Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation

NCT03919279 | Completed

• 1 other identifier: APHP190156
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Erosive Osteo-Arthritis; Hand Osteoarthritis

Keywords

Erosive hand osteoarthritis; pain; inflammation; vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Secondary Outcomes (4)

• Function

  1 month

• Side effect

  1 month

• Mean time of daily use and cumulative time of use from the device's tracker

  1 month

• Dose of daily consumption of paracetamol

  1 month

Study Arms (1)

active arm with active tVNS for 1 month

EXPERIMENTAL

Device: active tVNS

Interventions

active tVNS DEVICE

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

active arm with active tVNS for 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• ≥1 interphalangeal joints symptomatic ≥ 3 months despite analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) (or contraindicated)
• Informed written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Rheumatology department Saint-Antoine Hospital

Paris, 75012, France

Location

MeSH Terms

Conditions

Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Jérémie Sellam, MD PhD PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: May 29, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)