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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
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.
Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)
Burgos, Spain
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)
Time frame: Change from baseline to 12 months follow-up
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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 12 months follow-up