Table 2.
Visual analogue scale (VAS) scores at W0, W4, and W12.
| W0 | W4 | W12 |
p-Value LMM |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Values | Value | Difference (95% CI) |
p-Value 1 | Values | Difference (95% CI) |
p-Value 1 | ||||||
| 6AA | Placebo | 6AA | Placebo | 6AA | Placebo | |||||||
| VAS1 | Pain | 38.0 | 33.1 | 30.0 | 32.7 | −7.6 | 0.0001 * | 19.7 | 26.9 | −12.2 | 0.0123 * | 0.0023 * |
| (22.2) | (20.2) | (20.6) | (20.7) | (−11.1 to −4.2) | (20.1) | (17.6) | (−21.6 to −2.8) | |||||
| Discomfort | 38.7 | 34.8 | 28.6 | 34.4 | −9.7 | 0.0001 * | 19.3 | 27.6 | −12.2 | 0.0121 * | 0.0040 * | |
| (22.7) | (20.9) | (21.0) | (21.7) | (−14.3 to −5.0) | (18.9) | (18.2) | (−21.5 to −2.8) | |||||
| Stiffness | 35.5 | 30.6 | 27.8 | 29.8 | −7.0 | 0.0023 * | 19.6 | 25.9 | −11.3 | 0.0250 * | 0.0055 * | |
| (24.8) | (20.2) | (21.6) | (19.7) | (−11.3 to −2.6) | (18.5) | (18.0) | (−21.2 to −1.5) | |||||
| VAS2 | Pain | 46.1 | 42.0 | 34.6 | 41.2 | −10.8 | 0.0004 * | 25.4 | 34.6 | −13.4 | 0.0059 * | 0.0024 * |
| (22.4) | (22.4) | (23.3) | (22.0) | (−16.5 to −5.0) | (22.3) | (20.5) | (−22.7 to −4.0) | |||||
| Discomfort | 44.6 | 41.3 | 34.0 | 41.2 | −10.4 | 0.0003 * | 24.4 | 33.9 | −12.8 | 0.0093 * | 0.0041 * | |
| (24.3) | (22.1) | (24.1) | (22.1) | (−15.8 to −5.1) | (22.7) | (19.4) | (−22.2 to −3.3) | |||||
| Stiffness | 45.5 | 39.0 | 35.1 | 39.6 | −11.0 | 0.0001 * | 25.2 | 33.8 | −15.1 | 0.0019 * | 0.0006 * | |
| (24) | (21.7) | (24.7) | (21.6) | (−16.1 to −5.9) | (22.0) | (21.5) | (−24.4 to −5.9) | |||||
| VAS3 | Pain | 50.9 | 47.4 | 38.4 | 45.4 | −10.4 | 0.0001 * | 26.8 | 36.4 | −13.2 | 0.0105 * | 0.0046 * |
| (21.4) | (21.5) | (22.1) | (21.5) | (−15.3 to −5.6) | (20.6) | (21.4) | (−23.1 to −3.2) | |||||
| Discomfort | 50.3 | 46.8 | 37.2 | 45.6 | −11.9 | <0.0001 * | 26.2 | 36.3 | −13.6 | 0.0072 * | 0.0034 * | |
| (21.8) | (21.5) | (22.3) | (20.6) | (−16.9 to −6.9) | (18.7) | (21.8) | (−23.3 to −3.9) | |||||
| Stiffness | 48.7 | 42.4 | 36.5 | 42.0 | −11.7 | <0.0001 * | 26.5 | 34.9 | −14.7 | 0.0022 * | 0.0006 * | |
| (22.0) | (22.3) | (22.2) | (21.4) | (−16.7 to −6.8) | (18.7) | (22.6) | (−23.9 to −5.6) | |||||
| VAS4 | Pain | 37.3 | 30.4 | 25.5 | 31.6 | −13.0 | <0.0001 * | 19.2 | 26.4 | −14.1 | 0.0025 * | 0.0012 * |
| (23.1) | (19.1) | (19.9) | (22.3) | (−18.1 to −7.9) | (18.5) | (16.8) | (−23.0 to −5.2) | |||||
| Discomfort | 39.4 | 30.9 | 26.8 | 32.0 | −13.8 | <0.0001 * | 20.2 | 27.2 | −15.6 | 0.0011 * | 0.0003 * | |
| (22.8) | (22.7) | (19.9) | (24.1) | (−18.2 to −9.4) | (19.6) | (19.1) | (−24.6 to −6.5) | |||||
| Stiffness | 38.5 | 30.0 | 26.5 | 30.0 | −12.0 | <0.0001 * | 19.9 | 26.0 | −14.6 | 0.0037 * | 0.0006 * | |
| (23.8) | (21.8) | (20.4) | (22.1) | (−16.4 to −7.6) | (19.2) | (19.0) | (−24.2 to −5.0) | |||||
| VAS5 | Pain | 40.5 | 39.3 | 30.4 | 41.2 | −11.9 | <0.0001 * | 22.9 | 33.2 | −11.5 | 0.0131 * | 0.0083 * |
| (21.5) | (20.6) | (21.5) | (20.9) | (−16.4 to −7.4) | (20.1) | (19.5) | (−20.4 to −2.5) | |||||
