Fibromyalgia Musculoskeletal Pain
Conditions
Interventions
It is a controlled, randomized, double-blind clinical trial. Participants will be randomly allocated to the Functional Training group (22 participants) and the Resistance Training group (22 participan
Sponsors
Universidade Federal de Sergipe - UFS
Laboratório de Pesquisa em Neurociências
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: People with fibromyalgia of both sexes; aged between 18 and 60 years; diagnosis of fibromyalgia based on the recommendations of the American College of Rheumatology of 2016; respond negatively to all questions on the Physical Activity Readiness Questionnaire; physically independent; do not have disorders that prevent them from exercising; have not been engaged in physical exercise for at least three months
Exclusion criteria
Exclusion criteria: Neurological conditions that interfere with evaluations, such as paralysis, significant sensory alterations, and levels of consciousness/comprehension; advanced joint diseases; suspected thrombosis, heart diseases, and immediate post-operative periods; pregnancy; alcohol abuse and illicit substance use; active cancer; initiating another type of physical exercise during the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction of at least 30% in pain intensity relative to baseline is expected, as assessed by the 11-point Pain Numerical Rating Scale with data collected before and after the intervention; a reduction of at least 30% in pain intensity is considered clinically relevant, in accordance with the parameter used to calculate the study's sample size | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in temporal summation of pain is expected following the intervention, characterized by a diminished response to repetitive stimulation compared to baseline; this reduction is considered indicative of reduced pain facilitation, with data collected before and after the intervention;Modulation of electroencephalographic activity is expected following the intervention, assessed via electroencephalogram before and after the intervention, with the outcome defined as the change in brain activity parameters previously specified in the study protocol;Modulation of the immune response is expected, assessed by quantifying CD4+ and CD8+ T-lymphocyte subpopulations in peripheral blood, with data collected before and after the intervention; the outcome is defined as changes in the concentrations of these subpopulations following the different physical exercise protocols;A reduction in serum concentrations of pro-inflammatory markers—including tumor necrosis factor-alpha, interleukin-6, and interleukin-1 beta—is expected; these are to be assessed before and after the intervention, with the change in serum concentrations of these markers following the different physical exercise protocols serving as the outcome;A reduction in the impact of fibromyalgia is expected, as assessed by the Fibromyalgia Impact Questionnaire; a reduction of at least 14% in the total score relative to baseline is considered clinically relevant, with assessments performed before the intervention, after one month, after two months, and immediately after the intervention;An increase in the pressure pain threshold is expected, assessed via algometry before and after the intervention; an increase in the pressure pain threshold following the intervention is considered an improvement in pain sensitivity;A reduction in pain intensity and pain interference is expected, as assessed by the Brief Pain Inventory before and after the intervention; a reduction of at least 30% or 2 points in the score is consid | — |
Countries
BR
Contacts
Public ContactAndré Silva Santos
Universidade Federal de Sergipe - UFS
Outcome results
None listed