Table 2. Results of the Linear Mixed Models With Repeated Measurements for Between-Group Differences Regarding Secondary Outcomes Based on Per-Protocol Analysis.
| Variable | Mean (SD)a | Mean difference (95% CI)b | P valuec | Effect size | |
|---|---|---|---|---|---|
| IM (n = 72) | IA (n = 66) | ||||
| KOOS d | |||||
| Symptoms | |||||
| 2 wk | 64.3 (15.4) | 69.0 (17.2) | −3.0 (−8.7 to 2.8) | .31 | −0.18 |
| 4 wk | 65.9 (17.4) | 70.1 (17.8) | −2.6 (−8.8 to 3.6) | .40 | −0.15 |
| 8 wk | 68.0 (17.9) | 66.0 (18.0) | 1.4 (−5.2 to 7.9) | .68 | 0.08 |
| 12 wk | 64.3 (18.9) | 65.0 (19.7) | −0.2 (−6.9 to 6.5) | .95 | −0.01 |
| 24 wk | 63.4 (20.3) | 62.7 (20.0) | 1.7 (−5.3 to 8.7) | .63 | 0.08 |
| Function | |||||
| 2 wk | 63.3 (20.5) | 67.6 (21.9) | −1.7 (−9.0 to 5.6) | .65 | −0.08 |
| 4 wk | 64.2 (20.9) | 67.7 (20.1) | −1.6 (−8.8 to 5.6) | .66 | −0.08 |
| 8 wk | 67.8 (21.2) | 64.7 (22.1) | 3.1 (−4.5 to 10.8) | .42 | 0.14 |
| 12 wk | 63.3 (22.6) | 64.3 (21.1) | −0.4 (−7.9 to 7.1) | .92 | −0.02 |
| 24 wk | 60.6 (22.7) | 60.0 (22.7) | 3.0 (−4.8 to 10.9) | .45 | 0.13 |
| Sport and recreation | |||||
| 2 wk | 26.3 (22.5) | 27.9 (26.5) | 0.4 (−8.2 to 9.0) | .92 | 0.02 |
| 4 wk | 26.1 (22.5) | 30.4 (26.3) | −3.0 (−11.4 to 5.5) | .49 | −0.12 |
| 8 wk | 30.7 (23.3) | 27.2 (24.2) | 4.4 (−3.9 to 12.7) | .30 | 0.18 |
| 12 wk | 29.0 (24.7) | 25.3 (25.4) | 4.2 (−4.5 to 12.8) | .35 | 0.16 |
| 24 wk | 23.5 (22.5) | 24.2 (27.3) | 0.9 (−7.9 to 9.6) | .84 | 0.04 |
| Quality of life | |||||
| 2 wk | 39.6 (17.5) | 42.7 (20.4) | 0.4 (−6.1 to 7.0) | .89 | 0.02 |
| 4 wk | 40.1 (19.5) | 44.9 (20.4) | −1.4 (−8.2 to 5.5) | .69 | −0.07 |
| 8 wk | 44.5 (19.8) | 45.1 (21.6) | 1.4 (−5.7 to 8.5) | .70 | 0.07 |
| 12 wk | 41.8 (20.7) | 45.3 (21.5) | −1.1 (−8.2 to 6.0) | .76 | −0.05 |
| 24 wk | 39.3 (20.5) | 41.0 (19.7) | 0.9 (−5.9 to 7.7) | .79 | 0.04 |
| WOMAC e | |||||
| Pain | |||||
| 2 wk | 35.3 (20.8) | 30.2 (21.7) | 3.1 (−4.4 to 10.6) | .41 | 0.14 |
| 4 wk | 33.9 (20.8) | 29.8 (20.1) | 2.9 (−4.3 to 10.1) | .43 | 0.14 |
| 8 wk | 30.7 (21.0) | 32.5 (20.4) | −1.4 (−8.8 to 6.0) | .70 | −0.07 |
| 12 wk | 35.2 (21.7) | 33.0 (22.5) | 1.6 (−6.1 to 9.2) | .69 | 0.07 |
| 24 wk | 38.0 (22.4) | 37.8 (22.3) | −1.1 (−8.9 to 6.6) | .77 | −0.05 |
| Function | |||||
| 2 wk | 36.7 (20.5) | 32.4 (21.8) | 1.7 (−5.6 to 9.0) | .65 | 0.08 |
| 4 wk | 35.8 (20.9) | 32.3 (20.1) | 1.6 (−5.6 to 8.8) | .66 | 0.08 |
| 8 wk | 32.2 (21.2) | 35.3 (22.1) | −3.1 (−10.8 to 4.5) | .42 | −0.14 |
| 12 wk | 37.7 (22.6) | 35.7 (21.1) | 0.4 (−7.1 to 7.9) | .92 | 0.02 |
| 24 wk | 39.3 (22.7) | 40.0 (22.7) | −3.0 (−10.9 to 4.8) | .45 | −0.13 |
| Stiffness | |||||
| 2 wk | 44.7 (18.7) | 41.0 (22.5) | 2.3 (−5.0 to 9.6) | .53 | 0.11 |
| 4 wk | 41.8 (21.7) | 38.2 (23.5) | 2.4 (−5.5 to 10.3) | .55 | 0.10 |
| 8 wk | 39.6 (23.5) | 43.4 (23.6) | −3.1 (−11.5 to 5.3) | .47 | −0.13 |
| 12 wk | 44.0 (23.5) | 44.8 (23.9) | −0.9 (−9.2 to 7.3) | .83 | −0.04 |
| 24 wk | 45.3 (24.3) | 49.2 (23.9) | −5.0 (−13.3 to 3.3) | .24 | −0.21 |
| Total | |||||
