Fibromyalgia
Conditions
Keywords
Central Nervous System Sensitization, Chronic pain, Fibromyalgia, Neuroscience, Patient education
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.
Interventions
OTHERPain Neuroscience Education and Physical Exercise
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.
Sponsors
Castilla-León Health Service
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Quasi-experimental, controlled, non-randomized study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Spain
Outcome results
None listed