Henrotin et al. BMC Musculoskeletal Disorders
(2022) 23:650
Page 6 of 11
Table 1 (continued)
Placebo ( N = 68) 200 mg ( N = 66)
400 mg ( N = .64)
All ( N = 198)
P -values
SPPB
n/n miss
68/0
66/0
64/0
198/0
0.26
Mean (SEM)
10.50 (0.15)
10.36 (0.15)
10.70 (0.14)
10.52 (0.08)
Median
11.00
10.00
11.00
11.00
Min, Max n/n miss
8.0,12.0
6.0, 12.0
9.0, 12.00
6.0, 12.0
IPAQ
64/4
63/3
64/0
193/7
0.71
Mean (SEM)
2711.58 (400.61)
2996.67 (509.16) 3251.88 (472.38) 2986.66 (266.05)
Median Min, Max
1623.00
1332.00
1721.50
1428.00
99.0, 19,640.0
0.0, 23,640.0
198.00,17,695.0 0.0, 23,640.0
BMI Body Mass Index, WOMAC Western Ontarion McMaster osteoarthritis index, VAS Visual analog scale, SF-36 Short Form (36), SPPB Short Physical Performance Battery, IPAQ International Physical Activity Questionnaire. Baseline differences assessed by one-way-analysis-of variance for continuous data, and Pearson’s Chi Square for categorical data
participants (9%) had a Kellgren-Lawrence score of 3. No significant differences were observed between the three treatment groups according to demographic character- istics and BMI. Fifty-one participants had a BMI < 25 kg/ m2 and 147 had a BMI ≥ 25. At baseline, global WOMAC and subscores, VAS pain, SF-36, SPPB, and IPAQ scores were not significantly different between BMI groups (Additional file 2). Clinical outcomes In ITT population, WOMAC pain (in mean (SEM) at baseline: 4.89 (0.21)) significantly decreased over time in all groups ( p < 0.0001). However, there was no differ- ence between treatments. RIE 200 mg and 400 mg after
12 weeks of treatment reduced pain measured by the VAS respectively of -8.51 (1.92) mm and -10.93 (1.95) mm compared to baseline, while the placebo group had a -3.84 (1.89) mm reduction. This means pain reduc- tion induced by RIE reached a statistical difference com- pared to placebo at the highest dose (-7.09 (2.71); 95% CI, -13.11 to -1.07; p = 0,017) (Fig. 2, Table 2). At the daily dosage of 200 mg or 400 mg, the effect size calculated on the VAS pain score of the ITT population was 0.30 and 0.45 after 12 weeks, respectively. After 12 weeks of treatment, a subgroup analysis of the participants with a BMI ≥ 25, highlighted VAS pain reduction for the 200 and 400 mg doses compared to baseline of respectively -11.25 (2.14) mm and -13.36
Fig. 2 Time evolution of the VAS pain score in ITT population. * = significant effect of RIE 400 mg compared to placebo
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