Fibromyalgia
Conditions
Interventions
This is a two-arm, double-blind, randomized clinical trial. The sample will consist of 28 patients with a clinical diagnosis of fibromyalgia. Participants who meet the eligibility criteria will be ran
Sponsors
Universidade Federal de Santa Maria
Universidade Federal de Santa Maria
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Volunteers diagnosed with fibromyalgia, characterized by pain upon palpation in at least 11 of the 18 specific tender points for more than three months, on one or both sides of the body, above and below the waist;
Exclusion criteria
Exclusion criteria: Having pituitary tumors or adrenal hyperplasia; epilepsy; diabetes mellitus; cardiovascular diseases; renal failure; drug or alcohol dependence; being pregnant or breastfeeding; use of a pacemaker; having undergone acupuncture sessions to treat insomnia within the past 30 days; untreated laryngeal or thyroid disease; history of respiratory, head, or neck surgery; presence of hearing complaints; self-reported smoking or alcohol consumption; being a voice professional; neurological disease; or pulmonary disease confirmed by spirometry demonstrating an obstructive ventilatory disorder; communication impairments or cognitive deficits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction of 6.07 ± 2.82 in the Voice Handicap Index is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group. This is the study’s primary outcome;An improvement in sleep quality, as measured by the Pittsburgh Sleep Quality Index, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;A reduction in insomnia severity, as measured by the Insomnia Severity Index, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;A reduction in vocal symptoms, as measured by the Voice Symptom Scale, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;A reduction in vocal fatigue, as measured by the Vocal Fatigue Index, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;A reduction in fatigue severity, as measured by the Fatigue Severity Scale, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;A reduction in fatigue intensity, as measured by the Chalder Fatigue Scale, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement in pulmonary function, as measured by spirometry, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;An improvement in respiratory muscle strength, as measured by manovacuometry, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;An improvement in handgrip strength, as measured by dynamometry, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;A reduction in pain, as measured by algometry, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;A reduction in anxiety and depression, as measured by the Anxiety and Depression Scale, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group;An improvement in autonomic control, as measured by time and frequency domain parameters of Heart Rate Variability, is expected in the Electroacupuncture group compared to the Sham Electroacupuncture group | — |
Countries
Brazil
Contacts
Public ContactCarine Callegaro
Universidade Federal de Santa Maria
Outcome results
None listed