Outcome Measures | Diabetic (n = 41) Mean + SD (95%CI) | Control (n = 41) Mean + SD (95%CI) | Main effect of time (p) | Main effect of group (p) | Group × time interaction (p) |
---|---|---|---|---|---|
Primary Outcomes | |||||
NRS leg/10 | |||||
Baseline | 6.2 ± 1.9 (5.9-7.0) | 6.3 ± 2.1 (6.4–7.3) | |||
6 weeks | 5.0 ± 1.7 (4.4–5.6) | 4.2 ± 1.6 (3.6–4.6) | < 0.001 | 0.023 | < 0.001 |
12 weeks | 4.6 ± 1.9 (4.1–5.3) | 3.7 ± 1.6 (3.0–4.0) | |||
ODI /100 | |||||
Baseline | 35.2 ± 12.1 (32.9–41.4) | 35.7 ± 13.9 (31.9–41.0) | |||
6 weeks | 33.5 ± 10.2 (33.1–38.6) | 34.6 ± 15.5 (29.4–38.6) | 0.010 | 0.397 | 0.774 |
12 weeks | 31.6 ± 9.9 (29.3–36.7) | 33.0 ± 15.3 (27.8–36.8) | |||
Second Outcomes | |||||
NRS back/10 | |||||
Baseline | 3.9 ± 1.8 (3.3–4.6) | 3.8 ± 1.2 (2.8–3.7) | 0.031 | 0.155 | 0.122 |
6 weeks | 2.9 ± 1.7 (2.3–3.4) | 2.2 ± 1.2 (1.8–2.6) | |||
12 weeks | 2.3 ± 1.2 (1.9–2.7) | 1.9 ± 1.0 (1.6–2.2) | |||
SPWT | |||||
Baseline | 464.4 ± 221.4 (379.6–537.0) | 462.1 ± 268.1 (351.3-529.7) | |||
6 weeks | 545.3 ± 178.2 (478.0-612.7) | 651.4 ± 246.0 (544.0-706.3) | < 0.001 | 0.042 | 0.027 |
12 weeks | 612.7 ± 189.1 (552.3-682.3) | 776.5 ± 269.3 (642.1-823.8) | |||
SF-36 BP /100 | |||||
Baseline | 42.1 ± 13.0 (38.1–46.5) | 42.2 ± 15.8 (37.6–48) | |||
6 weeks | 47.6 ± 12.2 (43.8–51.5) | 48.2 ± 16.0 (43.2–53.3) | 0.363 | 0.134 | 0.291 |
12 weeks | 49.4 ± 11.6 (45.7–53.1) | 52.5 ± 16.2 (47.4–57.6) | |||
SF-36 PF/100 | |||||
Baseline | 45.2 ± 12.8 (40.1–48.6) | 46.3 ± 14.9 (42.8–52.0) | |||
6 weeks | 47.1 ± 13.8 (42.7–51.4) | 50.0 ± 14.7 (45.3–54.6) | 0.247 | 0.182 | 0.121 |
12 weeks | 49.9 ± 13.5 (45.7–54.2) | 53.7 ± 15.3 (48.9–58.6) | |||
SBI/24 | |||||
Baseline | 12.4 ± 4.1 (11.2–12.9) | 11.5 ± 4.2 (10.4–13.2) | |||
6 weeks | 9.5 ± 3.8 (8.3–0.7) | 8.7 ± 4.7 (7.3–10.2) | 0.032 | 0.098 | 0.166 |
12 weeks | 8.0 ± 3.8 (6.8–9.2) | 6.7 ± 3.3 (5.7–7.8) | |||
TSK-11/68 | |||||
Baseline | 44.2 ± 9.2 (40.7–46.0) | 44.8 ± 14.2 (37.7–45) | |||
6 weeks | 41.0 ± 7.8 (38.5–43.4) | 38.3 ± 11.9 (34.6–42.1) | 0.128 | 0.144 | 0.453 |
12 weeks | 39.6 ± 7.7 (37.2–42.0) | 36.8 ± 12.7 (32.8–40.8) | |||
BDI/63 | |||||
Baseline | 7.2 ± 3.6 (6.3–8.7) | 7.0 ± 4.3 (4.6 to 7.2) | |||
6 weeks | 5.9 ± 4.0 (4.5–6.9) | 5.7 ± 4.3 (4.1 to 6.3) | 0.087 | 0.106 | 0.051 |
12 weeks | 5.3 ± 3.6 (4.3–6.6) | 5.0 ± 3.9 (3.8 to 6.2) |