NCT05084300

Effectiveness Pain Neuroscience Education In The Executive Functions In Patients With Fibromyalgia

Effectiveness Pain Neuroscience Education Program in the Executive Functions and Pain Intensity in Patients With Fibromyalgia.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Instituto Neurociencia Del Dolor · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia
• Executive Function
• Neuroscience

Interventions

Type	Name	Description
OTHER	Pain Neuroscience Education	A total of 10 PNE sessions (Neuroscience pain education) will be carried out, two each week in addition medical treatment similar to control group (Usual care). The NPE sessions will be conducted by an experienced NPE certified physical therapist in 35 minute face-to-face group sessions. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
OTHER	Usual care	The control group (Usual care) is treated with usual treatment, managment or medication for fibromyalgia, anxiolytics, antidepressants, analgesics. Depending on the medical needs and criteria of patients´s primary care physician.

Timeline

• Start date: 2023-04-15
• Primary completion: 2023-06-15
• Completion: 2023-10-15
• First posted: 2021-10-19
• Last updated: 2023-03-01

Locations

2 sites across 2 countries: Colombia, Mexico