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

NCT05084300 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Universidad de la Costa, Barranquilla, Colombia

    collaborator UNKNOWN
  • Instituto Transdisciplinario de Rehabilitación (ITR), Puebla, México

    collaborator UNKNOWN
  • Centro Mexicano Universitario de Ciencias y Humanidades (CMUCH), Puebla, México

    collaborator UNKNOWN
  • Centro de Artritis y Osteoporosis, Barranquilla, Colombia

    collaborator UNKNOWN
  • Instituto Neurociencia Del Dolor

    lead OTHER

Principal Investigators

  • Pedro J Lopez, PhD · Doctorado en Neurociencia Cognitiva Aplicada, Universidad de la Costa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2023-06-15
Completion
2023-10-15

Countries

  • Colombia
  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05084300 on ClinicalTrials.gov