To compare a physical therapy program to usual care of systemic sclerosis (SSc) patients on disability.
A 12-month followup, parallel-group randomized controlled trial involving a modified Zelen design was conducted in 4 tertiary-care hospitals. Patients were enrolled if they had a disability rating ≥0.5 on the Health Assessment Questionnaire disability index (HAQ DI) or symptoms of decreased mouth opening or limited range of motion of at least 1 joint. The experimental intervention (n = 112, of which 110 were analyzed) was a 1-month personalized supervised physical therapy program provided by trained care providers followed by home sessions. The comparator (n = 108, and all 108 were analyzed) was usual care that could include ambulatory physical therapy. The primary outcome was the HAQ DI score.
There was no statistically significant difference in disability at 12 months (HAQ DI score between-group difference -0.01 [95% confidence interval (95% CI) -0.15, 0.13]; P = 0.86). Disability was reduced at 1 month for patients in the physical therapy group (HAQ DI between-group difference -0.14 [95% CI -0.24, -0.03]; P = 0.01); at 6 months the HAQ DI score between-group difference was -0.12 (95% CI -0.23, 0.01); P = 0.054. There was a statistically significant difference for hand mobility and function, and for pain, at 1 month. Microstomia was lower in the physical therapy group at 1, 6, and 12 months (between-group difference at 12 months 1.62 [95% CI 0.32, 2.93]; P = 0.01). No differences in adverse effects were observed.
A personalized physical therapy program did not reduce disability at 12 months but had short-term benefits for patients with SSc.