Fatigue in Sjögren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Change in fatigue score assessed
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Fatigue present for ≥ 6 months, without obvious explanation and/or specific treatment to conduct (e.g., disease's flare, chronic infection), with a current FACIT-F score < 34
Exclusion Criteria
- •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
- •People with dermatological problems in the area where the stimulation electrodes are to be placed
- •Current episode of venous or arterial thrombosis
- •Pregnancy or breastfeeding
- •Patient under protective measures (legal protection, curatorship, guardianship)
- •Inability or refusal to understand and/or sign informed consent to participate in the study, or to perform follow-up examinations required under the study
Arms & Interventions
APA + sham ACU + tVNS
Intervention: APA (adapted physical activity ) (Other)
APA + sham ACU + tVNS
Intervention: Transcutaneous Vagus Nerve Stimulation (tVNS) (Device)
APA + sham ACU + tVNS
Intervention: Acupuncture (sham_ACU) (Device)
APA + ACU + simulated tVNS
Intervention: Acupuncture (ACU) (Device)
APA + ACU + simulated tVNS
Intervention: APA (adapted physical activity ) (Other)
APA + ACU + simulated tVNS
Intervention: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) (Device)
APA + Simulated tVNS + sham ACU
Intervention: APA (adapted physical activity ) (Other)
APA + Simulated tVNS + sham ACU
Intervention: Acupuncture (sham_ACU) (Device)
APA + Simulated tVNS + sham ACU
Intervention: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) (Device)
Outcomes
Primary Outcomes
Change in fatigue score assessed
Time Frame: Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)
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)
Secondary Outcomes
- FACIT-F score in the different groups(between inclusion (Week 0) and week 48)
- Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)(at 12, 24 and 48 weeks,)
- Proportion (in %) of the 24 APA sessions carried out (at least 80% of the exercises proposed) in the different groups(week 48)
- ClinESSDAI score(at 12, 24 and 48 weeks,)
- ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)(at 12, 24 and 48 weeks)
- HADS questionnaire (Hospital Anxiety and Depression Scale)(at 12, 24 and 48 weeks)
- Self-measurement questionnaire SF-36 (Short Form Health Survey 36)(between inclusion (Week 0) and week 48)
- EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health(at 12, 24, and 48 weeks,)
- Schirmer test(at 12, 24 and 48 weeks)
- VO2max(at 12, 24 and 48 weeks)
- Handgrip test(at 12, 24 and 48 weeks)
- Number of daily steps(at 12, 24 and 48 weeks)