Pain Neuroscience Education as Treatment in Fibromyalgia Affected Patients

Osatzen Sociedad Vasca Medicina Familiar y Comunitaria

Status: Completed

Conditions: Fibromyalgia

Treatments: Behavioral: Educational intervention in neurobiology of pain

Study type: Interventional

Funder types: Other

Identifiers

NCT03947502

PI2016097 (SO)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of fibromyalgia stablished by the American Rheumatology College criteria 2010,
• Older than 18 years
• Have signed the informed consent

Exclusion criteria

• Psychiatric or neurological disorder which could prevent assimilate the training
• Refusal to participate in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Intervention Group with

Experimental group

Description:

Educational intervention in neurobiology of pain

Treatment:

Behavioral: Educational intervention in neurobiology of pain

Control group

No Intervention group

Description:

The control group is treated with usual medication for fibromyalgia, anxiolytics, antidepressants, analgesics, ... Depending on the medical needs and criteria of patients´s primary care physician.