Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT03947502
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2019-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Neuroscience Education as Treatment in Fibromyalgia Affected Patients
Sponsor:
Osatzen Sociedad Vasca Medicina Familiar y Comunitaria
Organization:
Study Overview
Official Title:
Effectiveness of a Structured Group Intervention Based on Pain Neuroscience Education for Patients With Fibromyalgia in Primary Care: a Multicenter Randomized Open-label Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia (FM) is a chronic, complex and disabling clinical entity that has an average global prevalence of 2.7%. It occurs mainly in women in a 3: 1 ratio. It is characterized by persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous systemic symptoms such as dizziness, migraine, digestive alterations or sensory intolerances. At present there is no pharmacological treatment with specific indication for fibromyalgia. Usually, non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality.
The investigator's main goal is to evaluate the effectiveness at 1 year of a group educational intervention in neurobiology of pain in patients affected by fibromyalgia, in comparison with the evolution of a control group that will continue only with its usual treatments. This intervention will be carried out in the field of Primary Care and its effectiveness will be assessed by reducing or not having diagnostic criteria (reduction of areas of pain and of the severity of fibromyalgia symptoms), using the Criteria for the Diagnosis of Fibromyalgia of the American College of Rheumatology 2010 (ACR 2010).
The investigator's main goal is to evaluate the effectiveness at 1 year of a group educational intervention in neurobiology of pain in patients affected by fibromyalgia, in comparison with the evolution of a control group that will continue only with its usual treatments. This intervention will be carried out in the field of Primary Care and its effectiveness will be assessed by reducing or not having diagnostic criteria (reduction of areas of pain and of the severity of fibromyalgia symptoms), using the Criteria for the Diagnosis of Fibromyalgia of the American College of Rheumatology 2010 (ACR 2010).
Detailed Description:
Methodology of the project In group sessions of 14 patients, a health professional explained the neurological mechanisms that are behind the perception of pain, fatigue and illness from the recent knowledge in neuroscience about brain and pain, as well as the brain's ability to change patien´s behaviour thanks to neuroplasticity.
There will be 5 sessions of 2 hours per week and another one per month. Before the latter, a workshop of 2 hours of movement will be given.
Each week the contents of the class and other complementary materials will be sent to the patients.
There will be 5 sessions of 2 hours per week and another one per month. Before the latter, a workshop of 2 hours of movement will be given.
Each week the contents of the class and other complementary materials will be sent to the patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: