The effect of neuromodulation on pain management in women with fibromyalgia

Not Applicable

Recruiting

• Conditions: Pain, chronic pain, fibromyalgia; C23.888.592.612; C23.888.592.612.274; C05.651.324

• Registration Number: RBR-8wc8rjq
• Lead Sponsor: Centro Universitário da Grande Dourados

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-05
• Study Completion: 2021-06-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Confirmed diagnosis of fibromyalgia according to the criteria of the North American College of Rheumatology;
Clinical stability in relation to other associated systemic conditions, whether of a rheumatological, hematological, endocrine or metabolic nature;
Time availability to attend sessions;
Agreement to participate in the study by signing the Informed Consent Form, which will be read together with the patients and explained in detail;
Women;
Age in the age group between 18 to 60 years;
Score =18 on the Hamilton scale for anxiety;
Score = 7 on the Hamilton scale for depression.

Exclusion Criteria

Patients aged less than 18 years and older than 60 years;
Male patients;
Patients of indigenous ethnicity;
Psychiatric disorders, history of drug abuse or other behaviors that require psychiatric drug intervention;
Development of situations of clinical lack of control;
Even though there were no descriptions of serious complications such as seizures in subjects submitted to stimulation with ETCC, it was defined that the history of epilepsy, seizures or structural injuries of the central nervous system (CNS) would be a factor of non-participation in the study.
If the participant has been included in the survey, but shows some reaction, the CEP / CONEP system will be communicated and the participant will be referred for medical consultation. Depending on the opinion, the participant may be excluded from the survey.
All patients participating in the education group have a medical record in the physiotherapy sector of the Municipal Physiotherapy clinic in Fatima do Sul with medical and physiotherapeutic evaluation. Information regarding the inclusion and exclusion criteria will be collected from these records.
Participants who miss a session at any time during the survey will be excluded.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in pain in patients who received active ETCC greater than ETCC sham, determined by the visual analog scale and inventory of attitudes towards pain.

Secondary Outcome Measures

Name	Time	Method
Improvement in anxiety and depression symptoms in patients who received active ETCC greater than ETCC sham, determined using the Hamilton anxiety rating scale and the Hamilton depression rating scale;Improvement in quality of life and fatigue in patients who received active ETCC greater than ETCC sham, determined through the fatigue assessment scale and the WHO quality of life assessment instrument.