Fibromyalgia Chronic pain
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. With the assistance of an external collaborator and without the researcher&apos
s knowledge, the 60 study participants will be randomly allocated into two groups (intervention and control), with 30 participants in each group. Following the randomization of participants, each part
therefore, the evaluator and the participant are blinded during randomization and intervention. During the bottle randomization process, sequential numbers from 001 to 060 will be written in the same
Sponsors
Coordenação de Cursos de Pós-Graduação Lato Sensu e Extensão - Fundação de Ensino e Pesquisa em Ciências da Saúde
Coordenação de Cursos de Pós-Graduação Lato Sensu e Extensão - Fundação de Ensino e Pesquisa em Ciências da Saúde
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants with a prior diagnosis of Fibromyalgia by a rheumatology team, according to the 2016 American College of Rheumatology guidelines. Patients presenting with moderate or severe symptoms despite current therapy. Patients who have had at least one medical consultation in the last year at their health center. Patients aged between 18 and 70 years. Both sexes. Patients aged 60-70 years with a Barthel Index of 100 points, preserved renal and cardiac function, and no history of dementia
Exclusion criteria
Exclusion criteria: Patients under 18 years of age and over 70 years of age. Patients with decompensated organic comorbidities and/or high-risk psychiatric conditions (schizophrenia, psychosis, severe personality disorder, current suicidal ideation). Patients with another well-defined condition causing chronic pain. Current pregnancy, lactation. Moderate to severe cognitive dysfunction. Report of sensitivity to cannabinoids, addressed individually during the first medical evaluation, respecting the participant's desire for confidentiality regarding any previous problems, establishing a relationship of trust between doctor and participant, leaving the decision to participate in the research open or not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim is to find a new therapeutic approach for a syndrome with a limited range of treatments. It is anticipated that muscle pain will be reduced by more than 30%, and that sleep quality and quality of life will improve in pre- and post-intervention measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary stages are expected. | — |
Countries
BR
Contacts
Public ContactFelipe Bezerra
Fundação de Ensino e Pesquisa em Ciências da Saúde
Outcome results
None listed