Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Other: Pain Neuroscience Education and Physical Exercise
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 53
- 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.
- 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
- Arm && Interventions
Group Intervention Description Intervention Pain Neuroscience Education and Physical Exercise Pain neuroscience education (Health education) and Physical exercise program: 6 weekly sessions (2 hours each), and a reminder session one month later
- 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 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
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
Trial Locations
- Locations (1)
Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)
🇪🇸Burgos, Spain