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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2024-A02116-41 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APA + sham ACU + tVNS | Experimental |
| |
| APA + ACU + simulated tVNS | Experimental |
| |
| APA + Simulated tVNS + sham ACU | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program) |
| Measure | Description | Time Frame |
|---|---|---|
| FACIT-F score in the different groups | FACIT-F score at 48 weeks, 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin KILLIAN, MD | Contact | (33)477 82 91 79 | +33 | martin.killian@chu-st-etienne.fr |
| Florence RANCON, Chef de projet | Contact | (33)477829458 | +33 | florence.rancon@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Martin KILLIAN, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40546749 | Derived | Zhou X, Chen J, Colas C, Hupin D, Killian M. FatiguE in Sjogren's Syndrome: a randomised controlled trial of cOmbined Non-phArmacological therapeutic strategies (FESSONA). BMJ Open Sport Exerc Med. 2025 Jun 16;11(2):e002677. doi: 10.1136/bmjsem-2025-002677. eCollection 2025. |
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| 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 | 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. |
|
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
| 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 | 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 | at 12, 24 and 48 weeks, |
| ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index) | ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index); calculated as the mean of 3 self-measurement scales assessing fatigue, dryness and pain, each ranging from 0 to 10; 0 meaning the total absence of the symptom considered and 10 a symptom whose intensity would be at the maximum imaginable) in the different groups | at 12, 24 and 48 weeks |
| HADS questionnaire (Hospital Anxiety and Depression Scale) | HADS questionnaire (Hospital Anxiety and Depression Scale) composed of an anxiety score and a depression score both ranging from 0 to 21, 0 meaning the absence of symptoms of this type, and 21 the presence of an anxiety and/or major depressive state) in the different groups | at 12, 24 and 48 weeks |
| Self-measurement questionnaire SF-36 (Short Form Health Survey 36) | Self-measurement questionnaire SF-36 (Short Form Health Survey 36); comprising 36 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite) | between inclusion (Week 0) and week 48 |
| EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health | EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health (mobility, autonomy, daily activities, pain/discomfort and anxiety/depression) with 1 question per domain, with the possibility of choosing 5 degrees of severity each time (1 corresponding to no difficulty for the domain and 5 corresponding to the maximum degree of difficulty in the domain), the total of the 5 notes of the 5 domains giving a score ranging from 5 to 25, and this questionnaire is associated with a visual analogue scale (VAS) allowing the patient to rate his state of health of the day from 0 (the worst state of health imaginable) to 100 (the best state of health imaginable), in the different groups | at 12, 24, and 48 weeks, |
| Schirmer test | the area of the graduated blotter that became wet after 5 min of placement on the lower eyelid of each eye, expressed in millimeters and as the average of the two eyes) at 12, 24 and 48 weeks, in the different groups | at 12, 24 and 48 weeks |
| VO2max | VO2max (in ml/min/kg; after metabolic test) in the different groups | at 12, 24 and 48 weeks |
| Handgrip test | Handgrip test (in kg; via a grip test on the dominant upper limb) in the different groups | at 12, 24 and 48 weeks |
| Number of daily steps | Number of daily steps measured via a connected watch on average over the week preceding the assessments at 12, 24 and 48 weeks, in the different groups | at 12, 24 and 48 weeks |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D043384 | Glutamyl Aminopeptidase |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D000626 | Aminopeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045727 | Metalloexopeptidases |
| D045726 | Metalloproteases |
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