Effectiveness Pain Neuroscience Education Program in the Executive Functions and Pain Intensity in Patients With Fibromyalgia.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Instituto Neurociencia Del Dolor
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Change in Visual Analog Scale-Pain (EVA)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change in Visual Analog Scale-Pain (EVA)
Time Frame: at baseline and through intervention's completion, 5 weeks.
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.
Change in Wisconsin card sorting test (WCST)
Time Frame: at baseline and through intervention's completion, 5 weeks.
The WCST measures cognitive processes such as administrative control, characterization, perseveration, executive function, conceptualization, abstract thinking and reasoning, and it is mainly linked to frontal lobe . Commonly used neuropsychological computerized test to assess the ability to form abstract concepts, to shift and maintain set, and to utilize feedback. Total number of categories completed and perseverative errors (reported as t-score with range \<20 to \>80) will be reported. Higher values indicate better outcome.
Change in Simon task
Time Frame: at baseline and through intervention's completion, 5 weeks.
A cognitive task, assessing control processes under speeded conditions, measured by response time and accuracy rate. shorter response time and higher accuracy rate indicate better performance.
Change in Visual-spatial working memory span measured by Corsi Block-Tapping task
Time Frame: at baseline and through intervention's completion, 5 weeks.
The paradigm was computer-adaptive, and thus the set size would only increase if the participant passed consecutive two trials of the same span. The lowest span level started from 2 (2 squares that change color) and up to 9 as maximum.
Secondary Outcomes
- Change in Stroop Color-word Task(at baseline and through intervention's completion, 5 weeks.)
- Change in Central Sensitization Inventory Score (CSI)(at baseline and through intervention's completion, 5 weeks.)
- Change in Pain Catastrophizing Scale (PCS)(at baseline and through intervention's completion, 5 weeks.)
- Change in Tampa Scale for Kinesiophobia (TSK-11)(at baseline and through intervention's completion, 5 weeks.)
- Change in Beck Depression Inventory Score(at baseline and through intervention's completion, 5 weeks.)