Clinical trial NCT03751644: Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies
Official title: Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electrical Remodeling
Rheumatic Diseases
Myopathy
Keywords: systemic autoimmune myopathies
Peripherical neuromuscular electrical stimulation
myositis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with systemic autoimmune myopathies will receive or not the periphericalneuromuscular electrical stimulation in thigh muscles
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Classification criteria - EULAR/ACR 2017
* Classification criteria - Connors et al.
* Objective muscle limb weakness

Exclusion Criteria:

* Neoplasia
* Using heart pacemarker
* Using visceral metalic clips
* Infections (HIV, HTLV-1, Hepatitis, etc)
* Pregnancy
* Previous historical of convulsions or epilepsies

Primary outcomes:
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: 30 minutes after stimulation
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: 8 weeks after stimulation
Secondary outcomes:
measure: Healthy Assessment Questionnaire (HAQ)
timeFrame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
measure: Patient/Parent Global Activity
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
measure: Physician Global Activity
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
measure: Manual Muscle Testing
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
measure: Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)
timeFrame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
measure: Serum levels of muscle enzymes
timeFrame: 4 times: (a) within 30 min before; (b) until 30 min after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
measure: Strength muscle tests
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
measure: Strength muscle tests
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
measure: Strength muscle tests
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Samuel K Shinjo
Study officials:
affiliation: Universidade de Sao Paulo - Rheumatology Division
name: Samuel K Shinjo
role: PRINCIPAL_INVESTIGATOR
References: