Effectiveness Pain Neuroscience Education In The Executive Functions In Patients With Fibromyalgia (PNE)

Instituto Neurociencia Del Dolor

Status: Enrolling

Conditions: Fibromyalgia; Neuroscience; Executive Function

Treatments: Other: Pain Neuroscience Education; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05084300

INeurocienciaDolor0001

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 FM. Usually, non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality.

Many studies have shown cognitive impairment in FM patients compared to control groups, and FM patients mainly show problems with working memory processes and / or in their attentional and executive domains, as well as in speed of speech. processing (BD Dick, Verrier, Harker, & Rashiq, 2008; Glass, 2009; Tesio et al., 2015; Williams, Clauw, & Glass, 2011).

Many patients with FM have little understanding of their condition, leading to maladaptive pain cognitions and coping strategies. Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia. This study aimed to explore the effectiveness of pain neuroscience education in patients with FM.

Therefore, this research aims to analyze the effectiveness of the neuroscience education program on pain in executive functions and the intensity of pain in patients with FM.

Full description

The design of the present study will be a parallel-group randomized controlled trial that will be performed between september 2021 and march 2022.

Total = 62 patients. Experimental: PNE (31), Control: Usal care (31). Experimental: In individualized sessions to 31 patients, a health professional will explain 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 10 sessions of 35 minutes, 2 times per week.

Each week the contents of the class and other complementary materials will be sent to the patients.

He outcomes will be assessed at baseline (t1) and one week after intervention (t2). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.

Enrollment: 62 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) Be female
• (2) Age between 40-60 years.
• (3) Sign the consent form.
• (4) Diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
• (5) Mini Mental State Examination Score greater than or equal to 26 points
• (6) Schooling of at least 12 years (basic primary and secondary).
• (7) Have Spanish as their native language
• (8) Internet access

Exclusion criteria

• (1) Pregnant woman
• (2) Illiterate
• (3) Inflammatory rheumatic disease
• (4) Major neurological or psychiatric disease, Intellectual disability (mental retardation) or learning disorders at the premorbid level or severe language comprehension problems.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups

Pain Neuroscience Education

Experimental group

Description:

Pain neuroscience education in addition medical treatment. Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system.

Treatment:

Other: Pain Neuroscience Education

Other: Usual care

Usual care

Other 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.

Treatment:

Other: Usual care