Table 3.
Secondary outcome measures, Western Ontario McMaster Osteoarthritis Questionnaire (WOMAC), and range of motion (ROM) and muscle strength measurements
| Secondary outcome measurements | |||||||
|---|---|---|---|---|---|---|---|
| Variable | Baseline | Endpoint | Endpoint group difference | ||||
| Active | Placebo | p | Active | Placebo | Mean 95% CI | p | |
| WOMAC Assessment | |||||||
| n | 55 | 35 | 51 | 31 | |||
| WOMAC pain | 292 ± 89.1 | 276.5 ± 77.9 | 0.40 | 185 ± 103.2 | 215.7 ± 81.5 | − 30.4 | 0.150 |
| − 72.4 to 11.6 | |||||||
| WOMAC pain mean change from baseline 95%CI | − 107.3 ± 97.5 | − 60.8 ± 80.95 | − 46.5 − 85.6 to − 7.4 |
0.020 | |||
| − 147.6 to − 66.8 | − 100.3 to − 21.2 | ||||||
| p < 0.0001 | p = 0.003 | ||||||
| WOMAC stiffness | 125 ± 35.8 | 123.5 ± 42.7 | 0.85 | 80.2 ± 41.1 | 106.4 ± 31.1 | − 26.2 − 43.1 to 9.3 |
0.003 |
| WOMAC stiffness mean change from baseline 95%CI | − 45 ± 39.0 | − 17.1 ± 38.5 | − 27.9 − 45.1 to − 10.7 |
0.002 | |||
| − 61.1 to − 28.9 | − 36.0 to 1.9 | ||||||
| p < 0.0001 | p = 0.080 | ||||||
| WOMAC function | 975 ± 272.2 | 974 ± 218.3 | 0.99 | 622.9 ± 336.7 | 754.8 ± 241.4 | − 131.9 − 263.2 to 0.7 |
0.049 |
| WOMAC function mean change from baseline 95%CI | − 352.3 ± 309.6 | − 220.1 ± 233.6 | − 132.2 − 250.5 to − 13.9 |
0.029 | |||
| − 480.7 to − 224 | − 334.3 to − 105.9 | ||||||
| p < 0.0001 | p = 0.0002 | ||||||
| WOMAC total | 1393 ± 377 | 1375 ± 299.4 | 0.81 | 888.4 ± 471 | 1063.7 ± 351.7 | − 175.3 − 362.1 to 11.5 |
0.066 |
| WOMAC total mean change from baseline 95%CI | − 504.6 ± 431.5 | − 311.2 ± 331.33 | −193.4 − 359.6 to − 27.2 |
0.023 | |||
| − 683.4 to − 325.7 | − 473.4 to − 148.9 | ||||||
| p < 0.0001 | p = 0.0002 | ||||||
| ROM and strength assessments | |||||||
| n | 9 | 8 | 9 | 8 | |||
| ROM flexion (°) | 41.5 ± 35.0 | 36.8 ± 28.5 | 0.76 | 35.1 ± 27.9 | 34.6 ± 25.1 | 0.570 − 27.1 to 28.2 |
0.97 |
| ROM flexion mean change from baseline 95% CI | − 6.38 ± 33.6 | − 2.22 ± 38.2 | − 4.16 − 6.38 to − 2.22 |
0.79 | |||
| − 40.5 to 27.8 | − 29.1 to 24.6 | ||||||
| p = 0.69 | p = 0.86 | ||||||
| ROM extension (°) | 39.5 ± 35.9 | 37.1 ± 29.5 | 0.88 | 21.8 ± 28.0 | 31.6 ± 25.7 | −9.81 −37.8 to 18.2 |
0.46 |
| ROM extension mean change from baseline 95% CI | − 17.75 ± 34.1 | − 5.56 ± 29.34 | − 12.19 − 46.0 to 21.7 |
0.45 | |||
| − 52.5 to 17.0 | − 33.2 to 22.1 | ||||||
| p = 0.29 | p = 0.68 | ||||||
| Strength flexion (N) | 8.05 ± 3.64 | 10.4 ± 6.31 | 0.37 | 9.39 ± 2.92 | 11.4 ± 2.84 | − 2.03 − 5.03 to 0.960 |
0.17 |
| Strength flexion mean change from baseline 95% CI | 1.34 ± 3.50 | 1.01 ± 5.19 | 0.33 − 5.26 to 5.92 |
0.90 | |||
| − 2.22 to 4.89 | − 4.06 to 6.08 | ||||||
| p = 0.43 | p = 0.67 | ||||||
| Strength rotation (N) | 6.06 ± 2.22 | 9.91 ± 5.52 | 0.086 | 9.28 ± 3.10 | 10.6 ± 3.09 | − 1.31 − 4.52 to 1.90 |
0.40 |
| Strength rotation mean change from baseline 95% CI | 3.21 ± 2.86 | 0.68 ± 4.74 | 2.53 − 2.20 to 7.25 |
0.25 | |||
| 0.294 to 6.06 | − 3.89 to 5.25 | ||||||
| p = 0.03 | p = 0.75 | ||||||
| Strength extension (N) | 7.79 ± 4.36 | 9.4 ± 5.29 | 0.51 | 9.70 ± 4.83 | 11.0 ± 2.81 | − 1.30 − 5.59 to 2.99 |
0.50 |
| Strength extension mean change from baseline 95% CI | 1.91 ± 4.88 | 1.60 ± 4.49 | 0.31 − 4.78 to 5.40 |
0.90 | |||
| − 3.03 to 6.85 | − 2.74 to 5.94 | ||||||
| p = 0.42 | p = 0.43 | ||||||
p < 0.05 shown in italics