Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05084300
Status:
RECRUITING
Last Update Posted:
2023-03-01
First Post:
2021-03-18
Brief Title:
Effectiveness Pain Neuroscience Education In The Executive Functions In Patients With Fibromyalgia
Sponsor:
Instituto Neurociencia Del Dolor
Organization:
Instituto Neurociencia Del Dolor
Study Overview
Official Title:
Effectiveness Pain Neuroscience Education Program in the Executive Functions and Pain Intensity in Patients With Fibromyalgia
Status:
RECRUITING
Status Verified Date:
2023-02
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:
PNE
Brief Summary:
Fibromyalgia FM is a chronic complex and disabling clinical entity that has an average global prevalence of 27 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 FM Usually non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality
Many studies have shown cognitive impairment in FM patients compared to control groups and FM patients mainly show problems with working memory processes and or in their attentional and executive domains as well as in speed of speech processing BD Dick Verrier Harker Rashiq 2008 Glass 2009 Tesio et al 2015 Williams Clauw Glass 2011
Many patients with FM have little understanding of their condition leading to maladaptive pain cognitions and coping strategies Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia This study aimed to explore the effectiveness of pain neuroscience education in patients with FM
Therefore this research aims to analyze the effectiveness of the neuroscience education program on pain in executive functions and the intensity of pain in patients with FM
Many studies have shown cognitive impairment in FM patients compared to control groups and FM patients mainly show problems with working memory processes and or in their attentional and executive domains as well as in speed of speech processing BD Dick Verrier Harker Rashiq 2008 Glass 2009 Tesio et al 2015 Williams Clauw Glass 2011
Many patients with FM have little understanding of their condition leading to maladaptive pain cognitions and coping strategies Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia This study aimed to explore the effectiveness of pain neuroscience education in patients with FM
Therefore this research aims to analyze the effectiveness of the neuroscience education program on pain in executive functions and the intensity of pain in patients with FM
Detailed Description:
The design of the present study will be a parallel-group randomized controlled trial that will be performed between september 2021 and march 2022
Total 62 patients Experimental PNE 31 Control Usal care 31 Experimental In individualized sessions to 31 patients a health professional will explain 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 brains ability to change patiens behaviour thanks to neuroplasticity
There will be 10 sessions of 35 minutes 2 times per week
Each week the contents of the class and other complementary materials will be sent to the patients
He outcomes will be assessed at baseline t1 and one week after intervention t2 Written informed consent will be acquired for all participants prior to their participation The study will be implemented and reported in line with the CONSORT statement
Total 62 patients Experimental PNE 31 Control Usal care 31 Experimental In individualized sessions to 31 patients a health professional will explain 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 brains ability to change patiens behaviour thanks to neuroplasticity
There will be 10 sessions of 35 minutes 2 times per week
Each week the contents of the class and other complementary materials will be sent to the patients
He outcomes will be assessed at baseline t1 and one week after intervention t2 Written informed consent will be acquired for all participants prior to their participation The study will be implemented and reported in line with the CONSORT statement
Study Oversight
Has Oversight DMC:
None
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?:
None