Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases with progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily affect the skeletal muscles. Despite these advances, this group of diseases still continues to be associated with high morbidity and functional disability, mainly due to the proximal muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of these patients. On the other hand, the importance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
6
Patients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles
Samuel K Shinjo
São Paulo, Brazil
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration) electrical stimulation in patients with systemic autoimmune myopathies.
Time frame: 30 minutes after stimulation
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Time frame: 8 weeks after stimulation
Healthy Assessment Questionnaire (HAQ)
Specific questionnaires to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst)
Time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
Patient/Parent Global Activity
This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Physician Global Activity
This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. Pontuaction: 0 (best) - 10 (worst)
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Manual Muscle Testing
This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. Pontuaction 0 (worst) - 80 (best)
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)
This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. The questionnaire is a series of physician's assessments of disease activity. Score ranges: 0 (best) - 60 (worst).
Time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
Serum levels of muscle enzymes
This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase. International Unit: U/L.
Time frame: 4 times: (a) within 30 min before; (b) until 30 min after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Strength muscle tests
The dynamic 1-repetition maximum for the leg-press will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Strength muscle tests
The dynamic 1-repetition maximum for the bench-press exercises will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Strength muscle tests
Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
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