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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