Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

NCT04539171 | Completed

• 1 other identifier: FM001-BU-018
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Central Nervous System Sensitization; Chronic pain; Fibromyalgia; Neuroscience; Patient education

Outcome Measures

Primary Outcomes (1)

• 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: 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)

  Change from baseline to 12 months follow-up

Secondary Outcomes (7)

• Impact of fibromyalgia on daily life

  Change from baseline to 12 months follow-up

• Catastrophism

  Change from baseline to 12 months follow-up

• Anxiety

  Change in score from baseline to 12 months follow-up

• Depression

  Change in score of both subscales from baseline to 12 months follow-up

• Pain intensity

  Change from baseline to 12 months follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard of care.

Interventions

Pain Neuroscience Education and Physical Exercise OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Castilla-León Health Service: collaborator

Study Sites (1)

Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)

Burgos, Spain

Location

Related Publications (1)

• Areso-Boveda PB, Mambrillas-Varela J, Garcia-Gomez B, Moscosio-Cuevas JI, Gonzalez-Lama J, Arnaiz-Rodriguez 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.

  PMID: 35379222 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pilar San Teodoro-Blanco, MD

  Gerencia de Atención Primaria de Burgos. Castilla-León Health Service (Sacyl)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental, controlled, non-randomized study

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 4, 2020
• Study Start: January 15, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: At the time the study results are published.
• Access Criteria: Upon reasonable request after an individualized evaluation of each request by the research team.

Locations

ES (1)