Clinical trial NCT04649437: Atrial Fibrillation Symptoms and Pain Sensitization
Official title: Pain Sensitization in Patients With Symptomatic Atrial Fibrillation Compared With Asymptomatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Symptoms
Quality of Life
Pain
Conditioning pain modulation
Temporal summation
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2020-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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, i.e. 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.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 20 to 75 years old
* Permanent AF
* Previously completed AF-6
* Written informed consent

Exclusion Criteria:

* Paroxysmal or persistent AF
* Previous pulmonary vein isolation
* Psychiatric or cognitive condition
* Pregnancy
* Previous/current drug or alcohol abuse
* Previous neurological or concomitant musculoskeletal condition
* Continuous analgesic medication

Primary outcomes:
measure: Differences in pain sensitization
timeFrame: Day 1
Secondary outcomes:
measure: Correlation of age, sex, AF duration and comorbidities and HRQoL to pain sensitization
timeFrame: Day 1
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of cardiology
Study officials:
References:
citation: Jackson A, Frobert O, Boye Larsen D, Arendt-Nielsen L, Bjorkenheim A. Patients with symptomatic permanent atrial fibrillation show quantitative signs of pain sensitisation. Open Heart. 2021 Jun;8(1):e001699. doi: 10.1136/openhrt-2021-001699.