Dermatomyositis
Conditions
Interventions
Go Test and the 30-Second Chair Stand Test
quality of life assessment using the Health Assessment Questionnaire
disease activity assessment using the physician and patient Visual Analog Scale, Manual Muscle Testing 8, and the Myositis Disease Activity Assessment
fatigue assessment using the Modified Fatigue Impact Scale
and central sensitization assessment using the Central Sensitization Inventory. The main objective of the study is to investigate, in patients with IIM, the relationship between ultrasound parameters,
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age above 18 years at the time of diagnosis of Idiopathic Inflammatory Myopathies; patients with Dermatomyositis, Immune-mediated Necrotizing Myopathy, or Antisynthetase Syndrome; male and female; evidence of muscle activity at baseline; diagnosis confirmed within the last 18 months or a clinically and laboratory documented flare up, regardless of the time since diagnosis; ability to perform minimal voluntary contraction of the muscles being evaluated; agreement to participate in the study as per the Informed Consent Form
Exclusion criteria
Exclusion criteria: Other muscular diseases; associated neuropathies that significantly impair global function; severe orthopedic conditions that prevent the performance of basic functional tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: Changes in rectus femoris muscle ultrasound parameters are expected between baseline and the 6-month follow-up assessment. This outcome will be evaluated using musculoskeletal ultrasound, with measurements obtained at rest and during maximal voluntary isometric contraction. The following parameters will be assessed: a change in muscle thickness at rest of approximately 1 cm, a change in muscle thickness during maximal voluntary isometric contraction of approximately 1 cm, and relative echogenicity classified according to the Heckmatt scale, with a score lower than 2;Expected Outcome 2: Changes in objective functional capacity are expected after 6 months of follow-up. This outcome will be assessed using the Timed Up and Go (TUG) test and the 30-Second Chair Stand Test (30CST). The parameters evaluated will include a TUG completion time greater than 12 seconds and performance below the 25th percentile for sex and age group on the 30CST, based on the number of repetitions completed within 30 seconds | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: Persistent functional limitation is expected to be identified at the 6-month follow-up (T6), operationally defined as the presence of clinically relevant functional impairment. This outcome will be assessed using the Timed Up and Go (TUG), 30-Second Chair Stand Test (30CST), and Health Assessment Questionnaire (HAQ). The occurrence of at least one of the following criteria will be evaluated: a TUG completion time greater than 12 seconds, performance below the 25th percentile for sex and age group on the 30CST, and/or an HAQ score greater than or equal to 0.75, indicating clinically relevant functional impact;Expected Outcome 2: Serial changes in disease activity markers are expected throughout the follow-up period. This outcome will be assessed through standardized laboratory and clinical evaluations. Variations will be measured in serum levels of muscle enzymes, including creatine phosphokinase (CPK), aldolase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH), as well as changes in scores from the Manual Muscle Testing-8 (MMT-8), the Myositis Disease Activity Assessment Visual Analog Scale (MYOACT-VAS), the Patient Visual Analog Scale (Patient VAS), and the Physician Visual Analog Scale (Physician VAS);Expected Outcome 3: Symptoms and central mechanisms associated with functional disability are expected to be identified at the 6-month follow-up. This outcome will be assessed through the evaluation of pain intensity, fatigue, and central sensitization using validated instruments. The parameters evaluated will include scores on the Pain Visual Analog Scale (VAS) and body pain diagram to characterize pain distribution, the Modified Fatigue Impact Scale (MFIS) to assess fatigue, and the Central Sensitization Inventory (CSI) to identify signs and symptoms consistent with central sensitization | — |
Countries
BR
Contacts
Public ContactMayara Rodrigues
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed