Effect of rehabilitation in systemic sclerosis
Prof Francois RANNOUa
a CHU Cochin, APHP
Importance Physical therapy could be of interest to reduce disability of systemic sclerosis (SSc) patients.
Objective To develop a physical therapy program for SSc and compare its efficacy with that of usual care.
Design 12-month, parallel-group randomized controlled trial involving a modified Zelen design conducted between September 2005 and October 2011. Randomization was computer-generated with allocation concealment by fax to a central coordinating office. Investigators were not blinded, but participants in the control group were blinded to study hypothesis.
Setting 4 tertiary-care hospitals.
Participants Patients were enrolled if they had a SSc diagnosis, a disability rating ≥ 0.5 on the Health Assessment Questionnaire Disability Index (HAQ-DI) or complaints of decreased mouth opening or limited range of motion of at least one joint.
Interventions The experimental intervention was a 1-month personalized supervised physical therapy program provided by specifically trained care providers followed by home sessions. The comparator was usual care.
Main Outcomes and Measures The primary outcome was the HAQ-DI score at 12 months.
Results In the intention-to-treat analysis, as compared with the usual care group (n=108), patients in the physical therapy group (n=110) showed reduced disability at 1 month (HAQ-DI between-group difference ?0.14; 95% confidence interval [CI] -0.24 to -0.03; p=.01), at 6 months the HAQDI scores between-group difference was -0.12; 95% CI, -0.23 to 0.01; p = 0.054. There was no statistically significant difference at 12 months (between-group difference at 12 months, -0.01; 95% CI -0.15 to 0.13; p=0.86). There was a statistically significant difference for hand mobility and function, and pain, at 1 month but no difference at 12 months. 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 to 2.93; p=0.01). No differences in adverse effects were observed between the two treatment groups.
Conclusions and Relevance
A 1-month personalized supervised physical therapy program followed by home exercise sessions had short-term benefits for patients with SSc but did not reduce disability at 12 months. The program had long-term benefits for microstomia.
Trial registration clinicaltrials.gov identifier: NCT00318188**
Keywords : systemic sclerosis, rehabilitation