Table 1.

Results of patients with systemic sclerosis (SSc) enrolled in the 2 arms of the Re.Mo.Te. clinical trial. Data are mean (± SD) unless otherwise indicated.

Experimental ArmControl Arm
VariablesBaseline (T0)Week 6 (T1)Week 12 (T2)Change Over Time, paBaseline (T0)Week 6 (T1)Week 12 (T2)Change Over Time, paCases vs Controls, pbInteraction Effect, p
General data
  Age, yrs57.0 (± 10.0)57.4 (± 11.7)
  Sex10 F10 F
  Disease duration, yrs6.9 (± 4.1)6.7 (± 4.2)
  Limited/ diffuse8 L:2 D8 L:2D
  Dominant hand10 right10 right
Primary outcomes
  Dreiser’s Index13.9 (± 6.0)9.9 (± 6.8)7.7 (± 5.2)§0.00614.0 (± 6.4)12.0 (± 6.5)9.50 (± 5.2)§0.0060.4960.984
  HAQ1.49 (± 0.4)°0.76 (± 0.6)0.81 (± 0.6)0.0161.56 (± 0.7)°°1.06 (± 0.6)1.09 (± 0.5)0.0630.2870.988
  HAMIS R hand5.2 (± 6.2)3.8 (± 6.6)3.3 (± 6.0)0.0164.7 (±3.0)3.2 (± 2.4)3.2 (± 2.4)0.1040.8320.246
  HAMIS L hand4.7 (± 4.1)3.1 (± 4.3)2.2 (± 3.2)0.0752.2 (± 2.0)1.6 (± 2.0)1.7 (± 2.1)0.5290.4010.124
Secondary outcomes
  Hand abduction R, cm6.6 (± 1.9)7.5 (± 1.6)7.3 (± 1.9)0.1756.7 (± 1.8)7.3 (± 1.3)7.3 (± 1.0)0.3210.9480.848
  Hand abduction L, cm7.8 (± 1.5)7.8 (± 1.9)8.0 (± 1.6)0.8897.6 (± 2.1)8.0 (± 1.8)8.0 (± 1.6)0.3900.9850.723
  Hand Grip R, mmHg55.8 (± 21.9)64.4 (± 25.7)71.7 (± 29.6)0.08048.1 (± 30.9)60.0 (± 24.1)63.1 (± 35.8)0.0780.5980.884
  Hand Grip L, mmHg60.8 (± 29.6)67.0 (± 31.2)76.1 (± 32.6)§0.00762.5 (± 30.7)70.0 (± 23.5)74.1 (± 30.5)0.3760.9470.830
  Hand Pinch R, mmHg43.6 (± 25.3)54.4 (± 28.8)63.3 (± 28.0)§§0.00228.1 (± 15.8)40.6 (± 24.8)49.4 (± 5.7)§0.0020.2360.963
  Hand Pinch L, mmHg45.0 (± 27.5)52.2 (± 32.5)64.4 (± 26.3)§§0.00136.9 (± 17.5)°°51.3 (± 18.3)50.0 (± 22.7)0.2260.4870.312
  ROM MP joint R, degrees77.4 (± 8.3)°88.4 (± 11.4)90.4 (± 12.0)§0.01180.6 (± 10.5)87.5 (± 5.3)91.1 (± 6.0)§0.0170.8500.581
  ROM MP joint L, degrees91.7 (± 8.7)97.1 (± 14.7)97.2 (± 7.5)0.11883.1 (± 13.6)°93.1 (± 8.8)87.6 (± 21.2)0.3930.1240.658
Quality of life outcomes
  VAS pain, mm47.9 (± 26.5)38.6 (± 26.2)41.7 (± 34.3)0.67642.4 (± 42.1)42.9 (± 36.4)65.4 (± 38.7)0.1340.4980.200
  VAS-GH, mm55.0 (± 28.3)44.6 (± 17.8)45.9 (± 29.6)0.61152.2 (± 35.4)45.9 (± 40.4)62.7 (± 34.7)0.2560.6480.290
  SF-36 PCS32.4 (± 7.9)31.7 (± 9.8)33.1 (± 12.5)0.69931.4 (± 13.9)34.7 (± 11.3)34.9 (± 8.7)0.2510.8210.389
  SF-36 MCS43.2 (± 16.1)41.8 (± 13.1)44.4 (± 11.0)0.68650.9 (± 13.8)53.8 (± 12.2)46.3 (± 16.0)0.2640.2790.218
  • 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.