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, p |
General data | ||||||||||
Age, yrs | 57.0 (± 10.0) | — | — | 57.4 (± 11.7) | — | — | ||||
Sex | 10 F | — | — | 10 F | — | — | ||||
Disease duration, yrs | 6.9 (± 4.1) | — | — | 6.7 (± 4.2) | — | — | ||||
Limited/ diffuse | 8 L:2 D | — | — | 8 L:2D | — | — | ||||
Dominant hand | 10 right | 10 right | ||||||||
Primary outcomes | ||||||||||
Dreiser’s Index | 13.9 (± 6.0) | 9.9 (± 6.8) | 7.7 (± 5.2)§ | 0.006 | 14.0 (± 6.4) | 12.0 (± 6.5) | 9.50 (± 5.2)§ | 0.006 | 0.496 | 0.984 |
HAQ | 1.49 (± 0.4)° | 0.76 (± 0.6) | 0.81 (± 0.6) | 0.016 | 1.56 (± 0.7)°° | 1.06 (± 0.6) | 1.09 (± 0.5) | 0.063 | 0.287 | 0.988 |
HAMIS R hand | 5.2 (± 6.2) | 3.8 (± 6.6) | 3.3 (± 6.0) | 0.016 | 4.7 (±3.0) | 3.2 (± 2.4) | 3.2 (± 2.4) | 0.104 | 0.832 | 0.246 |
HAMIS L hand | 4.7 (± 4.1) | 3.1 (± 4.3) | 2.2 (± 3.2) | 0.075 | 2.2 (± 2.0) | 1.6 (± 2.0) | 1.7 (± 2.1) | 0.529 | 0.401 | 0.124 |
Secondary outcomes | ||||||||||
Hand abduction R, cm | 6.6 (± 1.9) | 7.5 (± 1.6) | 7.3 (± 1.9) | 0.175 | 6.7 (± 1.8) | 7.3 (± 1.3) | 7.3 (± 1.0) | 0.321 | 0.948 | 0.848 |
Hand abduction L, cm | 7.8 (± 1.5) | 7.8 (± 1.9) | 8.0 (± 1.6) | 0.889 | 7.6 (± 2.1) | 8.0 (± 1.8) | 8.0 (± 1.6) | 0.390 | 0.985 | 0.723 |
Hand Grip R, mmHg | 55.8 (± 21.9) | 64.4 (± 25.7) | 71.7 (± 29.6) | 0.080 | 48.1 (± 30.9) | 60.0 (± 24.1) | 63.1 (± 35.8) | 0.078 | 0.598 | 0.884 |
Hand Grip L, mmHg | 60.8 (± 29.6) | 67.0 (± 31.2) | 76.1 (± 32.6)§ | 0.007 | 62.5 (± 30.7) | 70.0 (± 23.5) | 74.1 (± 30.5) | 0.376 | 0.947 | 0.830 |
Hand Pinch R, mmHg | 43.6 (± 25.3) | 54.4 (± 28.8) | 63.3 (± 28.0)§§ | 0.002 | 28.1 (± 15.8) | 40.6 (± 24.8) | 49.4 (± 5.7)§ | 0.002 | 0.236 | 0.963 |
Hand Pinch L, mmHg | 45.0 (± 27.5) | 52.2 (± 32.5) | 64.4 (± 26.3)§§ | 0.001 | 36.9 (± 17.5)°° | 51.3 (± 18.3) | 50.0 (± 22.7) | 0.226 | 0.487 | 0.312 |
ROM MP joint R, degrees | 77.4 (± 8.3)° | 88.4 (± 11.4) | 90.4 (± 12.0)§ | 0.011 | 80.6 (± 10.5) | 87.5 (± 5.3) | 91.1 (± 6.0)§ | 0.017 | 0.850 | 0.581 |
ROM MP joint L, degrees | 91.7 (± 8.7) | 97.1 (± 14.7) | 97.2 (± 7.5) | 0.118 | 83.1 (± 13.6)° | 93.1 (± 8.8) | 87.6 (± 21.2) | 0.393 | 0.124 | 0.658 |
Quality of life outcomes | ||||||||||
VAS pain, mm | 47.9 (± 26.5) | 38.6 (± 26.2) | 41.7 (± 34.3) | 0.676 | 42.4 (± 42.1) | 42.9 (± 36.4) | 65.4 (± 38.7) | 0.134 | 0.498 | 0.200 |
VAS-GH, mm | 55.0 (± 28.3) | 44.6 (± 17.8) | 45.9 (± 29.6) | 0.611 | 52.2 (± 35.4) | 45.9 (± 40.4) | 62.7 (± 34.7) | 0.256 | 0.648 | 0.290 |
SF-36 PCS | 32.4 (± 7.9) | 31.7 (± 9.8) | 33.1 (± 12.5) | 0.699 | 31.4 (± 13.9) | 34.7 (± 11.3) | 34.9 (± 8.7) | 0.251 | 0.821 | 0.389 |
SF-36 MCS | 43.2 (± 16.1) | 41.8 (± 13.1) | 44.4 (± 11.0) | 0.686 | 50.9 (± 13.8) | 53.8 (± 12.2) | 46.3 (± 16.0) | 0.264 | 0.279 | 0.218 |
↵a Within subject effect.
↵b Between subject effect. P values for a and b are corrected upon the estimates of sphericity by Greenhouse and Geisser (1958) and Huynh and Feldt (1976).
↵º p < 0.05 baseline vs Week 6 by pairwise comparison;
↵°° p < 0.01 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 values for pairwise comparison are Bonferroni corrected. P values in boldface are statistically significant. HAQ: Health Assessment Questionnaire; HAMIS: Hand Mobility in Scleroderma; 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.