Table 4.
Participant-reported secondary outcome measures
| Treatment group | Group difference | |||
|---|---|---|---|---|
| ET | SMT+ET | SMT+ET minus ET | P Value* | |
| Low back disability (Roland Morris) [0–18] | ||||
| Mean at Week 0 (SD) | 4.85 (3.15) | 5.64 (3.24) | ||
| Mean reduction at week 4 (95%CI) |
0.69 (0.13 to 1.26) | 0.46 (−0.09 to 1.02) | −0.23 (−1.03 to 0.56) | 0.57 |
| Mean reduction at week 8 (95%CI) |
1.03 (0.46 to 1.60) | 1.41 (0.85 to 1.96) | 0.38 (−0.42 to 1.17) | 0.36 |
| Mean reduction at week 12 (95%CI) |
1.78 (1.22 to 2.35) | 2.33 (1.77 to 2.89) | 0.54 (−0.25 to 1.34) | 0.18 |
| Short term response summary (Area under the curve minus baseline through week 12) |
0.99 (0.17 to 1.81) | 1.15 (0.34 to 1.97) | 0.17 (−0.54 to 0.88) | 0.65 |
| Mean reduction at week 26 (95%CI) |
2.41 (1.83 to 2.99) | 3.24 (2.68 to 3.81) | 0.84 (0.03 to 1.65) | 0.04 |
| Mean reduction at week 52 (95%CI) |
2.87 (2.30 to 3.45) | 3.51 (2.94 to 4.08) | 0.64 (−0.17 to 1.45) | 0.12 |
| Long term response summary (Area under the curve minus baseline through week 52) |
2.11 (1.33 to 2.88) | 2.72 (1.95 to 3.49) | 0.61 (0.004 to 1.21) | 0.048 |
| Improvement [1–9] † | ||||
| Mean at week 4 (95%CI) | 3.83 (3.59 to 4.08) | 3.85 (3.60 to 4.09) | 0.01 (−0.33 to 0.36) | 0.94 |
| Mean at week 8 (95%CI) | 3.46 (3.21 to 3.71) | 3.20 (2.96 to 3.45) | −0.26 (−0.60 to 0.09) | 0.15 |
| Mean at week 12 (95%CI) | 3.02 (2.77 to 3.27) | 2.78 (2.54 to 3.03) | −0.24 (−0.59 to 0.11) | 0.18 |
| Short term response summary (Area under the curve through week 12) |
3.53 (2.14 to 4.91) | 3.38 (1.98 to 4.78) | −0.14 (−0.44 to 0.15) | 0.34 |
| Mean at week 26 (95%CI) | 3.00 (2.74 to 3.25) | 2.58 (2.33 to 2.83) | −0.41 (−0.77 to −0.06) | 0.02 |
| Mean at week 52 (95%CI) | 2.99 (2.74 to 3.24) | 2.73 (2.49 to 2.98) | −0.26 (−0.61 to 0.10) | 0.16 |
| Long term response summary (Area under the curve through week 52) |
3.11 (1.73 to 4.49) | 2.81 (1.42 to 4.21) | −0.29 (−0.57 to −0.02) | 0.03 |
| Medication use [days/week] | ||||
| Mean at Week 0 (SD) | 2.79 (1.53) | 2.96 (1.32) | ||
| Mean reduction at week 4 (95%CI) |
2.12 (1.87 to 2.37) | 2.29 (2.05 to 2.54) | 0.18 (−0.17 to 0.53) | |
| Mean reduction at week 8 (95%CI) |
2.06 (1.80 to 2.31) | 2.43 (2.19 to 2.68) | 0.38 (0.02 to 0.73) | |
| Mean reduction at week 12 (95%CI) |
2.26 (2.01 to 2.51) | 2.46 (2.21 to 2.71) | 0.20 (−0.15 to 0.55) | |
| Short term response summary (Area under the curve minus baseline through week 12) |
2.34 (1.98 to 2.70) | 2.60 (2.24 to 2.96) | 0.26 (−0.04 to 0.56) | |
| Mean reduction at week 26 (95%CI) |
2.27 (2.02 to 2.53) | 2.40 (2.15 to 2.64) | 0.12 (−0.24 to 0.48) | |
| Mean reduction at week 52 (95%CI) |
2.35 (2.10 to 2.61) | 2.53 (2.28 to 2.78) | 0.18 (−0.18 to 0.54) | |
| Long term response summary (Area under the curve minus baseline through week 52) |
2.48 (2.13 to 2.83) | 2.65 (2.30 to 3.01) | 0.17 (−0.10 to 0.45) | 0.22 |
| Pediatric quality of life (PedsQL) [0–100] | ||||
| Mean at Week 0 (SD) | 73.2 (12.8) | 73.5 (11.2) | ||
| Mean improvement at week 12 (95%CI) |
7.56 (5.45 to 9.68) | 8.90 (6.81 to 10.98) | 1.33 (−1.64 to 4.31) | |
| Mean improvement at week 26 (95%CI) |
8.64 (6.51 to 10.77) | 11.36 (9.26 to 13.45) | 2.72 (−0.27 to 5.71) | |
| Mean improvement at week 52 (95%CI) |
9.81 (7.67 to 11.95) | 11.82 (9.71 to 13.93) | 2.02 (−0.99 to 5.02) | |
| Long term response summary (Area under the curve minus baseline through week 52) |
8.70 (6.95 to 10.45) | 10.67 (8.95 to 12.39) | 1.97 (−0.48 to 4.43) | 0.12 |
| Satisfaction with care [1–7]^ | ||||
| Mean at week 12 (95%CI) | 2.37 (2.14 to 2.60) | 2.00 (1.77 to 2.23) | −0.37 (−0.70 to −0.05) | 0.02 |
| Mean at week 26 (95%CI) | 2.33 (2.10 to 2.56) | 1.84 (1.61 to 2.07) | −0.49 (−0.81 to −0.16) | 0.003 |
| Mean at week 52 (95%CI) | 2.32 (2.08 to 2.55) | 1.92 (1.69 to 2.15) | −0.40 (−0.72 to −0.07) | 0.02 |
| Long term response summary (Area under the curve through week 52) |
2.35 (1.99 to 2.71) | 1.92 (1.56 to 2.28) | −0.43 (−0.71 to −0.15) | 0.003 |
Mean values adjusted for minimization variables and baseline where indicated.
*
Long term response summary serves as the omnibus test p-value. If p>.05, p-values for individual time points are not computed.
†
1 = 100% improvement
^
1 = completely satisfied