Table 2.
Assessment of Range of Motion Parameters at Each Study Visit
| Assessment of ROM | Baseline | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Delta change after 24 weeks | p-Value betweena groups | p-Value withinb groups |
|---|---|---|---|---|---|---|---|---|---|---|
| ROM flexion active (°) | ||||||||||
| UC-II | 127.6 (123.8–131.4) | 128.9 (125.4–132.3) | 129.7 (127.0–132.4) | 129.9 (127.2–132.6) | 130.3 (127.1–133.4) | 130.4 (127.6–133.10) | 130.8 (128.0–133.6) | 3.23 (0.44 to 6.02) | 0.025 | 0.2844 |
| PLA | 126.9 (123.9–129.9) | 126.2 (123.0–129.4) | 126.1 (122.8–129.4) | 126.8 (123.5–130.0) | 126.1 (122.3–129.8) | 127.1 (124.3–129.9) | 127.1 (123.9–130.3) | 0.21 (−1.67 to 2.08) | 0.9134 | |
| ROM flexion active (°) by gender | ||||||||||
| UC-II female | 128.4 (123.1–133.7) | 130.5 (126.1–134.9) | 131.4 (127.7–135.1) | 132.1 (128.9–135.4) | 131.8 (128.1–135.5) | 131.8 (128.8–134.9) | 133.2 (129.7–136.7) | 4.79 (1.21 to 8.36) | 0.0063 | 0.0332 |
| PLA female | 128 (123.5–132.5) | 126.8 (122.5–131.0) | 127.1 (122.3–131.9) | 128.0 (123.1–133.0) | 127.6 (122.2–133.1) | 127.9 (123.6–132.2) | 127.7 (122.9–132.6) | −0.32 (−2.85 to 2.21) | 0.9732 | |
| UC-II male | 126.4 (120.6–132.2) | 126.6 (120.7–132.4) | 127.5 (123.3–131.6) | 126.8 (122.1–131.4) | 128.1 (122.1–1340.0) | 128.3 (123.2–133.4) | 127.5 (122.9–132.0) | 1.05 (−3.60 to 5.70) | 0.7881 | 0.9465 |
| PLA male | 125.3 (121.3–129.3) | 125.4 (120.2–130.6) | 124.8 (120.1–129.5) | 125.0 (121.1–129.5) | 123.9 (118.6–129.2) | 126.0 (122.8–129.1) | 126.3 (122.4–130.1) | 0.95 (−2.07 to 3.97) | 0.8828 | |
| ROM flexion active (°) by age | ||||||||||
| UC-II age 20–35 | 130.9 (127.0–134.9) | 130.8 (127.0–134.5) | 130 (126.9–133.1) | 131.2 (128.5–134.0) | 133.1 (130.1–136.2) | 131.7 (129.0–134.3) | 131.8 (129.1–134.5) | 0.90 (−2.64 to 4.44) | 0.6012 | 0.3129 |
| PLA age 20–35 | 130.7 (127.3–134.0) | 128.2 (122.8–133.6) | 127.0 (120.5–133.4) | 129.9 (125.1–134.7) | 128.7 (122.4–135.0) | 131.0 (127.4–134.7) | 130.8 (127.1–134.4) | 0.10 (−2.32 to 2.51) | 0.2337 | |
| UC-II age >35 | 122.5 (115.1–129.8) | 125.9 (119.1–132.8) | 129.3 (123.9–134.7) | 127.8 (122.2–133.5) | 125.8 (119.1–132.3) | 128.4 (122.5–134.2) | 129.3 (123.2–135.4) | 6.79 (2.38 to 11.20) | 0.0092 | 0.0024 |
| PLA age >35 | 124 (119.4–128.5) | 124.6 (120.6–128.6) | 125.5 (121.9–129.1) | 124.3 (119.9–128.7) | 124.0 (119.2–128.8) | 124.0 (120.2–127.9) | 124.3 (119.5–129.0) | 0.30 (−2.60 to 3.19) | 0.9462 | |
| ROM flexion passive (°) | ||||||||||
| UC-II | 146.2 (142.9–149.5) | 145.7 (142.1–149.3) | 148.0 (144.6–151.4) | 146.5 (143.1–149.8) | 147.9 (143.8–152.0) | 147.7 (144.5–150.9) | 148.3 (144.4–152.3) | 2.15 (−0.71 to 5.00) | 0.3103 | 0.3167 |
| PLA | 146.4 (142.9–149.9) | 144.3 (140.3–148.2) | 144.8 (140.8–148.8) | 145.9 (142.1–149.8) | 145.6 (141.0–149.8) | 145.2 (141.0–150.2) | 146.4 (141.9–151.0) | 0.06 (−2.85 to 3.97) | 0.7695 | |
| ROM extension active (°) | ||||||||||
| UC-II | 74.2 (73.0–75.4) | n.a. | n.a. | 76.2 (74.7–77.7) | n.a. | n.a. | 76.4 (74.9–77.9) | 2.21 (0.82 to 3.60) | 0.3115 | 0.0061 |
| PLA | 74.2 (72.7–75.8) | n.a. | n.a. | 75.0 (73.4–76.6) | n.a. | n.a. | 75.5 (74.0–77.0) | 1.27 (−0.17 to 2.71) | 0.2540 | |
Values are means (upper and lower bound of 95% CI).
n = 48 in each intervention group.
a
p-Value for comparison between the groups by ANCOVA.
b
p-Value for within-group analysis by repeated-measures ANOVA or Freidman test as appropriate.
ANCOVA, analysis of covariance; ANOVA, analysis of variance; CI, confidence interval; n.a., not applicable; PLA, placebo; ROM, range of motion; UC-II, Undenaturated type II collagen.