Pain Neuroscience Education as Treatment in Fibromyalgia Affected Patients

NCT ID: NCT03947502

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2018-08-31

Brief Summary

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).

Detailed 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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group with

Educational intervention in neurobiology of pain

Group Type: EXPERIMENTAL

Educational intervention in neurobiology of pain

Intervention Type: BEHAVIORAL

The educational intervention will intend to make the individual aware that in the processes of learning, sensitization, habituation and acquisition of beliefs about pain there are automatic unconscious mechanisms, which can be modulated through conscious behaviors. Based on this the investigators propose the active participation of patients in the process of desensitization of their central nervous system. The investigators will try to encourage attention and weaken the neuronal connections that make up the pain neuromatrix to establish new connections thanks to neuroplasticity.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational intervention in neurobiology of pain

The educational intervention will intend to make the individual aware that in the processes of learning, sensitization, habituation and acquisition of beliefs about pain there are automatic unconscious mechanisms, which can be modulated through conscious behaviors. Based on this the investigators propose the active participation of patients in the process of desensitization of their central nervous system. The investigators will try to encourage attention and weaken the neuronal connections that make up the pain neuromatrix to establish new connections thanks to neuroplasticity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osatzen Sociedad Vasca Medicina Familiar y Comunitaria

OTHER

Sponsor Role: lead

Responsible Party

maría muñoa capron-manieux

Head of Primary Care Setting (Alango)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PI2016097 (SO)

Identifier Type: -

Identifier Source: org_study_id