Systemic Sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of systemic sclerosis by rheumatologist; 18 years of age or over; presence of impairment of the functionality of the hand determined by score in Cochin scale greater or equal 10.
Exclusion criteria
Exclusion criteria: Superposition with other autoimmune or inflammatory rheumatologic diseases; presence of scleroderma-like diseases (eosinophilic fasciitis, nephrogenic systemic fibrosis, scleromyxedema); presence of acute arthritis or myositis in activity; presence of ulcers in active hands; presence of amputation in upper limbs; physical therapy in the last three months; difficulty in moving or unable to attend the scheduled treatment sessions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome 1: Functionality of hands - Measured by Cochin Hand Functional Scale (COCHIN) at the first evaluation, after 6 weeks and after 12 weeks in both groups. A variation of 11.8 points is required to be clinically significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 3 Range of Hand Movement: Measured by Delta finger-to-palm (DFTP) and Modified Hand Mobility in Scleroderma (HAMIS). DFTP: measured with a ruler (cm) the flexion movement of the fingers, check if there was decrease in cm after 6 and 12 weeks. HAMIS: Each item is rated on a scale of 0 (no difficulty) to 3 (can not do), with a total score of up to 12 points for each hand.;Secondary outcome 4 Muscle strength: As measured by the dynamometer, the force is recorded in kilograms (kg), it is expected to increase the force through the KG after 12 weeks of intervention.;Secondary Outcome 5 Pain: Measured by Visual Analogue Scale (EVA). Used a ruler from 0 to 10 cm, 0 (without pain) and 10 (greater pain experience).;Secondary Outcome 6 Adverse events: Measured through a questionnaire prepared by the researchers. Qualitative measure.;Secondary Outcome 7 Perception of change: Measured by the evaluation of the scale of global perception of change (PGIC Portuguese version). Being classified with the numberings of 1 (without changes) to 7 (much better).;Secondary Outcome 1 Disability: Measured by the Scleroderma Health Assessment Questionnaire (SHAQ) ranging from 0 to 3 - without any difficulty (0), with some difficulty (1), with great difficulty (2) and unable to do (3). The score range from 0 to 3 represents the minimum limitation for 0 and maximum for 3.;Secondary Outcome 2 Quality of life: Measured by the Medical Outcome Study Short Form 12-Item (SF-12). Being 0 the worst result and 100 the best result related to health. | — |
Countries
Brazil
Contacts
Universidade Federal de Pernambuco ;Universidade Federal de Pernambuco