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A Traditional Chinese Medicine (TCM) Acupuncture Point Therapy Device Based on Bluetooth Communication Technology, Mid and Low-Frequency Electrical Combined with Heat Stimulation, for the Treatment of Primary Dysmenorrhea.

A low-frequency electrical and thermal stimulation acupuncture point therapy device based on Bluetooth communication technology for treating primary dysmenorrhea.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002634
Enrollment
Unknown
Registered
2025-12-30
Start date
2024-01-18
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Primary dysmenorrhea

Interventions

Electrical Stimulation Group:The Bluetooth medium-low frequency electrical stimulation therapy device electrode patches are adhered to acupoints, once daily, 15 minutes per session, for three consecut
Local Heat Application Group:Use a single-use self-heating patch once daily, remove after 15 minutes, for 3 consecutive menstrual cycles.
Electrical Stimulation Combined with Local Heat Therapy Group:Both the 'electrical stimulation group' and 'local heat' interventions are administered simultaneously.

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
14 Years to 45 Years

Inclusion criteria

Inclusion criteria: Meets the diagnostic criteria for primary dysmenorrhea: - Excludes organic diseases (e.g., endometriosis, uterine fibroids) through gynecological examination or ultrasound; - Experiences cyclic lower abdominal pain during menstruation, which may be accompanied by back pain, nausea, dizziness, etc.; - Pain occurs for at least three consecutive cycles. Menstrual regularity: - Menstrual cycle lasts 21–35 days, with menstruation lasting 3–7 days. Age range: - Generally, women aged 18–35 (or 18–40) who are unmarried or nulliparous. Pain severity meets research requirements: - Visual Analog Scale (VAS) score = 4 points (moderate to severe dysmenorrhea). No use of drugs or treatments affecting results: - No use of TENS, electroacupuncture, hormone therapy, oral contraceptives, or other long-term analgesics in the past three months. Voluntarily participates in the study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: Secondary dysmenorrhea or organic diseases: Such as endometriosis, adenomyosis, pelvic inflammation, cervical stenosis, uterine fibroids, etc. Use of medications or treatments that may affect dysmenorrhea: Those who have used hormones, intrauterine devices, oral contraceptives, or analgesics in the past 3 months. Individuals with implanted cardiac pacemakers or other electronic devices. (Contraindicated for TENS) Severe systemic diseases: Such as cardiovascular, neurological, hepatic or renal dysfunction, mental disorders, etc. Pregnant or breastfeeding women. Skin lesions or damaged/infection sites at electrode application areas. Individuals unable to cooperate with treatment or incomplete follow-up.

Design outcomes

Primary

MeasureTime frame
Menstrual Abdominal Pain Visual Analog Scale (VAS);Duration of dysmenorrhea;

Secondary

MeasureTime frame
Anxiety Self-Rating Scale;Depression Self-Rating Scale;Blood Prostaglandins;

Countries

China

Contacts

Public ContactWei Zhao Lian

The First Affiliated Hospital of Anhui Medical University

1123671571@qq.com+86 155 4343 8630

Outcome results

None listed

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