OsteoarthritisESTIVALNCT04520516
Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis
A study testing Active VAGUSTIM device in people with Osteoarthritis and Musculoskeletal Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Erosive hand osteoarthritis (EHOA) is a difficult-to-treat subtype of HOA characterized by local and systemic low-grade inflammation as well as by high level of pain and of disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Musculoskeletal Pain, Erosive Osteoarthritis
- What is being tested?
- Active VAGUSTIM device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Symptomatic HOA according to the American College of Rheumatology criteria
- Erosive HOA according to hand radiographs performed in routine practice showing ≥1 erosive digital joint based on Verbruggen-Veys scoring definition
- Hand pain level ≥ 40/100 mm on VAS at inclusion at least half of days of the 30 last days
- At least ≥1 symptomatic IP joint with clinical soft swelling or erythema at inclusion
- reported inadequate response or adverse effects or contraindication with existing medication (including acetaminophen, oral NSAIDs)
- Informed written consent
- Patient affiliated to a social security scheme NB: Clinical inflammation, ultrasound abnormalities and radiographic erosions have not have to be present in the same joint.
Who cannot join
- Isolated thumb-base OA (i.e., rhizarthrosis)
- Predominance of the pain in the thumb base rather than digital pain
- Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, Lyme disease)
- Psoriasis
- Current skin disease of the left ear (e.g., eczema, urticarial lesion, skin infection, external otitis)
- Ear canal not adapted to apply the auricular electrode
Show all 23Show fewer
- Known history of cardiac rhythm disturbances, atrio-ventricular block > first degree, or total bundle branch block
- Symptomatic orthostatic hypotension or repeated vasovagal syncope history
- History of vagotomy
- Severe Asthma
- Treated sleep apnea
- Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
- Fibromyalgia
- Use of other electrically active medical devices (e.g. pacemaker, TENS for chronic pain)
- Use of oral, intramuscular or intra-articular or intravenous steroids, other anti-synovial agents (e.g. slow-acting anti-rheumatic drugs such as methotrexate, sulfasalazine), intra-articular hyaluronic acid to the hand joints within the last 3 months
- Any new hand OA treatment in the previous 2 months, including physiotherapy and provision of new hand splint.
- Planned hand surgery in the next 3 months.
- Use of any investigational (unlicensed) drug within 3 months prior to screening.
- Evidence of serious uncontrolled concomitant medical condition, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, gastro-intestinal disease or epilepsy, which in the opinion of the investigator makes them unsuitable for the study
- Pregnant or breastfeeding woman
- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- Use of VNS before the study
- Use of NSAIDs or paracetamol less than 48h before the D0 visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis
Erosive hand osteoarthritis (EHOA) is a difficult-to-treat subtype of HOA characterized by local and systemic low-grade inflammation as well as by high level of pain and of disability.
Auricular transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic strategy that may reduce inflammation and pain level.
Read more
ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and safety of tVNS in patients with symptomatic and inflammatory EHOA.
tVNS will be performed using a transcutaneous electrical nerve stimulation (TENS) device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve.
The active and sham device's will display similar appearance but the sham one will not give electric signal.
Read the detailed description
Symptomatic hand osteoarthritis (HOA) affects 8-16% of the general population above 50 years and involves interphalangeal (IP) joints. HOA symptoms include pain, stiffness and are responsible for disability and substantial burden. Erosive HOA (EHOA) (10% prevalence among symptomatic HOA from the general population and 40-50% prevalence in tertiary centers) is the most severe HOA phenotype characterized by inflammatory flares, more IP joint destruction, pain, soft swelling joints (ie, synovitis), and more disability (similar to rheumatoid arthritis (RA)) than its non-erosive counterpart.
Current symptomatic pharmacological treatments of HOA or EHOA have a poor efficacy on pain (ie, paracetamol) or safety issues (ie, non-steroidal anti-inflammatory drugs (NSAIDs)) in this aging population with frequent comorbidities. Systemic and joint inflammation contribute to EHOA but 4 studies using TNF inhibitors, 2 using hydroxychloroquine, 1 using methotrexate and 1 using a new anti-IL1α/β failed to show any efficacy on pain in HOA or in EHOA. Therefore, innovative therapeutic approaches are awaited.
