Table 4.
Additional Outcomes.
| Additional measure | SQS + OMM | OMM alone |
Between group p‐value * |
||||
|---|---|---|---|---|---|---|---|
| Baseline | Nine months | Absolute change from baseline [%, SD] | Baseline | Nine months | Absolute change from baseline [%, SD] | ||
| Oswestry disability index mean (SD) † | |||||||
| ITT | 51.9 ± 13.2 | 42.1 ± 18.0 | −12.4 ± 16.5 | 47.1 ± 11.8 | 46.6 ± 11.6 | −0.1 ± 8.3 | <0.0001 |
| PT | 52.8 ± 12.1 | 40.7 ± 15.2 | −12.1 ± 16.3 | 47.0 ± 11.5 | 46.7 ± 12.3 | −0.3 ± 8.1 | <0.0001 |
| SF‐36 physical component score mean (SD) ‡ | |||||||
| ITT | 28.5 ± 6.3 | 30.4 ± 6.3 | 2.1 ± 6.4 | 30.2 ± 5.2 | 30.4 ± 5.6 | 1.0 ± 5.2 | 0.293 |
| PT | 29.0 ± 5.9 | 30.3 ± 6.4 | 1.2 ± 5.7 | 29.2 ± 5.7 | 30.3 ± 5.6 | 1.1 ± 5.3 | 0.335 |
| SF‐36 mental component score mean (SD) ‡ | |||||||
| ITT | 42.0 ± 10.9 | 44.8 ± 11.5 | 3.8 ± 11.3 | 45.2 ± 11.1 | 45.4 ± 11.1 | −1.6 ± 8.4 | 0.0062 |
| PT | 41.2 ± 10.1 | 45.6 ± 10.5 | 4.4 ± 10.9 | 47.0 ± 9.9 | 46.0 ± 11.5 | −1.0 ± 7.8 | 0.0359 |
| Leg Pain VAS (SD) † | |||||||
| ITT | 8.9 ± 10.8 | 12.3 ± 17.8 | 5.2 ± 14.9 | 6.8 ± 11.5 | 5.9 ± 11.4 | 1.0 ± 5.2 | 0.543 |
| PT | 7.2 ± 8.2 | 8.4 ± 11.8 | 1.1 ± 8.4 | 4.6 ± 7.7 | 8.1 ± 17.6 | 3.5 ± 12.9 | 0.045 |
| EQ‐5D‐5L utility score with a UK value set; mean (SD) ‡ | |||||||
| ITT | 0.40 ± 0.22 | 0.56 ± 0.29 | 0.19 ± 0.25 | 0.43 ± 0.23 | 0.45 ± 0.22 | −0.01 ± 0.15 | 0.0003 |
| PT | 0.39 ± 0.20 | 0.59 ± 0.27 | 0.20 ± 0.24 | 0.45 ± 0.22 | 0.45 ± 0.22 | −0.00 ± 0.16 | <0.0001 |
| Patient global impression of change categories of very much improved and much improved (N, %) | |||||||
| ITT | N/A | 20 (33.3%) | N/A | N/A | 1 (1.7%) | N/A | <0.0001 |
| PT | N/A | 18 (60%) | N/A | N/A | 1 (2.9%) | N/A | <0.0001 |
| Would recommend their treatment to patients suffering similar pain (Yes: N, %) | |||||||
| ITT | N/A | 33 (58.9%) | N/A | N/A | 29 (48.3%) | N/A | 0.547 |
| PT | N/A | 27 (90.0%) | N/A | N/A | 27 (77.1%) | N/A | 0.2012 |
| Based on experience, would agree to their treatment again (Yes: N, %) | |||||||
| ITT | N/A | 29 (48.3%) | N/A | N/A | 32 (57.1%) | N/A | 0.644 |
| PT | N/A | 27 (90.0%) | N/A | N/A | 27 (77.1%) | N/A | 0.2012 |
*Between group p‐value of treatment effect in linear regression model.
†A negative change indicates an improvement in between baseline and follow‐up visits.
‡A positive change indicates an improvement in between baseline and follow‐up visits.
ITT, intent‐to‐treat; N/A, not applicable; PT, per‐treatment; SD, standard deviation; VAS, visual analog scale.