Effectiveness of a Group Intervention Through Education in Pain Neurophysiology and Exercise in Women With Fibromyalgia: a Quasi-experimental Study in Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Fulfillment of diagnostic criteria for fibromyalgia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
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: 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 Outcomes
- Impact of fibromyalgia on daily life(Change from baseline to 12 months follow-up)
- Impact of pain in person's daily performance(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)
- Functional capacity(Change from baseline to 12 months follow-up)