Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Pain Neuroscience Education and Physical Exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Burgos, Spain
    • Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Pain neuroscience education (Health education) and Physical exercise program: 6 weekly sessions (2 hours each), and a reminder session one month later	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.
No Intervention: Control; Standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Castilla-León Health Service
• Investigators: Principal Investigator: Pilar San Teodoro-Blanco, MD, Gerencia de Atención Primaria de Burgos. Castilla-León Health Service (Sacyl)

Publications and helpful links

General Publications

• Areso-Bóveda PB, Mambrillas-Varela J, García-Gómez B, Moscosio-Cuevas JI, González-Lama J, Arnaiz-Rodríguez 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Chronic pain; Fibromyalgia; Central Nervous System Sensitization; Neuroscience; Patient education
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: FM001-BU-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We plan to share IPD, upon reasonable request, at the time the data be published. We will share all IPD that underlie results in a publication.
• IPD Sharing Time Frame: At the time the study results are published.
• IPD Sharing Access Criteria: Upon reasonable request after an individualized evaluation of each request by the research team.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No