Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT04539171
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief 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.

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 Timeline

• Study Start: 2018-01-15
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-08
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study First Posted: 2020-09-04
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fulfillment of diagnostic criteria for fibromyalgia	Change from baseline to 12 months follow-up	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: 1. Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3-6 and SS scale score ≥9.; 2. Symptoms have been present at a similar level for at least 3 months.; 3. 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)

Secondary Outcome Measures

Name	Time	Method
Impact of fibromyalgia on daily life	Change from baseline to 12 months follow-up	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
Impact of pain in person's daily performance	Change from baseline to 12 months follow-up	Pain impact sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-70, with higher scores indicating worse outcome
Catastrophism	Change from baseline to 12 months follow-up	Pain-related catastrophizing behaviours and cognitions of individuals: Pain Catastrophizing Scale (PCS), which ranges from 0 to 52, with higher scores indicating worse outcome
Anxiety	Change in score from baseline to 12 months follow-up	Anxiety sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome
Depression	Change in score of both subscales from baseline to 12 months follow-up	Depression sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome
Pain intensity	Change from baseline to 12 months follow-up	Pain intensity sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-40, with higher scores indicating worse outcome
Functional capacity	Change from baseline to 12 months follow-up	Difficulty in performing activities of daily living: Health Assessment Questionnaire (HAQ), which ranges from 0 to 60, with higher scores indicating worse outcome

Trial Locations

Locations (1)

Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl); 🇪🇸 Burgos, Spain