Clinical trial NCT03947502: Pain Neuroscience Education as Treatment in Fibromyalgia Affected Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
pain
neurobiology
education
movement
Lead sponsor: Osatzen Sociedad Vasca Medicina Familiar y Comunitaria
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre (5 nodes) randomized clinical trial, Pain neuro education based on 6 weekly classes of 2 hours for patients affected by fibromyalgia, taught by a multidisciplinary group. Controlled with usual therapies treated group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To asses the number of patients that stop fulfilling fibromyalgia criteria (American College of Reumathology 2010 criteria).
timeFrame: It will be measured at 12-months after the beginning of the intervention,
Secondary outcomes:
measure: To asses the effectiveness by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.
timeFrame: It will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,
measure: To asses the decrease in pain by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.
timeFrame: t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,
measure: To assesthe decrease in catastrophising by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.
timeFrame: t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,
measure: To asses the decrease in anxiety and depression by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.
timeFrame: t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,
measure: To asses the security of modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.
timeFrame: It will be measured at 12-months after the beginning of the intervention,
Other outcomes:
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