Erosive Osteo-ArthritisADEPTNCT03919279
Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation
A study testing active tVNS in people with Erosive Osteo-Arthritis and Hand Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Erosive hand osteoarthritis (EHOA) is a subtype of had osteoarthritis characterized by inflammation and pain, with subsequent burden. Few symptomatic treatments are available in EHOA, while this population with EHOA has frequently comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Osteo-Arthritis, Hand Osteoarthritis
- What is being tested?
- active tVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2019to 16 Dec 2019
- 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 (1990 American College of Rheumatology criteria)
- EHOA according to hand radiographs with ≥1 erosive digital joints of proximal or distal interphalangeal joint (phases "E" or "R" of Verbruggen-Veys score)
- Visual Analogic Scale (VAS) for hand pain ≥ 40/100 at inclusion
- -≥1 interphalangeal joints symptomatic ≥ 3 months despite analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) (or contraindicated)
- ≥1 symptomatic interphalangeal joint with clinical palpable synovitis at inclusion
- Informed written consent
Who cannot join
- Isolated thumb-base OA (ie, rhizarthrosis)
- Hand osteoarthritis secondary to other known causes (eg gout, psoriatic arthritis)
- Psoriasis
- Current skin disease of the ear
- Ear canal not adapted to apply the auricular electrode
- History of severe cardiac disease (coronary artery disease, rhythm disturbance, heart failure, valvulopathy)
Show all 17Show fewer
- Conduction or rhythm disturbances on electrocardiogram
- Symptomatic orthostatic hypotension or vasovagal syncope history
- History of vagotomy
- Pregnancy
- Fibromyalgia
- Use of other electrically active medical devices (eg pacemaker)
- Documented sleep apnea
- Use of corticosteroid (oral, intramuscular, intra-articular or intravenous), immunosuppressive agents, hyaluronic acid injection in interphalangeal joint within the last 3 months
- Hand surgery planned during the study period
- Pregnancy or breastfeeding if applicable
- Oral NSAIDs consumption during the last 48 hours before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis
Erosive hand osteoarthritis (EHOA) is a subtype of had osteoarthritis characterized by inflammation and pain, with subsequent burden. Few symptomatic treatments are available in EHOA, while this population with EHOA has frequently comorbidities.
Stimulation of the vagus nerve (VN), 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). Beyond its anti-inflammatory effects, VNS is analgesic in chronic pain disorders (headache, fibromyalgia). Beside implantable devices, VNS may be performed using transcutaneous stimulation of the ascendant auricular branch of the VN (tVNS) at the left ear localized on the cymba conchae tVNS is well-tolerated therapy avoiding invasive neurosurgery.
The investigator do the hypothesis 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 EHOA.
Read the detailed description
In symptomatic and inflammatory EHOA patients, we will apply tNVNS using device from Schwa-Medico (TENSeco2 + auricular electrode + conductive gel) 25 Hz stimulation will be applied, intensity escalated up to 15 mA or below if tingling sensation.
tVNS will be performed 1 hour daily for 1 month and we will assess EHOA symptoms (pain and function) at 1 month (end of the study)
- Conditions
- Erosive Osteo-Arthritis, Hand Osteoarthritis
- Being tested
- active tVNS
- Keywords
- Erosive hand osteoarthritis, pain, inflammation, vagus nerve stimulation
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tVNSDevice
tVNS using TENS device from Schwa-Medico (TENSeco2) + auricular electrode applied on the left ear (Schwa-Medico) + conductive gel class I; 25 Hz stimulation 1 hour daily for 1 month
| Study group | Role | What they receive |
|---|---|---|
| active arm with active tVNS for 1 month | Experimental | Not described Receives: Device: active tVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Pain
Self-reported hand pain in the previous 48h measured on a 100 mm visual analogic scale (VAS).
Scoring system:
0= No pain 5= Moderate pain 10= Worst pain
Measured: 1 month
Secondary outcomes (4)
Function
questionnaire Functional Index for Hand OsteoArthritis (FIHOA): scale minimum 0 , and maximum 30.
Scoring system of the FIHOA:
0 = possible without difficulty
- = possible with slight difficulty
- = possible with important difficulty
- = impossible
Measured: 1 month
Side effect
Safety : report of side effects during the study period
Measured: 1 month
Mean time of daily use and cumulative time of use from the device's tracker
Observance : Mean time of daily use and cumulative time of use during the 30 days before the 1 month visit collected from the device's tracker
Measured: 1 month
Dose of daily consumption of paracetamol
Measure of Pain by daily consumption of paracetamol
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start29 May 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Osteo-ArthritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémie Sellam, MD PhD PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919279
- Sponsor's protocol ID
- APHP190156
- Acronym
- ADEPT
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT03919279
- Acronym / sponsor ID
- ADEPT / APHP190156
- Conditions
- Erosive Osteo-Arthritis, Hand Osteoarthritis
- Keywords
- Erosive hand osteoarthritis, pain, inflammation, vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 18 Apr 2019 (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 subtype of had osteoarthritis characterized by inflammation and pain, with subsequent burden. Few symptomatic treatments are available in EHOA, while this population with EHOA has frequently comorbidities.
Stimulation of the vagus nerve (VN), 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). Beyond its anti-inflammatory effects, VNS is analgesic in chronic pain disorders (headache, fibromyalgia). Beside implantable devices, VNS may be performed using transcutaneous stimulation of the ascendant auricular branch of the VN (tVNS) at the left ear localized on the cymba conchae tVNS is well-tolerated therapy avoiding invasive neurosurgery.
The investigator do the hypothesis 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 EHOA.
Detailed description
In symptomatic and inflammatory EHOA patients, we will apply tNVNS using device from Schwa-Medico (TENSeco2 + auricular electrode + conductive gel) 25 Hz stimulation will be applied, intensity escalated up to 15 mA or below if tingling sensation.
tVNS will be performed 1 hour daily for 1 month and we will assess EHOA symptoms (pain and function) at 1 month (end of the study)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active arm with active tVNS for 1 month | Experimental | Device: active tVNS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age≥18 years
- Symptomatic HOA (1990 American College of Rheumatology criteria)
- EHOA according to hand radiographs with ≥1 erosive digital joints of proximal or distal interphalangeal joint (phases "E" or "R" of Verbruggen-Veys score)
- Visual Analogic Scale (VAS) for hand pain ≥ 40/100 at inclusion
- -≥1 interphalangeal joints symptomatic ≥ 3 months despite analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) (or contraindicated)
Key exclusion criteria (17 listed)
- Isolated thumb-base OA (ie, rhizarthrosis)
- Hand osteoarthritis secondary to other known causes (eg gout, psoriatic arthritis)
- Psoriasis
- Current skin disease of the ear
- Ear canal not adapted to apply the auricular electrode
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 tVNStVNS using TENS device from Schwa-Medico (TENSeco2) + auricular electrode applied on the left ear (Schwa-Medico) + conductive gel class I; 25 Hz stimulation 1 hour daily for 1 month | Device | active arm with active tVNS for 1 month |
Primary outcome
Measure of Pain
Time frame: 1 month
Self-reported hand pain in the previous 48h measured on a 100 mm visual analogic scale (VAS). Scoring system: 0= No pain 5= Moderate pain 10= Worst pain
4 secondary outcomes
Function
Time frame: 1 month
Side effect
Time frame: 1 month
Mean time of daily use and cumulative time of use from the device's tracker
Time frame: 1 month
Dose of daily consumption of paracetamol
Time frame: 1 month
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 9 Apr 2020.
- Individual participant dataSharing planned: No
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, MD PhD PUPH 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 tVNS in people with Erosive Osteo-Arthritis and Hand Osteoarthritis, 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 7 inclusion and 17 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 9 Apr 2020. 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. 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?
Measure of Pain (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2020.