Table 2.
Changes in primary and secondary outcomes*.
| Variable | Outcomes of different timepoints (means ± SD)▾ | Mean change from baseline (95% CI) | Between-group difference (95% CI) | P value§ | ||
|---|---|---|---|---|---|---|
| Experimental group (N = 306) |
Control group (N = 102) |
Experimental group (N = 306) |
Control group (N = 102) |
Experimental group versus control group | ||
| VAS scores※ | ||||||
| M1 | 53.94 ± 19.60 | 56.00 ± 19.61 | — | — | — | 0.358 |
| M2 | 24.48 ± 17.73 | 43.16 ± 20.75 | −29.46 (−31.52 to −27.40) | −12.84 (−15.58 to −9.83) | −16.62 (−20.25 to −12.98) | <0.001 |
| M3 | 7.40 ± 6.52 | 15.83 ± 11.61 | −46.54 (−48.50 to −44.57) | −40.17 (−43.26 to −37.07) | −6.37 (−10.20 to −2.54) | 0.001 |
| M4 | 2.32 ± 2.29 | 7.94 ± 6.76 | −51.62 (−53.73 to −49.51) | −48.06 (−51.45 to −44.67) | −3.56 (−7.69 to 0.57) | 0.091 |
| C-SFODI† | ||||||
| M1 | 46.07 ± 20.56 | 49.59 ± 22.53 | — | — | — | 0.145 |
| M2 | 20.20 ± 13.79 | 39.26 ± 22.84 | −25.88 (−27.70 to −24.05) | −10.33 (−13.17 to −7.48) | −15.55 (−18.92 to −12.18) | <0.001 |
| M3 | 6.69 ± 5.98 | 21.57 ± 15.35 | −39.38 (−41.33 to −37.44) | −28.02 (−30.64 to −25.39) | −11.37 (−14.62 to −8.11) | <0.001 |
| M4 | 2.16 ± 2.01 | 13.36 ± 10.64 | −43.91 (−46.07 to −41.75) | −36.23 (−39.30 to −33.16) | −7.68 (−11.42 to −3.94) | <0.001 |
*Values are means with means ± SD or the 95% confidence (CI). M1: measurements were obtained at baseline; M2: immediately after the last intervention; M3: one month after the last intervention; M4: six months after the last intervention.
▾The VAS scores means at different timepoints between two groups were analyzed by repeated measures analysis of variance. Within-subjects effects tests of different timepoints means, F = 1381.914, P < 0.001. Between-subjects effects tests of different group means, F = 46.322, P < 0.001. The C-SFODI means at different timepoints between two groups were analyzed by repeated measures analysis of variance. Within-subjects effects tests of different timepoints means, F = 1076.327, P < 0.001. Between-subjects effects tests of different group means, F = 78.879, P < 0.001.
§ P values were calculated with independent-samples t-test for mean change from baseline between two groups.
※Visual analogue scale (VAS, scores range 0 to 100) with higher scores indicating greater pain.
†The Chinese Short Form Oswestry Disability Index (C-SFODI, range 0 to 100%) consists of 9 questions, with higher percentage indicating more severe functional disability.