Results of patients with rheumatoid arthritis enrolled in the 2 arms of the Re.Mo.To. clinical trial. Data are mean (± SD) unless otherwise indicated.
| Experimental Arm | Control Arm | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Variables | Baseline (T0) | Week 6 (T1) | Week 12 (T2) | Change Over Time, pa | Baseline (T0) | Week 6 (T1) | Week 12 (T2) | Change Over Time, pa | Cases vs Controls, pb | Interaction Effect, pb |
| General data | ||||||||||
| Age, yrs | 56.3 (± 10.3) | — | — | 56.8 (± 12.3) | — | — | ||||
| Sex | 9F:1M | — | — | 9F:1M | — | — | ||||
| Disease duration, yrs | 13.1 (± 10.0) | — | — | 12.8 (± 10.5) | — | — | ||||
| Dominant hand | 10 right | 10 right | ||||||||
| DAS28 | 1.8 (± 0.9) | 1.4 (± 0.81) | 1.4 (± 0.74) | 0.018 | 2.0 (± 1.0) | 2.0 (± 1.0) | 2.0 (± 1.1) | 0.875 | 0.270 | 0.247 |
| Primary outcomes | ||||||||||
| HAQ | 1.22 (± 0.72) | 0.89 (± 0.72) | 0.68 (± 0.72)§ | 0.015 | 1.39 (± 0.74) | 1.38 (± 0.88) | 1.27 (± 1.01) | 0.085 | 0.178 | 0.881 |
| Dreiser’s Index | 16.3 (± 6.2) | 11.0 (± 4.4) | 9.9 (± 5.1)§ | 0.013 | 15.7 (± 6.0) | 10.7 (± 6.9)° | 13.1 (± 10.1) | 0.143 | 0.560 | 0.454 |
| Secondary outcomes | ||||||||||
| Hand abduction R, cm | 6.5 (± 2.2) | 7.0 (± 1.5) | 7.1 (± 1.1) | 0.374 | 6.5 (± 2.13) | 7.7 (± 1.4) | 7.7 (± 1.1) | 0.079 | 0.521 | 0.611 |
| Hand abduction L, cm | 7.5 (± 1.5) | 7.9 (± 0.9) | 8.5 (± 1.2) | 0.108 | 7.1 (± 2.22) | 7.7 (± 1.7) | 8.1 (± 1.4) | 0.309 | 0.603 | 0.820 |
| Hand grip R, mmHg | 59.1 (± 29.4) | 77.2 (± 31.8) | 92.0 (± 36.6)§ | 0.005 | 41.9 (± 26.8)° | 63.6 (± 34.2) | 66.1 (± 37.3) | 0.005 | 0.235 | 0.532 |
| Hand grip L, mmHg | 56.7 (± 32.2)° | 74.8 (± 25.2) | 87.4 (± 34.3)§§ | < 0.001 | 44.3 (± 30.9)° | 62.9 (± 32.5) | 54.3 (± 20.9) | 0.240 | 0.197 | 0.133 |
| Hand pinch R, mmHg | 47.8 (± 21.4) | 55.0 (± 13.1)* | 68.3 (± 18.5)§ | 0.005 | 25.0 (± 13.7) | 39.3 (± 21.1) | 45.7 (± 16.9) | 0.112 | 0.013 | 0.628 |
| Hand pinch L, mmHg | 46.1 (± 23.6) | 53.9 (± 14.3)* | 67.8 (± 19.2)§§ | < 0.001 | 25.0 (± 17.6) | 37.9 (± 17.3) | 39.9 (± 16.7) | 0.256 | 0.009 | 0.438 |
| ROM MP joint R, degrees | 85.9 (± 11.9) | 89.7 (± 11.0)* | 95.0 (± 8.9)§§ | < 0 .001 | 71.4 (± 24.7) | 93.6 (± 27.3) | 89.9 (± 16.7) | 0.044 | 0.524 | 0.063 |
| ROM MP joint L, degrees | 93.7 (± 9.5) | 95.8 (± 3.7)* | 98.9 (± 4.2) | 0.083 | 77.1 (± 16.3)° | 95.7 (± 14.0) | 95.7 (± 14.8)§ | 0.008 | 0.193 | 0.008 |
| Quality of life outcomes | ||||||||||
| VAS pain, mm | 41.5 (± 23.5) | 25.4 (± 23.4) | 24.0 (± 18.9) | 0.247 | 42.1 (± 21.5) | 39.0 (± 28.0) | 40.3 (± 17.4) | 0.891 | 0.256 | 0.596 |
| VAS-GH, mm | 60.5 (± 16.9) | 42.4 (± 11.9) | 38.8 (± 16.5) | 0.056 | 59.7 (± 17.5) | 55.7 (± 24.5) | 57.0 (± 24.1) | 0.820 | 0.152 | 0.383 |
| SF-36 PCS | 33.9 (± 9.0) | 37.4 (± 7.6) | 39.1 (± 5.6)§ | 0.018 | 29.6 (± 6.2) | 38.0 (± 9.8) | 36.2 (± 10.6) | 0.039 | 0.559 | 0.258 |
| SF-36 MCS | 45.5 (± 10.9) | 46.6 (± 14.0) | 48.2 (± 14.5) | 0.532 | 50.9 (± 14.9) | 51.9 (± 10.7) | 52.5 (± 17.0) | 0.901 | 0.456 | 0.953 |
↵a Within subjects effect.
↵b Between subjects effect. P values for a and b are corrected upon the estimates of sphericity by Greenhouse and Geisser (1958) and Huynh and Feldt (1976). P values in boldface are statistically significant.
↵º p < 0.05 baseline vs Week 6 by pairwise comparison;
↵§ p < 0.05 baseline vs Week 12 by pairwise comparison.
↵§§ p < 0.01 baseline vs Week 12 by pairwise comparison.
↵* p < 0.05 Week 6 vs Week 12 by pairwise comparison. P values for pairwise comparison are Bonferroni corrected. HAQ: Health Assessment Questionnaire; DAS28: 28-joint Disease Activity Score; VAS: visual analog scale; GH: global health; SF-36: Medical Outcomes Study Short Form-36; PCS: physical component summary; MCS: mental component summary; ROM MP: ROM flexo-extension at metacarpophalangeal joints.