Stimulation of the vagus nerve (VNS), belonging to parasympathetic system, dampens pro-inflammatory cytokines production by splenic macrophages, through to the binding of acetylcholine neurotransmitter to α7nicotinic receptor on macrophages: this is the cholinergic anti-inflammatory pathway (CAP). VN stimulation (VNS) by cervical implantable device activating CAP has given promising results in refractory RA patients. Beyond its anti-inflammatory effects, VNS is analgesic in chronic pain disorders (headache, fibromyalgia). However, the use of such implantable device is limited by the need of cervical surgery and subsequent potential side effects.
Besides implantable devices, VNS may be also performed using transcutaneous VNS (tVNS) of the ascendant auricular branch of the VN that selectively innervates the cutaneous zone of cymba conchae at the left ear. Auricular tVNS avoids invasive neurosurgery and its potential side effects and is less expensive than implantable VNS, making it an attractive candidate for neurostimulation. Auricular tVNS has given positive results in chronic migraine and is currently tested in RA, Crohn's disease, widespread pain, irritable bowel syndrome and musculoskeletal pain related to systemic lupus.
We hypothesize that auricular tVNS using a transcutaneous electrical nerve stimulation (TENS) device could be a novel, simple and well-tolerated analgesic and anti-inflammatory treatment of symptomatic (i.e., painful) and inflammatory EHOA.
ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and the safety of tVNS in patients with symptomatic and inflammatory EHOA.
tVNS will be performed using an active or sham transcutaneous electrical nerve stimulation (TENS) device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve.
Exploratory and ancillary studies will include i) changes of serum biomarkers of inflammation and of cartilage degradation that will be assess at inclusion and at week 12 ii) hand MRI at W0 and W12 of the most symptomatic joint at inclusion for HOAMRIS socring at W0 and W12 for the center of Saint Antoine.
A phone call at D7± 3 days by the clinical research technician or the clinical nurse or the doctor who has performed the education during the D0 visit to check the proper use of the device.
- Conditions
- Osteoarthritis, Musculoskeletal Pain, Erosive Osteoarthritis
- Being tested
- Active VAGUSTIM device, Sham VAGUSTIM device
- Keywords
- Musculoskeletal pain, Osteoarthritis, Neuromodulation
- Medical subject headings
- Osteoarthritis, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active VAGUSTIM deviceDevice
Settings: 25 Hz stimulation, 100 microsec pulse width, intensity escalation up to 8 mA or below if tingling sensation, 20 min/day of stimulation in one daily session
Sham VAGUSTIM deviceDevice
The sham device : no electrical signal for VNS will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| tVNS active device | Experimental | VAGUSTIM device from Schwa-Medico Length of use : 12 weeks Receives: Device: Active VAGUSTIM device |
| Sham tVNS device | Sham comparator | Sham VAGUSTIM device from Schwa-Medico Length of use : 12 weeks Receives: Device: Sham VAGUSTIM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Day 0 to Week 12 of self-reported hand pain
Change from Day 0 to Week 12 of self-reported hand pain in the previous 48 hours measured on a 100 mm visual analogue scale (VAS) : "How much pain in your hands did you experience during the past 48 h?"
Measured: 12 weeks
Secondary outcomes (22)
AUStralian CANadian Osteoarthritis Hand Index (AUSCAN)(pain, function, stiffness).
AUStralian CANadian Osteoarthritis Hand Index (AUSCAN) 3.1 pain, function and stiffness subscores (for each subscore: 0-100 mm scale)
Measured: Between week 0 and week 12
Modified Functional Index for Hand OsteoArthritis (FIHOA)
scale minimum 0 , and maximum 30.
Measured: Between week 0 and week 12 vvv
Cochin Hand Function Scale.
Measured: Between week 0 and week 12
Percentage of patients below the Patient Acceptable Symptom State (PASS) of pain (VAS<40/100)
Measured: Between week 0 and week 12
EuroQoL EQ-5D.
Measured: Between week 0 and week 12
Hospital Anxiety and Depression Scale (HAD).
Measured: Between week 0 and week 12 vvvvvvv
Fatigue intensity on a 0-100 mm VAS
Measured: Between week 0 and week 12
Number of painful hand joints (0-30) under pressure.
Measured: Between week 0 and week 12
Number of swollen hand joints (0-30).
Measured: Between week 0 and week 12
Patient Global Assessment (PGA) of health status on a 0-100 mm VAS.
Measured: Between week 0 and week 12
DN-4 Questionnaire evaluating neuropathic pain.
Measured: Between week 0 and week 12
Change over time of VAS pain.
Measured: Week 0, Week 4, Week 8, and Week 12
Change over time of FIHOA.
Measured: Week 0, Week 4, Week 8, and Week 12
Change over time of AUSCAN (pain, stiffness, and function).
Measured: Week 0, Week 4, Week 8, and Week 12
Percentage of patients with symptom levels below which they consider their condition acceptable (PASS), defined by a VAS <40/100
Measured: Week 12
Proportion of OMERACT-OARSI responders.
Measured: Week 12
Percentage of responders according to the Patient Global Impression of Change (PGIC) score
Measured: Week 12
Total paracetamol consumption (g) divided by treatment duration using a patient-filled diary.
Measured: Between week 0 and week 12
Change in percentage in serum inflammatory or pain-related markers
Measured: Between week 0 and week 12
Change in serum cartilage degradation markers (Coll2-1 (a marker of type II collagen denaturation), Coll2-1-NO2).
Measured: Between week 0 and week 12
Proportion of side effects
report of side effects during the study period
Measured: 4 weeks, 8 weeks and 12 weeks
Average daily use duration and cumulative use duration of the Vagustim device since the last visit, collected from the device's tracking system before each visit.
Measured: Between week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start8 Apr 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Schwa medico (device lending)
- Responsible party
- Sponsor
- Investigators
- Jérémie SELLAM, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520516
- Sponsor's protocol ID
- APHP200014
- Acronym
- ESTIVAL
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2020
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Courties A, Tuffet S, Cormier G, Roux CH, Ornetti P, Pers YM, Gottenberg JE, Lespessailles E, Chapurlat R, Arniaud D, Rannou F, Wendling D, Eymard F, Mathieu S, Richette P, Saraux A, Marotte H, Poursac N, Rat AC, Bastard JP, Fellahi S, Henrotin Y, Minssen L, Deprouw C, Nguyen C, Touati A, Berard L, Rousseau A, Simon T, Maheu E, Berenbaum F, Sellam J. Transcutaneous auricular vagus nerve stimulation versus sham stimulation in patients with erosive hand osteoarthritis (ESTIVAL): a randomised, multicentre, double-blind, sham-controlled trial. Lancet Rheumatol. 2026 Feb;8(2):e98-e107. doi: 10.1016/S2665-9913(25)00226-7. Epub 2025 Dec 8.
PubMed 41380709Courties A, Deprouw C, Rousseau A, Berard L, Touati A, Kalsch J, Villevieille M, Maheu E, Miquel A, Simon T, Berenbaum F, Sellam J; ESTIVAL study group. Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial. BMJ Open. 2022 Mar 22;12(3):e056169. doi: 10.1136/bmjopen-2021-056169.
PubMed 35318234
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT04520516
- Acronym / sponsor ID
- ESTIVAL / APHP200014
- Conditions
- Osteoarthritis, Musculoskeletal Pain, Erosive Osteoarthritis
- Keywords
- Musculoskeletal pain, Osteoarthritis, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Schwa medico (device lending)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Erosive hand osteoarthritis (EHOA) is a difficult-to-treat subtype of HOA characterized by local and systemic low-grade inflammation as well as by high level of pain and of disability.
Auricular transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic strategy that may reduce inflammation and pain level.
ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and safety of tVNS in patients with symptomatic and inflammatory EHOA.
tVNS will be performed using a transcutaneous electrical nerve stimulation (TENS) device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve.
The active and sham device's will display similar appearance but the sham one will not give electric signal.
