Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-25

Study Completion Date

2018-10-08

Brief Summary

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Despite the large therapeutic arsenal available since one decade allowing a strong reduction of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher prevalence of non-inflammatory pain than general population. Fatigue is a real major problem due to 50% of patients considered it as severe.

This dissociation between disease activity and fatigue level suggests that fatigue is multifactorial. No consistent explanations for fatigue are currently available.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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high fatigue

Measure of ANS by VistaO2 device in Rheumatoid arthritis (RA) patients with low disease activity according to DAS28 \<3.2 with visual analog scale of fatigue is \> 5

Group Type OTHER

VistaO2

Intervention Type DEVICE

ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients

low fatigue

Measure of ANS by VistaO2 device in Rheumatoid arthritis (RA) patients with low disease activity according to DAS28 \<3.2 with visual analog scale of fatigue is \< or equal to 5

Group Type OTHER

VistaO2

Intervention Type DEVICE

ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients

Interventions

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VistaO2

ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* RA diagnosis according to ACR/EULAR 2010
* RA with low disease activity according to DAS28 \< 3.2
* Written consent obtained

Exclusion Criteria

* Other diagnosis than RA
* Depression known
* Hypertension treated or not,
* Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy,
* Pregnant or breastfeeding women,
* Inability to go two consecutive days at the North hospital for the delivery and return of the Vista02 device

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No