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Mechanism of vagus nerve electrical stimulation to improve chronic low back pain

Mechanism of vagus nerve electrical stimulation to improve chronic low back pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092574
Enrollment
Unknown
Registered
2024-11-19
Start date
2024-08-25
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic low back pain

Interventions

Low back pain intervention group:Breath-gated taVNS treatment, total 20 minutes. A percutaneous electrical stimulation device is used to place special electrodes on the skin of the ear (auricle) to pr
Chronic low back pain control group:eRAVANS sham stimulation treatment, like the experimental group, wore all the stimulation equipment, coated the electrode with conductive gel and placed it on the e

Sponsors

The First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 18 and 65; 2) Self-reported clinical diagnosis of chronic low back pain (lumbosacral region); 3) Pain for at least 6 months; 4) According to the 0-10 Digital Rating Scale (NRS), the average daily pain rating was =4 points; 5) No history of neurological or mental illness, and no current stable medical condition

Exclusion criteria

Exclusion criteria: 1) Oral analgesics such as paracetamol and NSAID; 2) New use of analgesics in the past 2 weeks; 3) History of external ear pain, trauma and skin disease; 4) History of facial pain; 5) Use of metal implants (including pacemakers); 6) Special conditions such as pregnancy, history of heart disease (arrhythmia, coronary heart disease), history of neurological diseases (including convulsions or seizures), etc.; 7) History of moderate to major depression (HDRS score =17); 8) History of vasovagal syncope; 9) Skin, alcohol and drug metal allergy history dependence.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;EEG;Physical examination and vital signs;

Secondary

MeasureTime frame
Pain perception threshold;Brain function monitoring;Pain empathy test;Demographic index;Pulmonary function test;Ultrasonic measurement of diaphragm thickness and mobility;

Countries

China

Contacts

Public ContactChuhuai Wang

The First Affiliated Hospital, Sun Yat-Sen University

wangchuh@mail.sysu.edu.cn+86 133 1619 1023

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026