fibromyalgia
Conditions
Interventions
This is a two-arm, blinded, comparative, randomized controlled clinical trial
with an estimated total of 60 research participants divided into two groups: 30 research participants treated in the active group who will receive standard drug treatment, clinical follow-up and hypno
Sponsors
Clinica Ortopédica e Traumatologica S/A
Fundação Oswaldo Cruz - Instituto Gonçalo Muniz
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: volunteers with fibromyalgia; both sexes; age between 18 and 60 years; and moderate to severe chronic pain for at least 6 months; on stable analgesic treatment for chronic pain management for more than 1 month at the time of study enrollment
Exclusion criteria
Exclusion criteria: Patients who are not able to understand the informed consent;who have been treated with hypnosis before or are participating in another clinical trial; and with cognitive impairment of any kind; and with chronic pain caused by other medical condictions and previous surgical procedures that may affect the study's efficacy evaluations; with a a history or current of severe psychopathologies (severe depression, schizophrenia, psychosis, etc.) or undergoing treatment with psychotherapy; using opioids in schema not stable as defined by the protocol;and who have undergone any type of surgery whithin 6 months of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the change in pain intensity after treatment and in the long term by comparing pain intensity with baseline using the Numerical Pain Scale (END) tool | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life assessed by the WHOQOL-BRIEF questionnaire;Assessment of casttrophic thoughts and association of catastrophism with the Pain-Associated Catastrophism Scale (B-PCS);Assess the intensity of pain unpleasantness using the numerical scale (ENDD);Assess the quality and intensity of pain (sensory and affective) using the Short Form McGill Pain Questionnaire (SF-MGQ)?;Assess sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI-BR)?;Assess anxiety and depression assessed by the HADS tool score? | — |
Countries
Brazil
Contacts
Public ContactDaniela Dorta
Fundação Oswaldo Cruz - Instituto Gonçalo Muniz
Outcome results
None listed