Table 1.
Baseline characteristics of patients in both groups
| Characteristic | DETP (n = 68) | Placebo (n = 66) | P valuea |
|---|---|---|---|
| Age, mean (SD) | 33.3 (13.9) | 29.7 (11.6) | 0.1 |
| Gender: male/female | 33/35 | 39/27 | 0.2 |
| Weight: mean (SD) | |||
| Males | 75.4 (11.0) | 77.7 (19.2) | 0.5 |
| Females | 62.8 (12.6) | 57.1 (9.2) | 0.05 |
| Body mass index, mean (SD) | |||
| Males | 23.9 (3.3) | 24.8 (5.6) | 0.5 |
| Females | 23.6 (5.1) | 21.1 (3.0) | 0.05 |
| Ice application | |||
| No (%) | 43 (63.2) | 39 (59.1) | 0.6 |
| Yes (%) | 25 (36.8) | 27 (40.9) | 0.6 |
| Enrollment delay: mean (hours) | 17.3 | 19.9 | 0.4 |
| Injured ankle periarticular edema (mm) | |||
| Mean (SD) | 254 (27) | 253 (29) | |
| Median (minimum-maximum) | 256 (150–300) | 260 (127–302) | 0.9 |
| VAS self-evaluation (patient) | |||
| Mean (SD) | 66.9 (10.6) | 70.0 (11.8) | |
| Median (minimum-maximum) | 66.0 (50–92) | 67.5 (50–100) | 0.2 |
| Pain at rest (clinician) | |||
| None/low/moderate/high | 10/32/24/2 | 11/28/23/4 | 0.8 |
| Pain on passive stretch (clinician) | |||
| None/low/moderate/high | 0/4/36/28 | 0/4/29/33 | 0.4 |
| Pain on palpation (clinician) | |||
| None/low/moderate/high | 0/0/23/45 | 0/2/21/43 | 0.7 |
| Single foot leaning (patient) | |||
| Okay without pain/okay with pain/impossible | 4/52/12 | 6/44/16 | 0.5 |
Note:
a
Fisher’s exact test of heterogeneity for dichotomous variables and Wilcoxon nonparametric test for quantitative variables.
Abbreviations: DETP, diclofenac epolamine topical patch; n, number of patients; SD, standard deviation; VAS, visual analog scale.