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Effects of taVNS intervention on bone mass in postmenopausal women with low bone mass and its central mechanism

Correlation between bone mass metabolism and autonomic nerve function

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054483
Enrollment
Unknown
Registered
2021-12-18
Start date
2021-12-18
Completion date
Unknown
Last updated
2022-11-20

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

Conditions

osteopenia

Interventions

auricular acupuncture group:auricular acupressure
control group:sham taVNS

Sponsors

The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50-70 years, female subjects with natural menopause for more than 3 years; 2. After dual energy X-ray absorptiometry, -2.5 < T value < -1, which is in line with the diagnosis of low bone mass; 3. The subjects voluntarily participate in the research and sign the informed consent; 4. No contraindications for fMRI scanning, right-handed; 5. Able to understand the research content and cooperate to complete the research; 6. Have not received ear vagus nerve stimulation therapy or other physical therapy in the past 2 months; 7. Never had anti-osteoporosis treatment including calcium, VD, zoledronate, etc.

Exclusion criteria

Exclusion criteria: 1. History of metabolic bone disease (eg, hyperparathyroidism, hyperthyroidism, Cushing's syndrome, osteomalacia, liver and kidney failure, and diabetes). 2. Previous fractures or femoral head necrosis, and the examination site has a history of surgery or implants. 3. Inflammation and infectious diseases are not cured. 4. Long-term or current drinking, smoking, and drinking coffee and tea. 5. Long-term or current use of drugs known to affect bone metabolism (including bisphosphonates, calcium agents, estrogen and progesterone preparations, antiepileptic drugs, corticosteroids, thyroxine, anticoagulants, antiviral drugs, aromatase inhibitors, immunosuppressants, thiazolidinediones, etc.). 6. There are cardiovascular system diseases, endocrine system diseases, rheumatic immune diseases, neuropsychiatric diseases, malignant tumors, etc. (including arrhythmia, myocardial infarction, hypertension, coronary heart disease, diabetes, hyperthyroidism, hypothyroidism, rheumatoid arthritis, Crohn's disease, stroke, epilepsy, Parkinson's, insomnia, etc.). 7. Long-term or current use of drugs known to affect autonomic nerve function or cardiac function (including beta-blockers, angiotensin receptor antagonists, angiotensin-converting enzyme inhibitors, digoxin, anxiolytics). 8. There is a history of using tobacco, alcohol, tea, coffee, and energy drinks 24 hours before the inspection. 9. There is strenuous activity 24 hours before the examination. 10. Use antihistamines, hypnotics, sedatives, opioids, metformin, etc. 3 days before the examination. 11. Abnormal body temperature or use of antipyretic and analgesic drugs within 3 days before the examination. 12. The investigator believes that the patient has other conditions that are not suitable for participating in this study.

Design outcomes

Secondary

MeasureTime frame
heart rate variability;questionnaire;biomarker of bone metabolism;

Primary

MeasureTime frame
bone mineral density;brain fMRI;

Countries

China

Contacts

Public ContactLiu Bo
liubogzcm@163.com+86 13570112883

Outcome results

None listed

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