Table 2.
Differences in Primary and Secondary Outcomes from the Baseline to the Fourth Treatment Week. Analysis is per Protocol
| Intervention Group (n= 19) | Control Group (n = 25) | Between-Group Change Comparison | ||||
|---|---|---|---|---|---|---|
| Within-Group Change Between Baseline to 4-Weeks | P-value | Within-Group Change Between Baseline to 4-Weeks | P-value | Mean Difference with 95% CI | P-value | |
| Primary outcome | ||||||
| Nightly posterior pain, VASa | −14.9 (29.4) [−34.3;0.3] −11.3 {76.6;40.0} | 0.033 | 1.6 (20.2) [−2.1;10.7] 4.0 {-63.3;31.0} | 0.34 | 16.5 [1.4;31.6] | 0.028 |
| Secondary outcomes | ||||||
| Nightly anterior pain, VASa | −8.4 (27.3) [−20.1;12.3] −1.4 {-72.7; 33.4} | 0.26 | 2.6 (11.7) [−4.5;12.9] 0.8 {-26.4; 24.7} | 0.24 | 11.0 [−1.3;23.2] | 0.28 |
| Evening anterior pain, VASa | −5.5 (24.0) [−22.0;11.7] −1.6 {-71.1;25.7} | 0.52 | 2.8 (16.1) [−4.3;8.9] 2.2 {-27.9;40.7} | 0. 35 | 8.3 [−4.0;20.5] | 0.43 |
| Evening posterior pain, VASa | −14.4 (22.1) [−21.7;0.2] −7.8 {-81.6;12.0} | 0.008 | −3.2 (21.2) [−14.0;9.3] −0.5 {-66.2;34.0} | 0.72 | 11.2 [−2.1;24.5] | 0.066 |
| Women on sick leaveb | 1 (5.3%) | 1.00 | 0 (0%) | 1.00 | 0.71 | |
| Sleep duration, minutesa | 25.6 (71.8) [8.6;68.6] 25.7 {-205.7;111.4} | 0.022 | 13.8 (25.1) [0.0;34.3] 8.1 {-30.9;60.0} | 0.014 | −11.8 [−43.5;19.9] | 0.046 |
| Nightly wake upsa | −1.1 (1.9) [−2.2;0.6] −0.7 {-4.6;1.6} | 0.049 | −0.2 (0.8) [−0.8;0.3] −0.2 {-1.5;1.2} | 0.29 | 0.9 [0.07;1.8] | 0.15 |
| PGQa | 1.0 (8.2) [−4.0;7.0] 2.0 {-17;16} | 0.48 | 4.5 (8.2) [−1.0;8.0] 3.0 {-8;25} | 0.018 | 3.6 [−1.5;8.7] | 0.33 |
| EQ-VASa | 4.5 (20.7) [−8.0;20.0] 2.5 {-30;47} | 0.36 | −2.0 (17.2) [−4.0;2.0] 0.0 {-49;37} | 0.67 | −6.5 [−18.0;5.0] | 0.36 |
| ESSa | −0.1 (3.1) [−3.0;3.0] 0.0 {-5;6} | 0.81 | 1.0 (1.9) [0.0;2.0] 1.0 {-2;5} | 0.021 | 1.1 [−0.4;2.6] | 0.20 |
| PCS, total scorea | −6.4 (8.6) [−14.0;-2.0] −5.0 {-22;10} | 0.005 | −3.0 (5.7) [−5.0;0.0] −3.0 {-15;13} | 0.010 | 3.3 [−1.1;7.7] | 0.20 |
Notes: For categorical variables n (%) is presented; For continuous variables Mean (SD) [95% CI] Median {Min-Max} is presented; ap-values between groups from Mann–Whitney U-test and within group from Wilcoxon Signed rank test; bp-values between groups from Fishers Exact test and within groups from Sign test.
Abbreviations: ESS, Epworth sleepiness scale; EQ-VAS, European quality of life measure visual analogue scale; PCS, pain catastrophizing scale; PGQ, pelvic girdle questionnaire; VAS, visual analogue scale.