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Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies

ConditionSjogren Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

Unexplained fatigue is a frequent (60-70%) chronic complaint in Sjögren's syndrome (SjS) with a clear unmet therapeutic need, despite the recommendation of adapted physical activity (APA) programs, which are effective and feasible, but only to some extent. Hence, other therapeutic approaches, such as Acupuncture (ACU) or transcutaneous vagal nerve stimulation (tVNS), have been evaluated during the past years, with varying degrees of success in alleviating fatigue.

FESSONA has been designed as a randomized controlled monocentric trial, aiming at comparing the effects of 3 different programs on fatigue in SjS: APA alone, APA+ACU and APA+tVNS. Relevant controls will be included as well (sham ACU and simulated tVNS).

Multiple fatigue and SjS-related features will be measured before (at inclusion) and after (week 12) the intervention, as well as at week 24 and 48, to evaluate the short- and long-term impact of each program. Tolerance and feasibility will also be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient affiliated or entitled to a social security scheme.

Age > 18 years.

Patient informed and having signed the information form and consent to participate in the study.

Patient with Sjögren's syndrome according to ACR/EULAR 2016 or AECG 2002 criteria, usually followed up every year or more frequently

Disqualifiers

Pre-existing atrial fibrillation or severe cardiac conduction disorders,

Recent stroke or myocardial infarction (<6 months),

Left ventricular ejection fraction <40% or severe heart failure (New York Heart Association functional class III or IV)

Recurrent episodes of vasovagal syncope, or history of vagotomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture (ACU)

    Device

    acupoints will be Baihui (GV20); Zhongwan (CV12), Guanyuan (CV4), bilateral Zusanli (ST36) bilateral Taichong (LV3). The needles will remain for 30 min. Subjects will receive acupuncture twice a week during the 12-week intervention.

  • Transcutaneous Vagus Nerve Stimulation (tVNS)

    Device

    Transcutaneous Vagus Nerve Stimulation (tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. In the groups receiving simulated tVNS, stimulation will be delivered to the ear lobe, which is devoid of vagal innervation. Stimulation will be delivered at a frequency of 20 Hz and a pulse width of 200 ms, while the stimulation amplitude will be individually titrated to 1 mA below the level that will lead to a mild unpleasant feeling, according to the parameters defined by Stavrakis et al (2017, 2020).

  • APA (adapted physical activity )

    Other intervention

    The APA (adapted physical activity ) program : 2 sessions of 90 min (with 60 min of aerobic exercise and 30 min of resistance exercises per session) per week, for 12 consecutive weeks

  • Acupuncture (sham_ACU)

    Device

    Needles well be used in the non-acupoint area 2 centimeters away from the real acupoints. The needles will remain for 30 min. Subjects will receive sham acupuncture twice a week during the 12-week intervention.

  • Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)

    Device

    Simulated Transcutaneous Vagus Nerve Stimulation (sim\_tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. NSVt devices will be used in "simulated" mode.

Treatment groups

174 Participants
are divided into 3 treatment groups
Group A: APA + sham ACU + tVNSExperimental treatment 3 interventions
Group B: APA + ACU + simulated tVNSExperimental treatment 3 interventions
Group C: APA + Simulated tVNS + sham ACUSham comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in fatigue score assessed

Change in fatigue score assessed using the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy - Fatigue; ranging from 0 to 52, 0 meaning extreme fatigue and 52 the total absence of fatigue)

Time frame
Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)

Secondary outcomes

1

FACIT-F score in the different groups

FACIT-F score at 48 weeks, in the different groups

Time frame
between inclusion (Week 0) and week 48
2

Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)

Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds), measured from a nocturnal ECG recording by Holter ECG, in the different groups

Time frame
at 12, 24 and 48 weeks,
3

Proportion (in %) of the 24 APA sessions carried out (at least 80% of the exercises proposed) in the different groups

Time frame
week 48
4

ClinESSDAI score

ClinESSDAI score (clinical part of the EULAR Sjögren's Syndrome Disease Activity Index; assessed on 11 "domains" corresponding to the main clinical manifestations of the disease; ranging from 0 to 135, a score of 0 meaning the existence of a disease and a score of 135 a disease whose activity would be maximal) in the different groups

Time frame
at 12, 24 and 48 weeks,

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Source ClinicalTrials.gov
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