Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649437
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2020-09-24
Brief Title:
Atrial Fibrillation Symptoms and Pain Sensitization
Sponsor:
Region Örebro County
Organization:
Region Örebro County
Study Overview
Official Title:
Pain Sensitization in Patients With Symptomatic Atrial Fibrillation Compared With Asymptomatic Patients
Status:
COMPLETED
Status Verified Date:
2021-02
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:
None
Brief Summary:
Atrial fibrillation AF is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades One third of patients with AF report no AF-associated symptoms but up to one fourth report severe symptoms such as chest pain It is well recognized but unclear why patients experience of AF-related symptoms including chest pain varies so much Patients with chronic pain show a high degree of central sensitization ie facilitated pain responses to repeated painful stimulation and impaired conditioned pain modulation compared with controls It is possible that patients with symptomatic AF may have developed pronounced pain sensitization even in the absence of chest pain as a symptom No previous study has investigated pain sensitization in patients with AF
The primary objective is to assess differences in pain sensitization in patients with symptomatic AF compared with patients with asymptomatic AF Secondary objectives are to study the association of age sex AF duration comorbidities and health-related quality of life to pain sensitization A total of 30 patients with permanent AF 15 symptomatic and 15 asymptomatic will be recruited Patients will complete an AF-specific symptom score and a generic health-related quality of life questionnaire and physicians will assess AF-related symptoms Quantitative sensory testing recordings will be collected by pressure algometry Assessment of temporal summation of pressure pain and conditioning pain modulation will be used to investigate the involvement of pain sensitization
This preliminary pilot study will be used to estimate sample size for a larger study in which both patients and control subjects will be recruited to further investigate whether patients with symptomatic AF have increased pain sensitization compared with patients with asymptomatic AF and controls The studies may have an impact on individualized management of patients with AF in the future
The primary objective is to assess differences in pain sensitization in patients with symptomatic AF compared with patients with asymptomatic AF Secondary objectives are to study the association of age sex AF duration comorbidities and health-related quality of life to pain sensitization A total of 30 patients with permanent AF 15 symptomatic and 15 asymptomatic will be recruited Patients will complete an AF-specific symptom score and a generic health-related quality of life questionnaire and physicians will assess AF-related symptoms Quantitative sensory testing recordings will be collected by pressure algometry Assessment of temporal summation of pressure pain and conditioning pain modulation will be used to investigate the involvement of pain sensitization
This preliminary pilot study will be used to estimate sample size for a larger study in which both patients and control subjects will be recruited to further investigate whether patients with symptomatic AF have increased pain sensitization compared with patients with asymptomatic AF and controls The studies may have an impact on individualized management of patients with AF in the future
Detailed Description:
None
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