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Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation (ADEPT)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Erosive Osteo-Arthritis Hand Osteoarthritis | Device: active tVNS | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis |
| Actual Study Start Date : | May 29, 2019 |
| Actual Primary Completion Date : | December 16, 2019 |
| Actual Study Completion Date : | December 16, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: active arm with active tVNS for 1 month |
Device: active tVNS
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
|
- 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
- Function [ Time Frame: 1 month ]
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
- Side effect [ Time Frame: 1 month ]Safety : report of side effects during the study period
- Mean time of daily use and cumulative time of use from the device's tracker [ Time Frame: 1 month ]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
- Dose of daily consumption of paracetamol [ Time Frame: 1 month ]Measure of Pain by daily consumption of paracetamol
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
| France | |
| Rheumatology department Saint-Antoine Hospital | |
| Paris, France, 75012 | |
| Principal Investigator: | Jérémie Sellam, MD PhD PUPH | Assistance Publique - Hôpitaux de Paris |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 15, 2019 | ||||
| First Posted Date ICMJE | April 18, 2019 | ||||
| Last Update Posted Date | April 9, 2020 | ||||
| Actual Study Start Date ICMJE | May 29, 2019 | ||||
| Actual Primary Completion Date | December 16, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE |
Measure of Pain [ Time Frame: 1 month ] Self-reported hand pain in the previous 48h measured on a 100 mm visual analogic scale (VAS)
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation | ||||
| Official Title ICMJE | Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis | ||||
| Brief 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. 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. |
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| 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) |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: active tVNS
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
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| Study Arms ICMJE | Experimental: active arm with active tVNS for 1 month
Intervention: Device: active tVNS
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
20 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | December 16, 2019 | ||||
| Actual Primary Completion Date | December 16, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03919279 | ||||
| Other Study ID Numbers ICMJE | APHP190156 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | April 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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