Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia
NCT ID: NCT04539171
Last Updated: 2020-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2018-01-15
2019-10-31
Brief Summary
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Detailed Description
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Design: Quasi-experimental, controlled, non-randomized study, in Primary Care facilities.
Intervention: 6 weekly sessions (2 hours each), and a reminder session one month later.
Main measurements: Compliance with FM criteria, assessed using the Widespread Pain Index (WPI) and the Severity of Symptoms (SS) questionnaires, impact of FM in daily life (Fibromyalgia Impact Questionnaire: FIQ) and quality of live. Assessments are made at baseline, one month following the 6th session, and during the 6- and 12-month follow-up.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Pain neuroscience education (Health education) and Physical exercise program: 6 weekly sessions (2 hours each), and a reminder session one month later
Pain Neuroscience Education and Physical Exercise
Patients assigned to the experimental group perform a PNE program consisting of seven sessions, with therapeutic PE. PNE is a health education intervention aims to provide up-to-date information on neuroscience advances in the field of chronic pain.
Control
Standard of care.
No interventions assigned to this group
Interventions
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Pain Neuroscience Education and Physical Exercise
Patients assigned to the experimental group perform a PNE program consisting of seven sessions, with therapeutic PE. PNE is a health education intervention aims to provide up-to-date information on neuroscience advances in the field of chronic pain.
Eligibility Criteria
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Inclusion Criteria
* Women ≥ 18 years
* Agree to participate in the study and sign informed consent.
Exclusion Criteria
* Motor control alteration that prevents the execution of the planned PE program
* Patients with associated pathologies that make it impossible to perform physical exercise program
* Any disabling mental illness or intellectual deficit that prevents understanding the contents of PNE program
18 Years
FEMALE
No
Sponsors
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Castilla-León Health Service
OTHER
Maimónides Biomedical Research Institute of Córdoba
OTHER
Responsible Party
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Principal Investigators
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Pilar San Teodoro-Blanco, MD
Role: PRINCIPAL_INVESTIGATOR
Gerencia de Atención Primaria de Burgos. Castilla-León Health Service (Sacyl)
Locations
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Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)
Burgos, , Spain
Countries
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References
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Areso-Boveda PB, Mambrillas-Varela J, Garcia-Gomez B, Moscosio-Cuevas JI, Gonzalez-Lama J, Arnaiz-Rodriguez E, Del Barco MBA, Teodoro-Blanco PS. Effectiveness of a group intervention using pain neuroscience education and exercise in women with fibromyalgia: a pragmatic controlled study in primary care. BMC Musculoskelet Disord. 2022 Apr 4;23(1):323. doi: 10.1186/s12891-022-05284-y.
Other Identifiers
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FM001-BU-018
Identifier Type: -
Identifier Source: org_study_id
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