Detailed description
Symptomatic hand osteoarthritis (HOA) affects 8-16% of the general population above 50 years and involves interphalangeal (IP) joints. HOA symptoms include pain, stiffness and are responsible for disability and substantial burden. Erosive HOA (EHOA) (10% prevalence among symptomatic HOA from the general population and 40-50% prevalence in tertiary centers) is the most severe HOA phenotype characterized by inflammatory flares, more IP joint destruction, pain, soft swelling joints (ie, synovitis), and more disability (similar to rheumatoid arthritis (RA)) than its non-erosive counterpart.
Current symptomatic pharmacological treatments of HOA or EHOA have a poor efficacy on pain (ie, paracetamol) or safety issues (ie, non-steroidal anti-inflammatory drugs (NSAIDs)) in this aging population with frequent comorbidities. Systemic and joint inflammation contribute to EHOA but 4 studies using TNF inhibitors, 2 using hydroxychloroquine, 1 using methotrexate and 1 using a new anti-IL1α/β failed to show any efficacy on pain in HOA or in EHOA. Therefore, innovative therapeutic approaches are awaited.
Stimulation of the vagus nerve (VNS), belonging to parasympathetic system, dampens pro-inflammatory cytokines production by splenic macrophages, through to the binding of acetylcholine neurotransmitter to α7nicotinic receptor on macrophages: this is the cholinergic anti-inflammatory pathway (CAP). VN stimulation (VNS) by cervical implantable device activating CAP has given promising results in refractory RA patients. Beyond its anti-inflammatory effects, VNS is analgesic in chronic pain disorders (headache, fibromyalgia). However, the use of such implantable device is limited by the need of cervical surgery and subsequent potential side effects.
Besides implantable devices, VNS may be also performed using transcutaneous VNS (tVNS) of the ascendant auricular branch of the VN that selectively innervates the cutaneous zone of cymba conchae at the left ear. Auricular tVNS avoids invasive neurosurgery and its potential side effects and is less expensive than implantable VNS, making it an attractive candidate for neurostimulation. Auricular tVNS has given positive results in chronic migraine and is currently tested in RA, Crohn's disease, widespread pain, irritable bowel syndrome and musculoskeletal pain related to systemic lupus.
We hypothesize that auricular tVNS using a transcutaneous electrical nerve stimulation (TENS) device could be a novel, simple and well-tolerated analgesic and anti-inflammatory treatment of symptomatic (i.e., painful) and inflammatory EHOA.
ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and the safety of tVNS in patients with symptomatic and inflammatory EHOA.
tVNS will be performed using an active or sham transcutaneous electrical nerve stimulation (TENS) device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve.
Exploratory and ancillary studies will include i) changes of serum biomarkers of inflammation and of cartilage degradation that will be assess at inclusion and at week 12 ii) hand MRI at W0 and W12 of the most symptomatic joint at inclusion for HOAMRIS socring at W0 and W12 for the center of Saint Antoine.
A phone call at D7± 3 days by the clinical research technician or the clinical nurse or the doctor who has performed the education during the D0 visit to check the proper use of the device.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tVNS active device | Experimental | Device: Active VAGUSTIM deviceVAGUSTIM device from Schwa-Medico Length of use : 12 weeks |
| Sham tVNS device | Sham comparator | Device: Sham VAGUSTIM deviceSham VAGUSTIM device from Schwa-Medico Length of use : 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Symptomatic HOA according to the American College of Rheumatology criteria
- Erosive HOA according to hand radiographs performed in routine practice showing ≥1 erosive digital joint based on Verbruggen-Veys scoring definition
- Hand pain level ≥ 40/100 mm on VAS at inclusion at least half of days of the 30 last days
- At least ≥1 symptomatic IP joint with clinical soft swelling or erythema at inclusion
Key exclusion criteria (23 listed)
- Isolated thumb-base OA (i.e., rhizarthrosis)
- Predominance of the pain in the thumb base rather than digital pain
- Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, Lyme disease)
- Psoriasis
- Current skin disease of the left ear (e.g., eczema, urticarial lesion, skin infection, external otitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active VAGUSTIM deviceSettings: 25 Hz stimulation, 100 microsec pulse width, intensity escalation up to 8 mA or below if tingling sensation, 20 min/day of stimulation in one daily session | Device | tVNS active device |
| Sham VAGUSTIM deviceThe sham device : no electrical signal for VNS will be delivered. | Device | Sham tVNS device |
Primary outcome
Change from Day 0 to Week 12 of self-reported hand pain
Time frame: 12 weeks
Change from Day 0 to Week 12 of self-reported hand pain in the previous 48 hours measured on a 100 mm visual analogue scale (VAS) : "How much pain in your hands did you experience during the past 48 h?"
22 secondary outcomes
AUStralian CANadian Osteoarthritis Hand Index (AUSCAN)(pain, function, stiffness).
Time frame: Between week 0 and week 12
Modified Functional Index for Hand OsteoArthritis (FIHOA)
Time frame: Between week 0 and week 12 vvv
Cochin Hand Function Scale.
Time frame: Between week 0 and week 12
Percentage of patients below the Patient Acceptable Symptom State (PASS) of pain (VAS<40/100)
Time frame: Between week 0 and week 12
EuroQoL EQ-5D.
Time frame: Between week 0 and week 12
Hospital Anxiety and Depression Scale (HAD).
Time frame: Between week 0 and week 12 vvvvvvv
Fatigue intensity on a 0-100 mm VAS
Time frame: Between week 0 and week 12
Number of painful hand joints (0-30) under pressure.
Time frame: Between week 0 and week 12
Number of swollen hand joints (0-30).
Time frame: Between week 0 and week 12
Patient Global Assessment (PGA) of health status on a 0-100 mm VAS.
Time frame: Between week 0 and week 12
DN-4 Questionnaire evaluating neuropathic pain.
Time frame: Between week 0 and week 12
Change over time of VAS pain.
Time frame: Week 0, Week 4, Week 8, and Week 12
Change over time of FIHOA.
Time frame: Week 0, Week 4, Week 8, and Week 12
Change over time of AUSCAN (pain, stiffness, and function).
Time frame: Week 0, Week 4, Week 8, and Week 12
Percentage of patients with symptom levels below which they consider their condition acceptable (PASS), defined by a VAS <40/100
Time frame: Week 12
Proportion of OMERACT-OARSI responders.
Time frame: Week 12
Percentage of responders according to the Patient Global Impression of Change (PGIC) score
Time frame: Week 12
Total paracetamol consumption (g) divided by treatment duration using a patient-filled diary.
Time frame: Between week 0 and week 12
Change in percentage in serum inflammatory or pain-related markers
Time frame: Between week 0 and week 12
Change in serum cartilage degradation markers (Coll2-1 (a marker of type II collagen denaturation), Coll2-1-NO2).
Time frame: Between week 0 and week 12
Proportion of side effects
Time frame: 4 weeks, 8 weeks and 12 weeks
Average daily use duration and cumulative use duration of the Vagustim device since the last visit, collected from the device's tracking system before each visit.
Time frame: Between week 0 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 41380709Courties A, Tuffet S, Cormier G, Roux CH, Ornetti P, Pers YM, Gottenberg JE, Lespessailles E, Chapurlat R, Arniaud D, Rannou F, Wendling D, Eymard F, Mathieu S, Richette P, Saraux A, Marotte H, Poursac N, Rat AC, Bastard JP, Fellahi S, Henrotin Y, Minssen L, Deprouw C, Nguyen C, Touati A, Berard L, Rousseau A, Simon T, Maheu E, Berenbaum F, Sellam J. Transcutaneous auricular vagus nerve stimulation versus sham stimulation in patients with erosive hand osteoarthritis (ESTIVAL): a randomised, multicentre, double-blind, sham-controlled trial. Lancet Rheumatol. 2026 Feb;8(2):e98-e107. doi: 10.1016/S2665-9913(25)00226-7. Epub 2025 Dec 8.
- Derived from this study: PubMed 35318234Courties A, Deprouw C, Rousseau A, Berard L, Touati A, Kalsch J, Villevieille M, Maheu E, Miquel A, Simon T, Berenbaum F, Sellam J; ESTIVAL study group. Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial. BMJ Open. 2022 Mar 22;12(3):e056169. doi: 10.1136/bmjopen-2021-056169.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérémie SELLAM, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active VAGUSTIM device in people with Osteoarthritis and Musculoskeletal Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Day 0 to Week 12 of self-reported hand pain (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04520516, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.