Table 4.
Additional outcomes comparing the IA-BoNT/A and IA-placebo groups using generalized estimating equations (GEE) analyses. Data are mean (SD).
| Baseline Preinjection |
2 Weeks | 1 Month | 2 Months | 3 Months | 4 Months | p (repeated measures analyses*†) |
|
|---|---|---|---|---|---|---|---|
| Mean VAS pain (0–10) | 0.09 | ||||||
| IA-BoNT/A | 7.2 (1.1) | NA | NA | 4.4 (2.5) | 4.2 (2.6) | 4.8 (2.4) | |
| IA-placebo | 7.5 (1.3) | NA | NA | 5.7 (2.9) | 5.2 (3.2) | 5.0 (2.6) | |
| Secondary outcomes | |||||||
| WOMAC physical function (0–100) | |||||||
| IA-BoNT/A | 56.5 (8.9) | 48.3 (13.1) | 47.8 (14.7) | 48.5 (14.4) | 46.8 (16.6) | 45.9 (17.9) | 0.03 |
| IA-placebo | 63.3 (17.5) | 60.9 (16.0) | 57.7 (18.8) | 59.7 (17.4) | 52.9 (21.1) | 57.1 (17.4) | |
| WOMAC stiffness (0–100) | |||||||
| IA-BoNT/A | 64.1 (20.4) | 44.3 (24.9) | 49.4 (20.9) | 51.8 (19.1) | 50.0 (19.7) | 47.4 (25.5) | < 0.01 |
| IA-placebo | 64.4 (18.9) | 63.7 (18.1) | 48.9 (26.1) | 60.4 (16.3) | 57.7 (23.5) | 59.9 (22.7) | |
| WOMAC pain (0–100) | |||||||
| IA-BoNT/A | 58.0 (13.6) | 40.0 (16.9) | 49.5 (18.1) | 45.2 (22.3) | 43.6 (20.1) | 42.6 (20.1) | 0.12 |
| IA-placebo | 67.1 (15.3) | 54.7 (19.7) | 57.0 (17.6) | 58.3 (14.7) | 51.2 (22.7) | 51.6 (20.9) | |
| WOMAC total (0–100) | |||||||
| IA-BoNT/A | 63.2 (9.3) | 50.9 (15.2) | 53.1 (16.2) | 52.9 (15.5) | 51.0 (17.8) | 49.9 (18.3) | 0.02 |
| IA-placebo | 70.6 (16.8) | 65.9 (17.7) | 62.5 (19.1) | 65.5 (17.0) | 58.3 (22.3) | 61.8 (18.9) | |
| Timed Stands Test | |||||||
| IA-BoNT/A | 49.9 (31.4) | NA | NA | 37.4 (15.8) | 35.5 (13.9) | 37.6 (15.7) | 0.98 |
| IA-placebo | 50.8 (29.3) | NA | NA | 42.1 (22.5) | 39.3 (22.1) | 38.9 (13.0) | |
| Timed Up and Go Test | |||||||
| IA-BoNT/A | 18.3 (13.8) | NA | NA | 17.2 (9.6) | 17.6 (13.2) | 14.8 (5.9) | 0.14 |
| IA-placebo | 18.5 (12.7) | NA | NA | 18.2 (13.8) | 15.5 (10.5) | 18.2 (16.3) | |
| Active flexion | |||||||
| IA-BoNT/A | 83.3 (22.5) | NA | NA | 75.0 (20.8) | 74.7 (23.0) | 79.3 (23.0) | 0.23 |
| IA-placebo | 86.2 (16.7) | NA | NA | 87.5 (15.3) | 85.6 (12.5) | 83.1 (15.4) | |
| Active extension | |||||||
| IA-BoNT/A | 170.7 (10.9) | NA | NA | 170.0 (18.0) | 169.7 (13.1) | 157.8 (44.4) | 0.86 |
| IA-placebo | 167.8 (10.0) | NA | NA | 170.5 (7.4) | 163.2 (40.2) | 163.7 (38.0) | |
| McGill affective dimension | |||||||
| IA-BoNT/A | 6.1 (2.8) | NA | 4.5 (3.1) | 3.8 (3.1) | 3.8 (3.1) | 3.9 (3.1) | 0.08 |
| IA-placebo | 5.3 (3.1) | NA | 4.1 (3.5) | 4.8 (3.4) | 4.8 (3.4) | 4.8 (3.3) | |
| McGill sensory dimension | |||||||
| IA-BoNT/A | 16.7 (6.5) | NA | 14.5 (8.3) | 14.5 (8.0) | 11.6 (6.3) | 12.9 (8.1) | 0.73 |
| IA-placebo | 17.3 (6.8) | NA | 13.4 (5.8) | 14.6 (7.5) | 11.7 (7.3) | 13.5 (8.4) | |
| McGill total | |||||||
| IA-BoNT/A | 23.8 (8.3) | NA | 19.0 (10.8) | 18.3 (10.1) | 15.4 (8.1) | 16.8 (10.8) | 0.42 |
| IA-placebo | 22.7 (8.8) | NA | 17.5 (8.4) | 19.4 (10.3) | 16.7 (9.8) | 18.3 (11.2) | |
| SF-36 subscales | |||||||
| Bodily pain†† | |||||||
| IA-BoNT/A | 28.5 (17.0) | NA | NA | 46.5 (19.0) | 42.9 (20.1) | 43.9 (22.7) | 0.049 |
| IA-placebo | 29.0 (13.7) | NA | NA | 36.4 (17.4) | 37.0 (23.3) | 39.1 (24.5) | |
| Physical functioning | |||||||
| IA-BoNT/A | 29.4 (21.3) | NA | NA | 30.7 (21.8) | 29.3 (15.1) | 30.5 (19.6) | 0.68 |
| IA-placebo | 20.6 (16.0) | NA | NA | 23.6 (17.5) | 25.2 (20.0) | 22.6 (18.8) | |
| Role physical | |||||||
| IA-BoNT/A | 12.0 (21.1) | NA | NA | 22.7 (29.8) | 26.1 (34.0) | 26.3 (30.9) | 0.74 |
| IA-placebo | 13.5 (23.7) | NA | NA | 18.0 (26.5) | 28.1 (32.4) | 29.8 (35.0) | |
| Role emotional | |||||||
| IA-BoNT/A | 49.3 (47.0) | NA | NA | 45.4 (40.6) | 56.1 (47.6) | 46.7 (43.8) | 0.08 |
| IA-placebo | 48.7 (49.2) | NA | NA | 61.3 (45.8) | 68.1 (42.3) | 63.5 (43.3) | |
| Mental health | |||||||
| IA-BoNT/A | 69.6 (17.1) | NA | NA | 67.8 (21.4) | 68.6 (17.8) | 68.6 (20.9) | 0.31 |
| IA-placebo | 64.0 (20.3) | NA | NA | 67.5 (21.7) | 70.7 (26.1) | 69.5 (20.1) | |
| Social functioning | |||||||
| IA-BoNT/A | 55.4 (26.1) | NA | NA | 64.8 (26.3) | 60.2 (26.9) | 60.6 (25.1) | 0.99 |
| IA-placebo | 50.5 (29.3) | NA | NA | 61.5 (27.7) | 62.0 (31.8) | 58.9 (37.3) | |
| General health | |||||||
| IA-BoNT/A | 52.9 (20.7) | NA | NA | 55.0 (20.4) | 49.3 (20.4) | 49.5 (24.4) | 0.98 |
| IA-placebo | 55.1 (24.4) | NA | NA | 51.8 (21.7) | 52.1 (21.6) | 53.2 (21.7) | |
| Vitality | |||||||
| IA-BoNT/A | 42.6 (17.8) | NA | NA | 41.6 (19.5) | 46.4 (15.6) | 45.0 (23.5) | 0.98 |
| IA-placebo | 40.0 (24.6) | NA | NA | 41.2 (24.3) | 44.4 (28.9) | 43.6 (27.9) | |
Comparison of IA-BoNT/A and placebo for all efficacy timepoints up to 4 months using GEE, adjusting for respective baseline scores.
Sensitivity analyses that included bilateral total knee arthroplasty (TKA) did not change the significance for any variable listed above (data not shown), except SF-36 pain, for which p value was 0.14 when all 60 TKA were included.
Only the SF-36 bodily pain subscale score was significantly different between groups; no other SF-36 subscale scores were significantly different between groups at 2 months.
WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index; SF-36: Short-form 36; NA: not applicable since these variables were not assessed at these telephone followup visits.