Table 3 ShamVR between-group differences at End-of-Treatment and 12-Months post-treatment for the primary and secondary endpoints.
Mean (SD) score [No of participants] | Sham VR LICP vs HICP: Reduction from Baselinea | |||
---|---|---|---|---|
Time | Sham VR LICP | Sham VR HICP | Estimate (SE) [95% CI] | P valueb |
Brief Pain Inventory (BPI) Pain Interferencec | ||||
Baseline | 5.13 (1.31) [331] | 8.05 (0.80) [201] | ||
End-of-Treatment | 3.68 (2.09) [302] | 6.07 (2.23) [178] | 0.54 (0.18) [0.20 – 0.89] | 0.002 |
12-Months Post-Treatment | 4.14 (2.24) [262] | 6.08 (2.21) [149] | 1.00 (0.21) [0.61 – 1.44] | < 0.001 |
Brief Pain Inventory (BPI) Pain Intensityd | ||||
Baseline | 5.96 (1.27) [331] | 7.95 (0.88) [201] | ||
End-of-Treatment | 4.53 (2.09) [302] | 6.37 (2.02) [178] | 0.13 (0.18) [-0.22 – 0.47] | 0.47 |
12-Months Post-Treatment | 5.00 (2.10) [262] | 6.34 (2.13) [149] | 0.66 (0.21) [0.25 – 1.07] | 0.002 |
PROMIS Sleep Disturbancee | ||||
Baseline | 58.17 (6.31) [331] | 65.28 (6.77) [200] | ||
End-of-Treatment | 56.39 (7.53) [302] | 61.07 (7.64) [177] | 2.48 (0.58) [1.34 – 3.62] | < 0.001 |
12-Months Post-Treatment | 55.91 (7.50) [302] | 59.81 (8.59) [148] | 3.09 (0.74) [1.64 – 4.55] | < 0.001 |
PROMIS Depressionf | ||||
Baseline | 52.25 (8.28) [331] | 58.42 (8.62) [200] | ||
End-of-Treatment | 52.63 (8.61) [302] | 59.34 (8.86) [177] | -0.17 (0.74) [-1.61 – 1.28] | 0.82 |
12-Months Post-Treatment | 52.12 (9.02) [262] | 57.56 (9.72) [148] | 0.52 (0.92) [-1.29 – 2.33] | 0.57 |
Oswestry Disability Indexg | ||||
Baseline | 34.49 (13.66) [331] | 51.65 (16.41) [200] | ||
End-of-Treatment | 29.98 (14.84) [302] | 43.90 (18.53) [177] | 3.16 (1.17) [0.87 – 5.45] | 0.007 |
12-Months Post-Treatment | 29.41 (17.54) [262] | 41.90 (20.91) [148] | 4.61 (1.60) [1.46 – 7.75] | 0.004 |