Fibromyalgia
Conditions
Interventions
This is a randomized, controlled, blinded clinical trial. Sixty participants will be randomized (30 to the experimental group and 30 to the placebo group). Randomization will be performed using balanc
Sponsors
Sociedade de Educação Superior e Cultura Brasil S.A.
Sociedade de Educação Superior e Cultura Brasil S.A.
Eligibility
Sex/Gender
Female
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: Women aged 30 to 70 years; belonging to AGFESC; residing in municipalities within the AMREC, AMESC, and AMUREL regions; who have a prior medical diagnosis of fibromyalgia; chronic pain with a score equal to or greater than four on the Visual Analogue Scale (VAS); are available to participate in all stages of the study, including intervention sessions and assessments; and express their agreement to participate by signing the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Women who present with active skin lesions at the laser application sites, such as open wounds or ulcerations; clinical conditions that contraindicate the use of phototherapy, such as active malignant neoplasms; inflammatory dermatological diseases at the application sites, such as psoriasis or dermatitis; decompensated or inadequately treated psychiatric disorders; pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A clinically significant reduction (= 2 points) in pain intensity, as measured by the Visual Analogue Scale, is expected in participants with fibromyalgia. Assessment will be conducted at week 1 (before receiving treatments) and week 5 (after laser sessions at acupuncture points) | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the total pain index assessed by the McGill Pain Questionnaire will be reduced, considering the sum of scores in the sensory, affective, evaluative, and miscellaneous categories of participants with Fibromyalgia. The assessment will be carried out in week 1 (before receiving treatments) and in week 5 (after laser sessions on acupuncture points);A change in the degree of central sensitization, assessed by the Central Sensitization Inventory, Brazilian version (CSI-BP), is expected, with higher values ??indicating a greater degree of sensitization in participants with Fibromyalgia. The assessment will be carried out in week 1 (before receiving treatments) and in week 5 (after laser sessions on acupuncture points);The study aims to observe the level of pain catastrophizing, assessed by the Pain Catastrophizing Scale (PCS), with higher scores reflecting greater difficulty in coping with pain among participants with fibromyalgia. The assessment will be conducted in week 1 (before receiving treatments) and week 5 (after laser sessions on acupuncture points);The study aims to observe the sleep quality of participants with Fibromyalgia, assessed using the Brazilian version of the Pittsburgh Sleep Quality Index (PSQI-BR), considering scores greater than five as indicative of poor sleep quality. The assessment will be carried out in week 1 (before receiving treatments) and in week 5 (after laser sessions on acupuncture points);The study aims to observe the functional impact and quality of life of participants with Fibromyalgia, measured by the Fibromyalgia Impact Questionnaire Revised, Brazilian version (FIQR-Br), which assesses functional capacity, symptoms, and repercussions of fibromyalgia in daily life. The assessment will be carried out in week 1 (before receiving treatments) and in week 5 (after laser sessions on acupuncture points);It is expected to find the activity of the autonomic nervous system by analyzing heart rate variability at the beginnin | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Universidade do Sul de Santa Catarina
Outcome results
None listed