| Discomfort | 41.3 | 39.7 | 29.3 | 41.1 | −13.3 | <0.0001 * | 22.1 | 33.6 | −13.1 | 0.0074 * | 0.0042 * | |
| (22.5) | (21.0) | (21.1) | (21.2) | (−18.5 to −8.2) | (19.1) | (20.2) | (−22.5 to −3.7) | |||||
| Stiffness | 39.1 | 37.8 | 28.4 | 39.7 | −12.6 | <0.0001 * | 21.8 | 32.7 | −12.1 | 0.0112 * | 0.0059 * | |
| (21.8) | (22.3) | (21.5) | (21.0) | (−16.6 to −8.5) | (19.1) | (20.4) | (−21.4 to −2.9) | |||||
| VAS6 | Pain | 44.9 | 44.5 | 35.8 | 44.9 | −9.5 | <0.0001 * | 26.5 | 36.3 | −10.2 | 0.0228 * | 0.0131 * |
| (22.1) | (19.3) | (20.2) | (19.6) | (−13.1 to −5.8) | (20.9) | (19.9) | (−18.9 to −1.5) | |||||
| Discomfort | 45.0 | 44.4 | 34.6 | 44.8 | −10.8 | <0.0001 * | 26.0 | 36.1 | −10.8 | 0.0166 * | 0.0101 * | |
| (22.5) | (19.9) | (20.3) | (20.2) | (−14.5 to −7.1) | (20.3) | (20.2) | (−19.5 to −2.0) | |||||
| Stiffness | 43.5 | 40.8 | 33.7 | 42.9 | −11.9 | <0.0001 * | 26.2 | 34.8 | −11.2 | 0.0128 * | 0.0088 * | |
| (23.4) | (22.0) | (20.9) | (21.2) | (−15.8 to −8.0) | (20.5) | (21.0) | (−20.0 to −2.5) | |||||
| VAS7 | Pain | 23.8 | 17.3 | 15.7 | 19.1 | −10.0 | 0.0002 * | 11.0 | 17.4 | −12.9 | 0.0005 * | 0.0001 * |
| (20.7) | (19.0) | (16.0) | (20.3) | (−14.9 to −5.0) | (12.5) | (17.4) | (−19.8 to −6.0) | |||||
| Discomfort | 24.1 | 16.2 | 15.8 | 19.5 | −11.6 | <0.0001 * | 11.5 | 17.4 | −13.8 | 0.0006 * | 0.0001 * | |
| (20.9) | (19.6) | (16.4) | (21.1) | (−16.7 to −6.5) | (12.9) | (17.8) | (−21.3 to −6.2) | |||||
| Stiffness | 23.1 | 16.0 | 15.6 | 18.7 | −10.2 | <0.0001 * | 11.6 | 17.3 | −12.8 | 0.0008 * | 0.0001 * | |
| (20.7) | (18.9) | (16.9) | (20.5) | (−14.7 to −5.8) | (12.8) | (17.7) | (−19.9 to −5.6) | |||||
| VAS8 | Pain | 45.1 | 36.3 | 31.1 | 35.2 | −12.9 | <0.0001 * | 24.3 | 30.0 | −14.6 | 0.0018 * | 0.0010 * |
| (20.8) | (21.0) | (17.9) | (20.1) | (−18.1 to −7.7) | (18.6) | (18.2) | (−23.4 to −5.7) | |||||
| Discomfort | 47.2 | 37.2 | 30.6 | 37.1 | −16.4 | <0.0001 * | 22.2 | 31.1 | −18.8 | 0.0001 * | <0.0001 * | |
| (20.5) | (21.5) | (17.3) | (19.6) | (−22.0 to −10.8) | (15.8) | (19.3) | (−27.8 to −9.9) | |||||
| Stiffness | 43.8 | 34.1 | 29.4 | 34.3 | −14.6 | <0.0001 * | 21.7 | 29.3 | −17.3 | 0.0001 * | <0.0001 * | |
| (20.8) | (21.4) | (17.0) | (20.1) | (−20.1 to −9.0) | (15.2) | (19.2) | (−25.7 to −9.0) | |||||
Data are presented as mean ± SD. 1 CI, confidence interval; LMM, linear mixed model; SD, standard deviation; W, week. The differences between the 6AA and control groups in changes from W0 to W4 and W12 were assessed by Student’s t-test * p < 0.05 between the 6AA and placebo groups. VAS scores were obtained for pain, discomfort, or stiffness experienced during eight different activities. These were as follows: VAS1, walking up stairs; VAS2, walking down stairs; VAS3, standing up from a chair; VAS4, kneeling (‘seiza’ in Japanese); VAS5, standing from seiza; VAS6, getting out of bed upon waking; VAS7, at rest before bed; and VAS8, walking a long distance or for a longer time than usual.