.82 (0.80 to 0.84) − 0.02 (− 0.04 to 0.01)  
Mean at week 52 (95% CI) 0.82 (0.79 to 0.84) 0.84 (0.82 to 0.86) − 0.02 (− 0.05 to 0.004)  
Long term response summary (area under the curve minus baseline through week 52)    − 0.02 (− 0.04 to 0.003) 0.09
Satisfaction with care [1 to 7; 1 = Completely Satisfied, 7 = Completely Dissatisfied]
Mean at week 4 (95% CI) 2.1 (1.9 to 2.3) 1.8 (1.6 to 2) 0.34 (0.12, 0.57)  < 0.01
Mean at week 12 (95% CI) 2 (1.8 to 2.2) 1.7 (1.5 to 1.9) 0.33 (0.09, 0.56)  < 0.01
Short term response summary (area under the curve minus baseline through week 12)    0.34 (0.11 to 0.56)  < 0.01
Mean at week 26 (95% CI) 2.3 (2.1 to 2.5) 1.9 (1.7 to 2.1) 0.38 (0.08, 0.68) 0.01
Mean at week 52 (95% CI) 2.2 (2 to 2.4) 1.8 (1.6 to 2) 0.37 (0.08, 0.65) 0.01
Long term response summary (area under the curve through week 52)    0.38 (0.16 to 0.59)  < 0.01
Low back symptom frequency [0 to 5; 0 = none of the time, 5 = all of the time]
Mean at baseline (SD)     
Mean at week 4 (95% CI) 3.11 (2.9 to 3.32) 2.83 (2.62 to 3.04) 0.28 (− 0.01 to 0.58) 0.06
Mean at week 12 (95% CI) 2.38 (2.17 to 2.59) 2.02 (1.81 to 2.23) 0.36 (0.06 to 0.66) 0.02
Short term response summary
(Area under the curve minus baseline through week 12)
   0.31 (0.07 to 0.56) 0.01
Mean at week 26 (95% CI) 2.68 (2.47 to 2.9) 2.33 (2.12 to 2.54) 0.35 (0.05 to 0.66) 0.02
Mean at week 52 (95% CI) 2.41 (2.19 to 2.64) 1.95 (1.74 to 2.16) 0.46 (0.16 to 0.77) 0.003
Long term response summary (area under the curve through week 52)    0.38 (0.15 to 0.60) 0.001
Leg symptom frequency [0 to 5; 0 = none of the time, 5 = all of the time]
Mean at baseline (SD)
Mean at week 4 (95% CI) 1.1 (0.92 to 1.28) 1.03 (0.85 to 1.21) 0.07 (− 0.19 to 0.32)  
Mean at week 12 (95% CI) 0.77 (0.58 to 0.95) 0.66 (0.49 to 0.84) 0.1 (− 0.15 to 0.36)  
Short term response summary
(Area under the curve minus baseline through week 12)
   0.08 (− 0.13 to 0.29)  
Mean at week 26 (95% CI) 0.94 (0.75 to 1.12) 0.87 (0.69 to 1.05) 0.07 (− 0.2 to 0.33)  
Mean at week 52 (95% CI) 1.04 (0.85 to 1.24) 0.79 (0.6 to 0.97) 0.26 (− 0.01 to 0.52)  
Long term response summary
(Area under the curve through week 52)
   0.12 (− 0.06 to 0.31) 0.19
Any missed work days due to back problem in past month [%]
Percentage at baseline (n) 36.3 (36) 36.6 (37)   
Percentage at week 4 (95% CI) 23.5 (16.4 to 30.5) 24.2 (17.4 to 31.0) − 0.7 (− 10.2 to 8.7)  
Percentage at week 12 (95% CI) 17.5 (11.0 to 24.1) 13.0 (8.2 to 17.8) 4.5 (− 3.1 to 12.1)  
Percentage at week 26 (95% CI) 15.2 (9.4 to 21.1) 16.6 (10.6 to 22.6) − 1.3 (− 9.1 to 6.5)  
Percentage at week 52 (95% CI) 17.3 (10.5 to 24.1) 16.1 (9.9 to 22.3) 1.2 (− 7.6 to 10.0)  
Number of missed work days due to back problem in past month [0–31 days]
Mean at baseline (SD) 6.0 (4.9) 6.6 (6.8)   
Mean at week 4 (95% CI) 6.09 (3.56 to 8.62) 4.49 (3.13 to 5.85) 1.60 (− 1.29 to 4.49)  
Mean at week 12 (95% CI) 2.18 (1.35 to 3.01) 3.84 (1.55 to 6.12) − 1.65 (− 4.12 to 0.81)  
Mean at week 26 (95% CI) 6.23 (1.33 to 11.14) 5.38 (0.54 to 10.21) 0.86 (− 6.07 to 7.78)  
Mean at week 52 (95% CI) 3.16 (1.98 to 4.33) 6.11 (0.20 to 12.02) − 2.96 (− 9.03 to 3.11)  
Any reduced activity days due to back problem in past month [%]
Percentage at baseline (n) 74.0 (74) 72.2 (73)   
Percentage at week 4 (95% CI) 54.4 (45.7 to 63.1) 64.8 (56.5 to 73.1) − 10.4 (− 22.4 to 1.6)  
Percentage at week 12 (95% CI) 41.3 (31.4 to 51.2) 41.8 (32.9 to 50.8) − 0.6 (− 13.9 to 12.8)  
Percentage at week 26 (95% CI) 43.7 (34.7 to 52.7) 37.1 (30.0 to 44.2) 6.6 (− 4.4 to 17.6)  
