Effect of Vagus Nerve Stimulation on Fibromyalgia

Not Applicable

Recruiting

• Conditions: Depressive episodes; generalized anxiety disorder; non-organic sleep disorders due to emotional factors; CID 10 M79.7

• Registration Number: RBR-10d3crcf
• Lead Sponsor: niversidade Federal de Santa Catarina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-05
• Last Update Posted: 29 May 2023
• Study Completion: 2023-08-28

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Female individuals who meet the following criteria will be included in the sample: age between 18 and 65 years; diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (ACR); pain equal to or greater than 3 points (END);
being able to walk independently, with or without assistance; understand the Brazilian Portuguese language well enough to complete the questionnaires.

10 healthy female subjects, aged between 18 and 65 years, will also be included, who can understand the Brazilian Portuguese language well enough to complete the questionnaires.

Exclusion Criteria

Individuals who meet the following criteria will be excluded from the study: presence of red flags such as fracture, malignancy / cancer, or pathologies that justify the presence of pain and inflammation; suspected or confirmed pregnancy; cognitive changes; unstable heart conditions; auricular lesions or absence of it.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate pain improvement using the Numerical Pain Scale (END), expecting a numerical reduction in the scale, where the higher the number (0-10), the greater the perception of pain; this condition will be assessed before treatment, daily, at the end of treatment and 3 months after the last visit.<br>