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Effects of a health education program for patients with fibromyalgia

The impact of a health education program on neuroimmune and behavioral aspects of fibromyalgia patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5tdnbr
Enrollment
Unknown
Registered
2014-05-29
Start date
2010-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, chronic intractable pain, unspecified pain

Interventions

Experimental group (27 women with fibromyalgia) and control group (31 women with fibromyalgia). The experimental group underwent a program of health education called Inter - Relational School of Fibro
Behavioural
I02.233.332

Sponsors

Universidade Federal de Minas Gerais - UFMG
Lead Sponsor
Centro Universitário de Formiga - MG (UNIFOR-MG)
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Female gender; aged between 18 and 60 years; fibromyalgia diagnosis confirmed by a medical specialist

Exclusion criteria

Exclusion criteria: Less than 18 years, over 60 years old; modification in the pharmacologic treatment in the last three months; chronic inflammatory condition associated; autoimmune disease associated; history or presence of psychiatric disorders, infectious diseases, use of anti-inflammatory, antiallergic or antibiotic drugs in the last three months, pregnant women, lactating, participation in lower 80% of the classes

Design outcomes

Primary

MeasureTime frame
Levels of cortisol in saliva (enzyme-linked immunosorbent assay) before and after intervention; inflammatory cytokine levels in serum (measured by flow cytometry)before and after intervention; 6-sulphatoxymelatonin levels in urine (measured by enzyme-linked immunosorbent assay before and after intervention), levels of anxiety (measured by the Inventory of anxiety trait and state )before and after intervention and impact of fibromyalgia on quality of life (measured by the Fibromyalgia impact questionnaire)before and after intervention.

Secondary

MeasureTime frame
Levels of salivary cortisol at 8am, 5pm and 10pm, measured by enzyme-linked immunosorbent assay, before and after the intervention. Plasma levels of anti-inflammatory cytokines IL-4 and IL-10, measured by flow cytometry, before and after the intervention. Plasma levels of pro-inflammatory cytokines IL-2, IL-6, TNF, IFN and IL-17, mesuradas by enzyme-linked immunosorbent assay, before and after the intervention levels. The ratio of the anti-inflammatory /proinflammatory cytokines, before and after the end of intervention. Urinary levels of 6-sulphatoxymelatonin collected between 20h and 08h, measured by enzyme immunoassay before and after the end of the study. Levels of trait and state of anxiety, assessed before and after the intervention. Impact of fibromyalgia on quality of life, assessed before and after the intervention. Correlation between the variables that were significant changed at the end of study.

Countries

Brazil

Contacts

Public ContactAndrei;Débora Pernambuco;Reis

Universidade Federal de Minas Gerais - UFMG;Universidade Federal de Minas Gerais - UFMG

pernambucoap@ymail.com;debsdavila@gmail.com+55 (37) 9905 9495;+55 (31) 3409-2520

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 23, 2026