Atrial Fibrillation Symptoms and Pain Sensitization

NCT04649437 | Completed DMC

• 1 other identifier: 274094
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Symptoms; Quality of Life; Pain; Conditioning pain modulation; Temporal summation

Outcome Measures

Primary Outcomes (1)

• Differences in pain sensitization

  A handheld pressure algometer will be used to assess the pressure pain thresholds over the sternum and the tibialis anterior muscle. Low pressure pain thresholds indicate sensitization. A pin prick will be used to induce temporal summation of pressure pain. Ten consecutive stimuli will be applied over the sternum and tibialis anterior muscle and the patient will be asked to rate the pain intensity on the visual analogue scale (minimum 0, maximum 10, higher scores mean worse pain). Temporal summation of pressure pain will be calculated as the difference in the pain intensity between the first and the last stimulation. High temporal summation of pressure pain scores indicate facilitated temporal summation. The conditioning pain modulation index will be assessed as the increase in pain pressure thresholds during cold pressure test. The lower the difference is, the more sensitization.

  Day 1

Secondary Outcomes (1)

• Correlation of age, sex, AF duration and comorbidities and HRQoL to pain sensitization

  Day 1

Study Arms (2)

Symptomatic patients

OTHER

Subjects with symptoms of atrial fibrillation i.e. AF-6 sum score 30 points or more.

Diagnostic Test: Quantitative sensory testing

Asymptomatic patients

OTHER

Subjects with no symptoms of atrial fibrillation i.e. AF-6 sum score = 0.

Diagnostic Test: Quantitative sensory testing

Interventions

Quantitative sensory testing DIAGNOSTIC_TEST

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.

Asymptomatic patients; Symptomatic patients

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead
• Aalborg University: collaborator

Study Sites (1)

Department of cardiology

Örebro, 70185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34140311 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Pain

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: December 2, 2020
• Study Start: November 26, 2020
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The encoded individual participant data is available for Dennis Boye Larsen and Lars Arendt Nielsen from 14th January 2021 to the end of march 2021.

Locations

SE (1)