Chronic Pain Fibromyalgia
Conditions
Interventions
This is a randomized, controlled, evaluator-blinded clinical trial comprising 44 participants, who will be randomly allocated into two groups of 22 participants each. Randomization will be performed b
vital signs will be checked, including blood pressure (BP), heart rate (HR), and peripheral oxygen saturation (SpO2), to ensure safe conditions for performing the proposed procedures. Both groups will
Sponsors
Centro Universitário CESMAC (Centro de Estudos Superiores de Maceió)
Centro Universitário Cesmac
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with fibromyalgia by physicians; aged between 18 and 65 years.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they present cognitive impairments that compromise their ability to understand instructions or perform the proposed procedures; visual impairments that prevent the use of virtual reality; severe psychiatric or behavioral conditions that may interfere with participation or adherence to the protocol; a history of epilepsy; pregnancy; the presence of metallic cranial implants or implanted electronic devices incompatible with transcranial direct current stimulation (tDCS); as well as individuals who initiate any pharmacological, behavioral, or motor intervention protocol during the data collection period of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the reduction in average pain intensity in individuals with fibromyalgia. This outcome will be assessed using the Brief Pain Inventory (BPI). A reduction of 30% or greater in average pain intensity compared to baseline will be considered a clinically significant improvement.;To evaluate the reduction in the impact of fibromyalgia on participants’ functioning and quality of life. This outcome will be assessed using the Fibromyalgia Impact Questionnaire (FIQ). A reduction of 14% or greater in the total questionnaire score compared to baseline will be considered a clinically relevant improvement. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the reduction in fear of movement and reinjury in individuals with fibromyalgia. This outcome will be assessed using the Tampa Scale of Kinesiophobia (TSK). A reduction of 4 points or greater in the total scale score compared to baseline will be considered a clinically relevant change.;To evaluate improvements in participants’ functional mobility. This outcome will be assessed using the Timed Up and Go (TUG) test. A reduction of 1 second or greater in test completion time compared to baseline will be considered a clinically relevant improvement.;To evaluate the reduction in cognitive interference on motor performance during dual-task execution. This outcome will be assessed using the Cognitive Timed Up and Go (Cognitive TUG), through the calculation of Dual-Task Cost (DTC). A reduction of 10% or greater in the DTC percentage compared to baseline will be considered a clinically relevant improvement.;To evaluate improvements in participants’ sleep quality. This outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). A reduction of 3 points or greater in the total questionnaire score compared to baseline will be considered a clinically relevant improvement.;To evaluate the reduction in fatigue in individuals with fibromyalgia. This outcome will be assessed using the Multidimensional Fatigue Inventory (MFI-20), validated for Brazilian Portuguese. A reduction of 10% or greater in the total questionnaire score compared to baseline will be considered a clinically relevant improvement. | — |
Countries
BR
Contacts
Public ContactFelipe Rebêlo
Universidade Estadual de Ciências da Saúde de Alagoas
Outcome results
None listed