| 2 wk | 37.1 (19.8) | 32.6 (21.1) | 2.0 (−5.1 to 9.1) | .57 | 0.10 |
| 4 wk | 35.9 (20.2) | 32.3 (19.4) | 2.0 (−5.0 to 9.0) | .57 | 0.10 |
| 8 wk | 32.5 (20.5) | 35.4 (21.1) | −2.7 (−10.1 to 4.7) | .47 | −0.13 |
| 12 wk | 37.7 (21.7) | 35.9 (20.7) | 0.6 (−6.7 to 7.8) | .87 | 0.03 |
| 24 wk | 39.6 (21.9) | 40.3 (21.9) | −2.8 (−10.4 to 4.8) | .47 | −0.13 |
| NRS pain f | |||||
| 2 wk | 4.8 (2.2) | 4.4 (2.6) | 0.3 (−0.5 to 1.1) | .45 | 0.13 |
| 4 wk | 5.0 (2.3) | 4.3 (2.3) | 0.6 (−0.2 to 1.4) | .11 | 0.26 |
| 8 wk | 4.5 (2.3) | 5.1 (2.4) | −0.6 (−1.4 to 0.3) | .12 | −0.26 |
| 12 wk | 5.2 (2.2) | 5.0 (2.5) | 0.3 (−0.5 to 1.1) | .52 | 0.13 |
| 24 wk | 5.6 (2.2) | 5.6 (2.3) | −0.02 (−0.8 to 0.8) | .96 | −0.01 |
| ICOAP g | |||||
| Constant pain | |||||
| 2 wk | 29.6 (21.8) | 23.3 (22.7) | 4.5 (−3.3 to 12.3) | .26 | 0.20 |
| 4 wk | 31.2 (23.1) | 25.8 (21.5) | 4.3 (−3.6 to 12.1) | .29 | 0.19 |
| 8 wk | 28.0 (23.3) | 29.1 (22.5) | −0.5 (−8.8 to 7.9) | .91 | −0.02 |
| 12 wk | 33.1 (22.1) | 29.2 (23.0) | 4.3 (−3.7 to 12.3) | .29 | 0.19 |
| 24 wk | 33.1 (22.6) | 32.5 (23.1) | 0.1 (−8.1 to 8.3) | .98 | 0.004 |
| Intermittent pain | |||||
| 2 wk | 34.3 (21.3) | 26.3 (21.9) | 5.2 (−2.3 to 12.8) | .17 | 0.24 |
| 4 wk | 36.2 (20.7) | 30.3 (21.7) | 4.1 (−3.4 to 11.5) | .28 | 0.19 |
| 8 wk | 33.5 (21.9) | 32.8 (20.5) | 0.3 (−7.3 to 7.9) | .93 | 0.01 |
| 12 wk | 35.8 (21.7) | 32.6 (24.1) | 2.6 (−5.4 to 10.7) | .52 | 0.11 |
| 24 wk | 38.4 (20.3) | 36.2 (22.8) | 1.0 (−6.6 to 8.7) | .79 | 0.05 |
| Total score | |||||
| 2 wk | 32.1 (20.8) | 25.0 (21.6) | 5.0 (−2.4 to 12.4) | .19 | 0.23 |
| 4 wk | 34.0 (21.0) | 28.2 (21.1) | 4.2 (−3.2 to 11.6) | .26 | 0.20 |
| 8 wk | 31.0 (21.9) | 31.1 (20.9) | 0.04 (−7.7 to 7.8) | .99 | 0.002 |
| 12 wk | 34.6 (20.9) | 31.0 (23.3) | 3.5 (−4.3 to 11.3) | .37 | 0.16 |
| 24 wk | 36.0 (20.3) | 34.5 (22.3) | 0.7 (−7.0 to 8.3) | .87 | 0.03 |
| EQ-5D-5L h | |||||
| 4 wk | 0.67 (0.26) | 0.74 (0.21) | −0.03 (−0.12 to 0.05) | .42 | −0.12 |
| 24 wk | 0.67 (0.27) | 0.68 (0.25) | 0.02 (−0.07 to 0.11) | .65 | 0.08 |
Abbreviations: EQ-5D-5L, EuroQol with 5 dimensions and 5 response levels; IA, intra-articular; ICOAP, intermittent and constant osteoarthritis pain; IM, intramuscular; KOOS, Knee Injury and Osteoarthritis Outcome Score; NRS, numeric rating scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.
a
Observed means and SDs, unadjusted values. There were no missing values in the model covariates, and all patients (138) were included in modeling.
b
Intra-articular injection as reference, adjusted for baseline score, sex, presence of depression, and duration of knee osteoarthritis symptoms. Calculated based on estimated marginal means.
c
P values for superiority tests.
d
Score range, 0 to 100; 0 indicates extreme symptoms.
e
Score range, 0 to 100; 0 indicates no symptoms.
f
Score range, 0 to 10; 0 indicates no pain.
g
Score range, 0 to 100; 0 indicates no pain.
h
Score range, −0.446 to 1.000; −0.446 indicates worst health-related quality of life.