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Clinical Study of Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Patients with Gout

Clinical Study of Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Patients with Gout

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090435
Enrollment
Unknown
Registered
2024-09-30
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-10-07

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

Conditions

Gout

Interventions

Experimental group:Subjects assigned to the experimental group will use a transcutaneous electrical nerve stimulation (TENS) device for 30 minutes once daily.
Control group:Subjects randomized to the control group received sham stimulation using a transcutaneous electrical nerve stimulation (TENS) device for 30 minutes once daily.

Sponsors

Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subjects met the criteria for gout classification established by the American College of Rheumatology and the European League Against Rheumatism in 2015; 2. Individuals aged 18 to 70 years; 3. Those who voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant individuals (urine HCG positive) or those who are lactating. 2. Patients with pacemakers. 3. Recent use of anti-anxiety or antidepressant medications. 4. Patients with impaired consciousness, a history of mental illness, or those currently experiencing mental health issues. 5. Patients with skin sensitivity. 6. Patients with severe earlobe erosion or absence of the ear. 7. Patients who have undergone vagus nerve cutting and/or currently have implanted electrical or nerve stimulation devices. 8. A history of vasovagal syncope, significant cardiac arrhythmias, low blood pressure, or severe heart disease.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale;

Secondary

MeasureTime frame
Pittsburgh sleep quality index;Hamilton Depression Scale;Number of joint swelling and pain;Patient’s or Subjective Global Assessment Scale;Full blood cell count;CRP C-reactive protein;Erythrocyte sedimentation Rate;Cytokine;Uric acid;

Countries

China

Contacts

Public ContactPan Zhenglun

Department of Rheumatology

panzhenglun@126.com+86 532 6685 2734

Outcome results

None listed

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