Fibromyalgia Clinical Trial
Official title:
Effectiveness of a Structured Group Intervention Based on Pain Neuroscience Education for Patients With Fibromyalgia in Primary Care: a Multicenter Randomized Open-label Controlled Trial
Fibromyalgia (FM) is a chronic, complex and disabling clinical entity that has an average
global prevalence of 2.7%. It occurs mainly in women in a 3: 1 ratio. It is characterized by
persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous
systemic symptoms such as dizziness, migraine, digestive alterations or sensory intolerances.
At present there is no pharmacological treatment with specific indication for fibromyalgia.
Usually, non-curative treatments are recommended that alleviate the symptoms of the patients
and improve their quality of life and functionality.
The investigator's main goal is to evaluate the effectiveness at 1 year of a group
educational intervention in neurobiology of pain in patients affected by fibromyalgia, in
comparison with the evolution of a control group that will continue only with its usual
treatments. This intervention will be carried out in the field of Primary Care and its
effectiveness will be assessed by reducing or not having diagnostic criteria (reduction of
areas of pain and of the severity of fibromyalgia symptoms), using the Criteria for the
Diagnosis of Fibromyalgia of the American College of Rheumatology 2010 (ACR 2010).
Methodology of the project In group sessions of 14 patients, a health professional explained
the neurological mechanisms that are behind the perception of pain, fatigue and illness from
the recent knowledge in neuroscience about brain and pain, as well as the brain's ability to
change patien´s behaviour thanks to neuroplasticity.
There will be 5 sessions of 2 hours per week and another one per month. Before the latter, a
workshop of 2 hours of movement will be given.
Each week the contents of the class and other complementary materials will be sent to the
patients.
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