Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539171
• Other study ID #: FM001-BU-018
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: August 2020
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)	Burgos

Sponsors (2)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fulfillment of diagnostic criteria for fibromyalgia	2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia: dichotomous variable (complies or does not comply). A patient satisfies diagnostic criteria for fibromyalgia if the following 3 conditions are met: Widespread pain index (WPI) =7 and symptom severity (SS) scale score =5 or WPI 3-6 and SS scale score =9.; Symptoms have been present at a similar level for at least 3 months.; The patient does not have a disorder that would otherwise explain the pain.; WPI: number of areas in which the patient has had pain over the last week (score between 0 and 19), with 0 = fully active and 5 = dead).; SS: sum of the severity of 3 symptoms (fatigue, waking unrefreshed, cognitive symptoms) plus the extent (severity) of somatic symptoms in general (final score between 0 and 12: higher scores mean a worse outcome)	Change from baseline to 12 months follow-up
Secondary	Impact of fibromyalgia on daily life	Evaluation of physical functionality, global impact and severity of symptoms: Fibromyalgia Impact Questionnaire (FIQ), which ranges from 0 to 100, with higher scores indicating worse outcome	Change from baseline to 12 months follow-up
Secondary	Catastrophism	Pain-related catastrophizing behaviours and cognitions of individuals: Pain Catastrophizing Scale (PCS), which ranges from 0 to 52, with higher scores indicating worse outcome	Change from baseline to 12 months follow-up
Secondary	Anxiety	Anxiety sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome	Change in score from baseline to 12 months follow-up
Secondary	Depression	Depression sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome	Change in score of both subscales from baseline to 12 months follow-up
Secondary	Pain intensity	Pain intensity sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-40, with higher scores indicating worse outcome	Change from baseline to 12 months follow-up
Secondary	Impact of pain in person's daily performance	Pain impact sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-70, with higher scores indicating worse outcome	Change from baseline to 12 months follow-up
Secondary	Functional capacity	Difficulty in performing activities of daily living: Health Assessment Questionnaire (HAQ), which ranges from 0 to 60, with higher scores indicating worse outcome	Change from baseline to 12 months follow-up