Percentage at week 52 (95% CI) 41.5 (32.6 to 50.4) 34.7 (26.9 to 42.5) 6.8 (− 4.5 to 18.2)  
Number of reduced activity days due to back problem in past month [0–31 days]
Mean at baseline (SD) 9.0 (8.2) 8.4 (8.0)   
Mean at week 4 (95% CI) 6.05 (5.02 to 7.08) 5.07 (4.19 to 5.95) 0.98 (− 0.26 to 3.01)  
Mean at week 12 (95% CI) 5.04 (3.10 to 6.99) 4.22 (3.10 to 5.35) 0.82 (− 1.37 to 3.01)  
Mean at week 26 (95% CI) 4.58 (3.56 to 5.60) 4.53 (3.55 to 5.51) 0.05 (− 1.24 to 1.33)  
Mean at week 52 (95% CI) 4.84 (3.36 to 6.33) 4.53 (3.54 to 5.52) 0.31 (− 1.34 to 1.96)  
Fear avoidance beliefs—work subscale [0–42; higher scores indicate greater fear avoidance beliefs]
Mean at baseline (SD) 9.13 (8.94) 9.69 (8.47)   
Mean at week 4 (95% CI) 8.30 (7.15 to 9.45) 7.53 (6.4 to 8.66) 0.77 (− 0.84 to 2.38)  
Mean at week 12 (95% CI) 7.10 (5.94 to 8.26) 5.94 (4.82 to 7.06) 1.16 (− 0.45 to 2.77)  
Short term response summary (area under the curve minus baseline through week 12)    0.93 (− 0.46 to 2.31)  
Mean at week 26 (95% CI) 6.80 (5.62 to 7.98) 5.65 (4.51 to 6.78) 1.15 (− 0.48 to 2.79)  
Mean at week 52 (95% CI) 6.60 (5.39 to 7.81) 6.49 (5.34 to 7.64) 0.11 (− 1.56 to 1.78)  
Long term response summary (area under the curve through week 52)    0.84 (− 0.44 to 2.11) 0.20
Fear avoidance beliefs—physical activity subscale [0 to 24; higher scores indicate greater fear avoidance beliefs]
Mean at baseline (SD) 11.66 (5.42) 11.63 (5.32)   
Mean at week 4 (95% CI) 9.03 (8.04 to 10.01) 9.3 (8.33 to 10.27) − 0.28 (− 1.66 to 1.11)  
Mean at week 12 (95% CI) 7.54 (6.55 to 8.54) 7.36 (6.39 to 8.33) 0.18 (− 1.21 to 1.57)  
Short term response summary
(Area under the curve minus baseline through week 12)
   − 0.09 (− 1.31 to 1.12)  
Mean at week 26 (95% CI) 7.71 (6.7 to 8.72) 6.52 (5.53 to 7.5) 1.20 (− 0.21 to 2.6)  
Mean at week 52 (95% CI) 7.61 (6.57 to 8.64) 7.22 (6.23 to 8.21) 0.39 (− 1.04 to 1.82)  
Long term response summary (area under the curve through week 52)    0.59 (− 0.55 to 1.72) 0.31
Self-efficacy [0 to 60; higher scores indicate greater self-efficacy]
Mean at baseline (SD) 48.0 (10.0) 49.2 (8.7)   
Mean at week 4 (95% CI) 52.2 (50.9 to 53.6) 52 (50.7 to 53.4) 0.18 (− 1.70 to 2.07)  
Mean at week 12 (95% CI) 54.4 (53 to 55.7) 54.7 (53.4 to 56) − 0.33 (− 2.22 to 1.57)  
Short term response summary (area under the curve minus baseline through week 12)    − 0.02 (− 1.67 to 1.63)  
Mean at week 26 (95% CI) 52.5 (51.2 to 53.9) 53.2 (51.8 to 54.5) − 0.63 (− 2.55 to 1.29)  
Mean at week 52 (95% CI) 51.8 (50.4 to 53.2) 53.8 (52.5 to 55.2) − 1.99 (− 3.94 to − 0.04)  
Long term response summary (area under the curve through week 52)    − 0.82 (− 2.35 to 0.71) 0.29
Active pain coping strategies (pain management inventory) [5 to 25; higher scores indicate more frequent use]
Mean at baseline (SD) 17.3 (3.4) 17.1 (3.6)   
Mean at week 12 (95% CI) 18.2 (17.6 to 18.9) 19.0 (18.4 to 19.7) − 0.8 (− 1.7 to 0.1) 0.07
Passive pain coping strategies (Pain Management Inventory) [6 to 30; higher scores indicate more frequent use]
Mean at baseline (SD) 13.8 (4.5) 13.9 (3.9)   
Mean at week 12 (95% CI) 12.6 (12.0 to 13.2) 11.7 (11.1 to 12.3) 0.9 (0.1 to 1.7) 0.036
Kinesiophobia [17 to 68] (11 questions; 1 = Strongly Disagree—4 = Strongly Agree)
Mean at baseline (SD) 35.2 (6.3) 33.2 (5.8)   
Mean at week 12 (95% CI) 29.7 (28.6 to 30.8) 28.7 (27.6 to 29.8) 1.0 (2.6 to − 0.6) 0.20
  1. Mean values adjusted for baseline except for improvement and satisfaction
  2. *Long term response summary serves as the omnibus test p-value. If p > .05, p-values for short term response and individual time points are not computed