SENECA - Smart Therapies for Chronic Pain

NCT ID
NCT07628179
Registry status
Not yet recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
Aurimod GmbH

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 44 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Male or female aged between 30 and 65 years * Indication: chronic myofascial/musculoskeletal back pain * normal function of spinal nerves * Intractable pain for more than 6 months * Patient on oral pharmacotherapy ≤ WHO II with no adequate response or intolerant * Average pain over the last 4 weeks according to the 0-10 numerical pain rating scale ≥ 4 and ≤ 9 at baseline * ODI 20-80 at baseline * Basic digital understanding to work with the patient pain app * Patient understands the therapy and procedures, agrees to its provisions, and gives written informed consent prior to any procedures Exclusion Criteria: * Organic low back pain (trauma, fracture, tumor, infection, severe degenerative spine, documented high-grade spinal stenosis, rheumatologic conditions) * Indication for back surgery * Back surgery within the last 6 months * New analgesics 2 weeks before baseline (paracetamol, NSAIDs, Metamizol, etc.) * Opioid analgesic therapy \> WHO II * New physical therapy modalities for back pain, also TENS, 2 weeks before baseline * History of vagus nerve stimulation or electrical auricular stimulation * History of vasovagal syncope * High BMI \> 35 kg/m² (Obesity Class 2 or higher) * Hemophilia * Autonomic disorders * Advanced stage or poorly controlled diabetes mellitus type I or II * Poorly controlled high blood pressure * Major psychiatric comorbidity (HADS \> 10 on each subscale at baseline) * Other serious clinically relevant co-morbidity * History of arrhythmia, bradycardia, other rhythm disorders or any other clinically significant cardiac anomalies * Infection, eczema, or psoriasis at application site (ear and neck) * Numbed and desensitized skin at the application site (ear and neck) * Chronic drug or alcohol abuse within the last 6 months * Pregnant or nursing female patients * Active implantable device * Open pension request * Currently participating in another clinical trial or participated over the last 3 months * Change in concomitant treatment or medication during the study

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Austria

  • Carinthia, Austria: 1

Sample of listed locations

  • Klinikum Klagenfurt am Wörthersee — Klagenfurt, Carinthia, 9020, Austria — Site recruitment status not specified in the registry data

Study details

Start date
September 17, 2026
Primary completion date
March 31, 2027
First posted
June 4, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07628179
Registry last updated
August 31, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07628179 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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