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| Name | Class |
|---|---|
| Castilla-León Health Service | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Pain neuroscience education (Health education) and Physical exercise program: 6 weekly sessions (2 hours each), and a reminder session one month later |
|
| Control | No Intervention | Standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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) | Change from baseline to 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline to 12 months follow-up |
| Catastrophism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pilar San Teodoro-Blanco, MD | Gerencia de Atención Primaria de Burgos. Castilla-León Health Service (Sacyl) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl) | Burgos | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35379222 | Derived | Areso-Boveda PB, Mambrillas-Varela J, Garcia-Gomez B, Moscosio-Cuevas JI, Gonzalez-Lama J, Arnaiz-Rodriguez E, Del Barco MBA, Teodoro-Blanco PS. Effectiveness of a group intervention using pain neuroscience education and exercise in women with fibromyalgia: a pragmatic controlled study in primary care. BMC Musculoskelet Disord. 2022 Apr 4;23(1):323. doi: 10.1186/s12891-022-05284-y. |
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We plan to share IPD, upon reasonable request, at the time the data be published. We will share all IPD that underlie results in a publication.
At the time the study results are published.
Upon reasonable request after an individualized evaluation of each request by the research team.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Quasi-experimental, controlled, non-randomized study
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|
Pain-related catastrophizing behaviours and cognitions of individuals: Pain Catastrophizing Scale (PCS), which ranges from 0 to 52, with higher scores indicating worse outcome |
| 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 | 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 | 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 | 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 | 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 | Change from baseline to 12 months follow-up |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |