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NCT Number: NCT04539171

Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)

Burgos, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Fulfillment of diagnostic criteria for fibromyalgia

    Time frame: 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:

    • 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)

Secondary outcomes

  1. Impact of fibromyalgia on daily life

    Time frame: 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

  2. Catastrophism

    Time frame: 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

  3. Anxiety

    Time frame: 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

  4. Depression

    Time frame: 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

  5. Pain intensity

    Time frame: 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

  6. Impact of pain in person's daily performance

    Time frame: 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

  7. Functional capacity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Collaborators

  • Castilla-León Health Service

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2020
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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