Objective: To compare a physical therapy program to usual care of systemic sclerosis (SSc) patients on disability.
Methods: 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.
Results: 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.
Conclusion: A personalized physical therapy program did not reduce disability at 12 months but had short-term benefits for patients with SSc.
Trial registration: ClinicalTrials.gov NCT00318188.
© 2016, American College of Rheumatology.