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The effectiveness of Auricular Vagus Nerve Electrical Stimulation associated with Global Osteopathic Treatment in patients with Fibromyalgia

Effect of Transcutaneous Electrical Stimulation of the Vagus Nerve combined with Osteopathic Global Treatment in women with Fibromyalgia: clinical trial randomized controlled

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5xnhwsw
Enrollment
Unknown
Registered
2022-11-30
Start date
2023-04-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Interventions

This study is a single-blind randomized controlled clinical trial. Even so, it is characterized as parallel, since the participants will be submitted to only one of the proposed interventions. Randomi
E02.331.800

Sponsors

Universidade do Sul de Santa Catarina
Lead Sponsor
Universidade do Sul de Santa Catarina
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Female volunteers; residents of greater Florianópolis; clinical diagnosis of Fibromyalgia; over 18 years of age and must sign the Free and Informed Consent Form

Exclusion criteria

Exclusion criteria: Volunteers with cardiovascular diseases; pulmonary; kidneys; oncological; pacemaker; epilepsy; skin pathologies; infection; decompensated metabolic diseases; decompensated arterial hypertension; aquaphobia; joint prostheses that make the technique unfeasible with global osteopathic treatment; associated rheumatologic diseases; cognitive not preserved; musculoskeletal disorders that compromise the execution of the proposed interventions; immunosuppressed; pregnant or lactating women; skin irritation from electrical stimulation; piercing in the area of the concha cava and cymba of the ear where the electrostimulation will be performed; have urinary incontinence; fecal incontinence; decreased skin sensitivity and vestibular dysfunctions

Design outcomes

Primary

MeasureTime frame
Evaluate pain intensity using the visual analogue scale, which is an instrument that consists of the use of a horizontal line 10 centimeters in length numbered from 0 to 10, the participant must identify with a trace how much pain is at that moment and the presentation of the parameters will be numerical, being zero without any pain and the closer to the number 10, it means the maximum pain experienced, as well as graphic through the location on a body map of the regions with pain. Therefore, it will be observed whether or not there was a reduction in pain intensity before and after each intervention

Secondary

MeasureTime frame
Evaluate subjective sleep quality using the Pittsburgh Sleep Quality Index, which is a self-administered questionnaire consisting of 19 items, where the parameters for evaluation are numerical since the score of each component presents a scale with a variation of 0 to 3 points. Therefore, the maximum score is 21 points (the higher the score, the worse the sleep quality), for this reason the cut-off note to interpret will be if there is a score above 5 points, it will indicate poor sleep quality of the individual according to the literature. Finally, it will be observed whether or not there was a reduction in the index comparing the beginning with the end of the 12 visits (both control and treated groups);To evaluate the quality of life through the fibromyalgia impact questionnaire, which is an instrument that presents questions about functional, occupational and pain capacity that are distributed over ten questions. The parameter is numerical from 0 to 100 and is used to identify the impact of fibromyalgia on the patient's quality of life. The higher the score, the worse the impact. Finally, it will be observed whether or not there was a reduction in the score comparing the beginning with the end of the 12 consultations (both in the control and treated groups);Assessing quality of life using the Short Form Health Survey (SF-36) questionnaire, which consists of 36 items related to eight categories (mental health, emotional/social and physical aspects, functional capacity). The parameter is numerical and the lower the score, the worse the quality of life attributed to the individual. Finally, it will be observed whether or not there was a reduction in the score comparing the beginning with the end of the 12 consultations (both in the control and treated groups);Evaluate heart rate variability through the Nerve express method, which consists of evaluating the autonomic nervous system through a heart monitor, with a heart rate sensor that is adapted to transmit the info

Countries

Brazil

Contacts

Public ContactDaiana Salm

Universidade do Sul de Santa Catarina

daianasalm@hotmail.com+55(48)984907241

Outcome results

None listed

Source: REBEC (via WHO ICTRP)