Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

Maimónides Biomedical Research Institute of Córdoba

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Pain Neuroscience Education and Physical Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04539171

FM001-BU-018

Details and patient eligibility

About

This study evaluates the effects of a pain neuroscience education (PNE) and physical exercise (PE) program in women with fibromyalgia. The intervention group receives PNE and PE program supervised by a physiotherapist and a Family Doctor and the control group standard care, in primary care.

Full description

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.

Enrollment: 53 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: Pain Neuroscience Education and Physical Exercise

Control

No Intervention group

Description:

Standard of care.