Clinical trial for Chronic Low Back Pain
Official title Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain
ClinicalTrials.gov ID: NCT07681336
What this study is testing
- What it's testing
- This study checks if adding a wearable ear device to usual care reduces pain and improves daily function. It also looks at whether the device is safe and easy to use.
- Who it's for
- Adults aged 30 to 55 who have had moderate to severe low back pain for over 6 months and did not get enough relief from standard treatments.
- What's involved
- Participants will wear a small device on their ear that sends gentle electrical signals to a nerve. They will attend weekly visits for 6 weeks, keep a pain diary, and fill out questionnaires about their health and daily life.
- Time commitment
- The study involves 6 weeks of weekly visits followed by check-ins over the next 12 months to see long-term effects.
- Time commitment: about 12 months
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60
You may be able to join if
- Male or female patients aged ≥ 30 and ≤ 60 years;
- High impact lumbar or lumbosacral myofascial/musculoskeletal chronic (\> 6 months) low back pain that is moderate to severe (defined as average pain...
- Normal function of lumbosacral nerves based on clinical assessment;
- Unresponsive/intolerance (meaning insufficient pain reduction or intolerance) to oral pharmacotherapy (World Health Organization (WHO) grade II);
- ODI 21-80 at baseline;
You likely can't join if
- Organic low back pain (trauma, fracture, tumor, infection, documented severe degenerative spine, documented high-grade spinal stenosis, rheumatologic...
- Indication for back surgery;
- Radicular pain;
- New analgesics 2 weeks before baseline (paracetamol, NSAIDs, etc.);
- Opioid analgesic therapy;
- Underwent other physical therapy modalities, including TENS, ultrasound, infiltration, RF-treatment, 2 weeks before screening;
See the full eligibility criteria
- Male or female patients aged ≥ 30 and ≤ 60 years;
- High impact lumbar or lumbosacral myofascial/musculoskeletal chronic (\> 6 months) low back pain that is moderate to severe (defined as average pain over the last 4 weeks ≥ 5 on the NRS at baseline);
- Normal function of lumbosacral nerves based on clinical assessment;
- Unresponsive/intolerance (meaning insufficient pain reduction or intolerance) to oral pharmacotherapy (World Health Organization (WHO) grade II);
- ODI 21-80 at baseline;
- Patient understands the therapy and procedures, agrees to its provisions, and gives written informed consent prior to any procedures
- Organic low back pain (trauma, fracture, tumor, infection, documented severe degenerative spine, documented high-grade spinal stenosis, rheumatologic conditions);
- Indication for back surgery;
- Radicular pain;
- New analgesics 2 weeks before baseline (paracetamol, NSAIDs, etc.);
- Opioid analgesic therapy;
- Underwent other physical therapy modalities, including TENS, ultrasound, infiltration, RF-treatment, 2 weeks before screening;
- History of Vagus Nerve Stimulation or ear stimulation;
- History of vasovagal syncope;
- BMI \> 35 kg/m² (Obesity Class 2 or higher);
- Hemophilia;
- Documented autonomic disorders;
- Advanced stage or poorly controlled diabetes mellitus type I or II
- Poorly controlled high blood pressure at baseline (systolic blood pressure (SBP) \> 160 mmHg);
- Major psychiatric comorbidity (HADS ≥ 10 on each subscale at baseline);
- Other serious clinically relevant co-morbidity, florid malignant conditions or neurological diseases;
- History of arrhythmia, bradycardia, other rhythm disorders or any other clinically significant cardiac anomalies;
- Use of prescription blood thinners, e.g., oral anticoagulants (marevan, sintrom, marcoumar), noval oral anticoagulants (pradaxa, xarelto, eliquis, lixiana), anti-platelet medication (asaflow);
- Infection, eczema, or psoriasis at application site (ear and neck);
- Numbed and desensitized skin at the application site (ear and neck);
- Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse) in the last 6 months;
- Pregnant, parturient or breast-feeding women;
- Active implantable device (e.g. cardiac pacemaker, defibrillator, cochlear implant, neurostimulator like Spinal Cord Stimulation or Peripheral Nerve Stimulation) ;
- Currently participating in another treatment clinical trial or participated over the last 3 months;
- Patients who are unable to sufficiently speak and write in the Dutch language;
- Mental and physical impairments that represent a source of risk for handling the device;
- Patients under legal protection (curatorship, guardianship);
- Patients subject to a legal protection measure;
- An adult who is incapable or unable to give consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Ghent, Oost-Vlaanderen, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ghent, Oost-Vlaanderen, Belgium. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.