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Atrial Fibrillation Symptoms and Pain Sensitization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649437
Recruitment Status : Completed
First Posted : December 2, 2020
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Anna Björkenheim, Region Örebro County

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diagnostic Test: Quantitative sensory testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Pain Sensitization in Patients With Symptomatic Atrial Fibrillation Compared With Asymptomatic Patients
Actual Study Start Date : November 26, 2020
Actual Primary Completion Date : January 14, 2021
Actual Study Completion Date : January 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Symptomatic patients
Subjects with symptoms of atrial fibrillation i.e. AF-6 sum score 30 points or more.
Diagnostic Test: Quantitative sensory testing
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
Subjects with no symptoms of atrial fibrillation i.e. AF-6 sum score = 0.
Diagnostic Test: Quantitative sensory testing
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.




Primary Outcome Measures :
  1. Differences in pain sensitization [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Correlation of age, sex, AF duration and comorbidities and HRQoL to pain sensitization [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649437


Locations
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Sweden
Department of cardiology
Örebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
Aalborg University
  Study Documents (Full-Text)

Documents provided by Anna Björkenheim, Region Örebro County:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Björkenheim, Principal investigator, Region Örebro County
ClinicalTrials.gov Identifier: NCT04649437    
Other Study ID Numbers: 274094
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study protocol, statistical analysis plan and informed consent form was shared with Dennis Boye Larsen and Lars Arendt Nielsen in Aalborg, Denmark in a meeting in person in September 2020. The clinical study report and encoded data regarding patient characteristics and results from questionnaires, body charts and quantitative sensory testing was shared with Dennis Boye Larsen and Lars Arendt Nielsen in Aalborg, Denmark, for statistical analysis. Data was made available by an encrypted usb flash drive sent by post. There is no other plan to make individual participant data available to other researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Björkenheim, Region Örebro County:
Atrial Fibrillation
Symptoms
Quality of Life
Pain
Conditioning pain modulation
Temporal summation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes