NCT05084300

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

March 18, 2021

Last Update Submit

February 27, 2023

Conditions

FibromyalgiaExecutive FunctionNeuroscience

Keywords

PainNeurophysiologyEducation

Outcome Measures

Primary Outcomes (4)

  • Change in Visual Analog Scale-Pain (EVA)

    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.

    at baseline and through intervention's completion, 5 weeks.

  • Change in Wisconsin card sorting test (WCST)

    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.

    at baseline and through intervention's completion, 5 weeks.

  • Change in Simon task

    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.

    at baseline and through intervention's completion, 5 weeks.

  • Change in Visual-spatial working memory span measured by Corsi Block-Tapping task

    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.

    at baseline and through intervention's completion, 5 weeks.

Secondary Outcomes (5)

  • 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.

Other Outcomes (2)

  • Change in Fibromyalgia Impact Questionnaire (FIQ)

    at baseline and through intervention's completion, 5 weeks.

  • Minimental State Examination Folstein

    at baseline and through intervention's completion, 5 weeks.

Study Arms (2)

Pain Neuroscience Education

EXPERIMENTAL

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.

Other: Pain Neuroscience EducationOther: Usual care

Usual care

OTHER

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.

Other: Usual care

Interventions

Pain Neuroscience EducationOTHER

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.

Also known as: Pain Neurophysiology Education
Pain Neuroscience Education
Usual careOTHER

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.

Pain Neuroscience EducationUsual care

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Artritis y Osteoporosis

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

Instituto Transdisciplinario de Rehabilitación (ITR)

Puebla City, 72410, Mexico

RECRUITING

Related Publications (1)

  • Morales-Osorio MA, Ramirez-Velez R, Mejia-Mejia J, Martinez-Martinez LA, Roman F, Lopez-Perez PJ, Ordonez-Mora LT. Efficacy of a pain neuroscience educational program in improving executive function and pain intensity in fibromyalgia patients (Fibrobrain project): Study protocol for a randomized controlled clinical trial. Contemp Clin Trials. 2024 Dec;147:107731. doi: 10.1016/j.cct.2024.107731. Epub 2024 Oct 31.

    PMID: 39486209DERIVED

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pedro J Lopez, PhD

    Doctorado en Neurociencia Cognitiva Aplicada, Universidad de la Costa

    STUDY DIRECTOR

Central Study Contacts

Marco A Morales-Osorio, PhD

CONTACT

+52 55 7984 0050maosorio@unap.cl

Fabian Román, PhD

CONTACT

+54 9 11 3586 5970faromanmd@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2021

First Posted

October 19, 2021

Study Start

April 15, 2023

Primary Completion

June 15, 2023

Study Completion

October 15, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)ME(1)