Clinical trial NCT05084300: Effectiveness Pain Neuroscience Education In The Executive Functions In Patients With Fibromyalgia
Official title: Effectiveness Pain Neuroscience Education Program in the Executive Functions and Pain Intensity in Patients With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Executive Function
Neuroscience
Keywords: Pain
Neurophysiology
Education
Lead sponsor: Instituto Neurociencia Del Dolor
Sponsor class: OTHER
Collaborators: name: Universidad de la Costa, Barranquilla, Colombia
name: Instituto Transdisciplinario de Rehabilitación (ITR), Puebla, México
name: Centro Mexicano Universitario de Ciencias y Humanidades (CMUCH), Puebla, México
name: Centro de Artritis y Osteoporosis, Barranquilla, Colombia
First posted: 2021-10-19
Enrollment: 62
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Visual Analog Scale-Pain (EVA)
timeFrame: at baseline and through intervention's completion, 5 weeks.
measure: Change in Wisconsin card sorting test (WCST)
timeFrame: at baseline and through intervention's completion, 5 weeks.
measure: Change in Simon task
timeFrame: at baseline and through intervention's completion, 5 weeks.
measure: Change in Visual-spatial working memory span measured by Corsi Block-Tapping task
timeFrame: at baseline and through intervention's completion, 5 weeks.
Secondary outcomes:
measure: Change in Stroop Color-word Task
timeFrame: at baseline and through intervention's completion, 5 weeks.
measure: Change in Central Sensitization Inventory Score (CSI)
timeFrame: at baseline and through intervention's completion, 5 weeks.
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: at baseline and through intervention's completion, 5 weeks.
measure: Change in Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: at baseline and through intervention's completion, 5 weeks.
measure: Change in Beck Depression Inventory Score
timeFrame: at baseline and through intervention's completion, 5 weeks.
Other outcomes:
measure: Change in Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: at baseline and through intervention's completion, 5 weeks.
measure: Minimental State Examination Folstein
timeFrame: at baseline and through intervention's completion, 5 weeks.
Locations:
city: Barranquilla
country: Colombia
facility: Centro de Artritis y Osteoporosis
state: Atlantico
city: Puebla
country: Mexico
facility: Instituto Transdisciplinario de Rehabilitación (ITR)
Study officials:
affiliation: Doctorado en Neurociencia Cognitiva Aplicada, Universidad de la Costa
name: Pedro J Lopez, PhD
role: STUDY_DIRECTOR
References: