Fibromyalgia Chronic Pain
Conditions
Interventions
This study is a randomized, longitudinal, parallel-group, single-blind clinical trial in which participants were blinded to group allocation, while the researchers responsible for administering the in
3 times per week, on alternate days)
(2) Sham PE (n = 15
placebo physical exercise, 3 times per week, on alternate days)
(3) tDCS (n = 15
20 minutes, anode at C3, right supraorbital cathode, 5 times per week)
(4) EF + tDCS (n = 15)
and (5) Sham PE + tDCS (n = 15). The intervention began with an in-person session at the Laboratory of Electrical Stimulation of the Nervous System (LabEEL), during which participants received trainin
Sponsors
Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro
Universidade do Estado do Rio de Janeiro
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants aged eighteen years or older; both sexes; presenting active pain symptoms within the last 30 days; physically inactive for at least two months; cognitively able to understand and provide clinical outcome data.
Exclusion criteria
Exclusion criteria: Significant cognitive and/or motor impairment; History of licit or illicit drug abuse within the last six months; Pregnancy or plans to become pregnant during the study period; Restrictions preventing the performance of the proposed physical exercises; Cranial metallic implants, cranial deformities, or skin lesions at the stimulation site; Lack of internet access.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: The study is expected to determine the clinical effects of home-based transcranial direct current stimulation associated with physical exercise. ;Observed Outcome 1: A main effect of time was observed, with reductions in pain (NRS, p is less than 0.001) and functional impact (FIQR-BR, p is less than 0.001), without interaction between time and group. The MCID was achieved for pain (is greater than or equal to1.5 points) and functional impact (is greater than or equal to14%) in groups receiving tDCS, both alone and in combination. In exploratory analyses, pain did not differ between responders (RESP) and non-responders (NRESP); however, within the tDCS group, responders showed a longer time since diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: It is expected to verify the effects of the proposed therapies individually, as well as in combination, on the basic symptoms of patients with chronic pain; analyze the neurophysiological effects and study the corticospinal plasticity promoted by the remote intervention with transcranial direct current stimulation (tDCS) associated with physical exercise, through central electrophysiological markers using TMS; determine whether the activation of corticospinal neuronal populations induced by the performance of low-intensity movements is sufficient to produce clinical and neuroplastic effects associated with tDCS in patients with chronic pain, or whether physical exercise must reach sufficient intensity to induce physical conditioning; and develop methodologies for remote monitoring of the evolution of the proposed intervention.;Observed Outcome 1: Results were observed across the four secondary domains. In the clinical domain (fatigue/sleep), MDF-FIBRO-17 (F(2.81, 95.50) equal to 16.73, p less than 0.001, ?p² equal to 0.33) and MSQ-BR (F(2.17, 73.73) equal to 11.42, p less than 0.001, ?p² equal to 0.25) demonstrated a main effect of time. In the psychological domain, BP-PCS (F(2.65, 89.99) equal to 7.34, p less than 0.001, ?p² equal to 0.18) and MADRS-S (F(2.34, 77.22) equal to 3.83, p equal to 0.010, ?p² equal to 0.10) also showed a main effect of time; however, only MADRS-S demonstrated a significant interaction between group and time (F(4.68, 77.22) equal to 4.10, p equal to 0.001, ?p² equal to 0.20). Regarding quality of life, the WHOQOL-BREF (F(2.29, 77.73) equal to 8.10, p less than 0.001, ?p² equal to 0.19) demonstrated a main effect of time. In the physical performance domain, the 30-second chair stand test (30s-CST) (F(2.31, 78.42) equal to 23.39, p less than 0.001, ?p² equal to 0.40) also showed a main effect of time. For the Tampa Scale of Kinesiophobia (TSK), no main effects of time or group were identified, and no interaction between | — |
Countries
BR
Contacts
Public ContactMarcos Russo
Universidade do Estado do Rio de Janeiro
Outcome results
None listed