Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies

NCT03751644 | Completed DMC

• 1 other identifier: MYO-HCFMUSP-07
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Electrical Remodeling; Rheumatic Diseases; Myopathy

Keywords

systemic autoimmune myopathies; Peripherical neuromuscular electrical stimulation; myositis

Outcome Measures

Primary Outcomes (2)

• 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.

  30 minutes after stimulation

• Frequency of treatment-emergent adverse events [safety and tolerability]

  Frequency of disease relapsing (based on the questionnaire of secondary outcome

  8 weeks after stimulation

Secondary Outcomes (9)

• Healthy Assessment Questionnaire (HAQ)

  3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation

• Patient/Parent Global Activity

  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

  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

  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)

  3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation

Study Arms (2)

Electrical stimulation

EXPERIMENTAL

After local antisepsis, 4 electrodes will be placed at the proximal and distal extremities of the lateral and vastus medialis muscles of dominant limb. A positive, single-phase pulsating (intermittent) current with a rectangular waveform will be delivered with a duty cycle of 10 to 15 seconds shutdown at a frequency of 60 Hertz with a pulse width of 400 microseconds for 30 minutes. To control the degree of muscle activation, electrical stimulation will be administered at an intensity that will consistently produce a target torque equal to 15% of maximal voluntary contraction, as monitored in real time through torque output. The desired intensity of stimulation and intensity adjustments throughout the treatment will be evaluated in all patients.

Other: Electrical stimulation

Placebo

NO INTERVENTION

Patients will not submitted to electrical stimulation.

Interventions

Electrical stimulation OTHER

Patients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles

Electrical stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Samuel K Shinjo

São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Atrial Remodeling; Rheumatic Diseases; Muscular Diseases; Myositis

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Samuel K Shinjo

  Universidade de Sao Paulo - Rheumatology Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients will be randomized by non-investigator from the present study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: Patients with systemic autoimmune myopathies will receive or not the periphericalneuromuscular electrical stimulation in thigh muscles

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 23, 2018
• Study Start: November 1, 2018
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

BR (1)