Completed

Effectiveness of a Group Intervention Through Education in Pain Neurophysiology and Exercise in Women With Fibromyalgia: a Quasi-experimental Study in Primary Care

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What is being tested

Pain Neuroscience Education and Physical Exercise

Other
Who is being recruted

Fibromyalgia+8

+ Muscular Diseases

+ Musculoskeletal Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2018
See protocol details

Summary

Principal SponsorMaimónides Biomedical Research Institute of Córdoba
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2018

Actual date on which the first participant was enrolled.

Objectives: To evaluate the effectiveness of a PNE and PE in patients with fibromyalgia (FM). 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.

Official TitleEffectiveness of a Group Intervention Through Education in Pain Neurophysiology and Exercise in Women With Fibromyalgia: a Quasi-experimental Study in Primary Care
NCT04539171
Principal SponsorMaimónides Biomedical Research Institute of Córdoba
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibromyalgiaMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPainRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsChronic Pain

Criteria

3 inclusion criteria required to participate
Women with FM (2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia)
Women ≥ 18 years
Agree to participate in the study and sign informed consent.
4 exclusion criteria prevent from participating
Oncological pain
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Pain neuroscience education (Health education) and Physical exercise program: 6 weekly sessions (2 hours each), and a reminder session one month later

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)

Burgos, SpainOpen Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl) in Google Maps
CompletedOne Study Center