François Rannou1, Isabelle Boutron2, Luc Mouthon3, Katherine Sanchez1, Vincent Tiffreau4, Eric Hachulla4, Philipe Thoumie5, Jean Cabane6, Emmanuel Chatelus7, Jean Sibilia7, Alexandra Roren1, Alice Berezne3, Gabriel Baron2, Raphael Porcher2, Loic Guillevin3, Philippe Ravaud2, Serge Poiraudeau1. 1. AP-HP Cochin Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France. 2. AP-HP Hôtel Dieu Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France. 3. Reference Center for Rare Diseases, AP-HP Cochin Hospital, and Université Paris Descartes Sorbonne Paris Cité, Paris, France. 4. Reference Center for Rare Diseases, Lille University Medical Center, University of Lille 2, Lille, France. 5. AP-HP Rothschild Hospital and Pierre and Marie Curie University, Paris, France. 6. AP-HP Saint-Antoine Hospital and Pierre and Marie Curie University, Paris, France. 7. Hôpital Hautepierre, Fédération de Médecine Translationnelle de Strasbourg, UMR INSERM 1109, Université de Strasbourg-Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
Abstract
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 theHealth 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.
RCT Entities:
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.
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