Table 2.
Primary and main secondary outcomes until 12 weeks (intergroup comparison), and until 52 weeks, patients of the control group started to receive OM treatment after week 12.
| n | Osteopathic medicine group-adjusted mean, (95% CI)a | Control group-adjusted mean, (95% CI)a | Differences (osteopathic medicine group − control group) adjusted mean, (95% CI)a | p | |
|---|---|---|---|---|---|
| VAS neck pain (0−100 mm)* (average neck pain during the previous 7 days), MCID 15 mm, SBC 26.5 mm | |||||
| 6 weeks | 57 | 21.9 (14.7; 29.1) | 42.8 (36.2; 49.4) | −20.9 (−30.7; −11.1) | <0.001 |
| 12 weeks (primary outcome) | 61 | 14.6 (8.0; 21.2) | 40.8 (34.7; 46.9) | −26.2 (−35.2; −17.2) | <0.001 |
| 26 weeks*** | 58 | 20.5 (12.0; 29.0) | 35.8 (28.2; 43.5) | *** | *** |
| 52 weeks*** | 56 | 19.7 (12.2; 27.7) | 30.6 (23.8; 37.5) | *** | *** |
| Neck pain disability by NDI (0−100%)*, MCID 9.8% | |||||
| 6 weeks | 61 | 14.1 (11.8; 16.4) | 18.6 (16.4; 20.7) | −4.5 (−7.7; −1.4) | 0.006 |
| 12 weeks | 61 | 8.8 (6.7; 10.8) | 17.2 (15.3; 19.1) | −8.4 (−11.2; −5.6) | <0.001 |
| 26 weeks*** | 58 | 10.8 (8.0; 13.7) | 15.1 (12.5; 17.6) | *** | *** |
| 52 weeks*** | 57 | 10.3 (7.6; 13.0) | 14.0 (11.5; 16.6) | *** | *** |
| VAS stress (0−100 mm)* | |||||
| 6 weeks | 61 | 40.7 (32.3; 49.0) | 51.5 (43.8; 59.2) | −10.8 (−22.4; 0.8) | 0.067 |
| 12 weeks | 61 | 30.4 (21.6; 39.2) | 46.1 (38.0; 54.2) | −15.7 (−27.9; −3.4) | 0.013 |
| 26 weeks*** | 58 | 39.8 (28.6; 50.9) | 44.2 (34.2; 54.2) | *** | *** |
| 52 weeks*** | 57 | 35.0 (25.2; 44.8) | 41.8 (32.4; 51.0) | *** | *** |
| SF-12 physical component scale (0–100)**, MCID 5 points | |||||
| 6 weeks | 59 | 51.2 (49.1; 53.3) | 48.2 (46.3; 50.2) | 3.0 (0.1; 5.8) | 0.044 |
| 12 weeks | 59 | 53.1 (51.2; 54.9) | 49.1 (47.3; 50.8) | 4.0 (1.5; 6.6) | 0.003 |
| 26 weeks*** | 55 | 52.9 (50.6; 55.2) | 49.7 (47.7; 51.8) | *** | *** |
| 52 weeks*** | 54 | 51.7 (49.2; 54.1) | 49.6 (47.2; 52.0) | *** | *** |
| SF-12 mental component scale (0–100)**, MCID 5 points | |||||
| 6 weeks | 59 | 48.0 (44.6; 51.2) | 46.7 (43.7; 49.7) | 1.3 (–3.1; 5.7) | 0.563 |
| 12 weeks | 59 | 49.8 (46.3; 53.3) | 47.5 (44.4; 50.7) | 2.0 (–1.4; 5.5) | 0.335 |
| 26 weeks*** | 55 | 47.9 (44.3; 51.5) | 47.6 (44.4; 50.8) | *** | *** |
| 52 weeks*** | 54 | 49.3 (45.3; 53.3) | 44.3 (40.5; 48.2) | *** | *** |
a
Results adjusted for respective baseline value.
*
lower values indicate better status.
**
higher values indicate better status.
***
no comparison and no p-values, because after 12 weeks n = 28 (82.4%) participants of the control group started to receive OM treatment.
CI, confidence interval; MCID, minimal clinically important difference; n, number for respective available data from n = 61 patients; NDI, Neck Disability Index; SBC, substantial clinical benefit; SF-12, 12-item Short Form Health Survey; VAS, visual analog scale.