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Recruiting Not applicable

Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women

NCT07229976 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-03-20
Last updated
2026-10-27

Condition(s) studied

Chronic Insomnia During Perimenopause and Menopause

Investigational drug(s) / intervention(s)

thumbtack needleplacebo thumbtack needle

thumbtack needle: The treatment acupoints include bilateral Anmian Acupoint, bilateral Taichong acupoints, bilateral Neiguan acupoints, bilateral Sanyinjiao (SP6), and bilateral Zusanli (ST36) and Danzhong acupoints, a total of 11 acupoints. After 3 days of thumbtack needle retention, the patient went to the hospital where the doctor removed the thumbtack needle, disinfected the local skin, and received the next needle treatment. The patient received treatment twice a week (6 days) and rested for 1 day before continuing with the next treatment.

placebo thumbtack needle: The placebo thumbtack needle group selected acupoints that were the same as the thumbtack needle group. Bilateral sleeping acupoints, bilateral Taichong acupoints, bilateral Neiguan acupoints, bilateral Sanyinjiao (SP6), bilateral Zusanli (ST36), and Danzhong acupoints are all treated with comforting acupressure.where the doctor removed the placebo thumbtack needle, disinfected the local skin, and received the next placebo thumbtack needle needle. The patient received treatment twice a week (6 days) and rested for 1 day before continuing with the next treatment.

Study summary

A multicenter, randomized, controlled, blinded clinical trial was conducted to evaluate the effects of thumbtack needle on sleep in patients with chronic insomnia during perimenopause and menopause. Randomly divided into a treatment group and a control group using the central area method, with 99 patients in each group. The treatment group received thumbtack needle treatment, while the control group received placebo thumbtack needle treatment. The treatment course for both groups was 4 weeks.

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
65 Years
Healthy volunteers
No
Diagnostic criteria for perimenopause and menopause: * Perimenopausal period: a period of time from one year before the last menstrual period to the first year after the last menstrual period. Having at least one menstrual period in the past 12 months, or being under 55 years old, undergoing hysterectomy or endometrial ablation, but not bilateral oophorectomy; * Menopause: No menstruation in the past 12 months, or bilateral oophorectomy, or age 55 years or older, who has undergone hysterectomy or endometrial ablation; Diagnostic criteria for chronic insomnia: ●The diagnostic criteria for insomnia in the third edition of the International Classification of Sleep Disorders (ICSD-3) of the American Academy of Sleep Medicine (all criteria A to F must be met). Inclusion Criteria: * Women aged 40 to 65 who meet the diagnostic criteria for perimenopause and menopause mentioned above; * Evaluate ISI score ≥ 12 points through a scale; * Meets the diagnostic criteria for chronic insomnia mentioned above, i.e. ICSD-3 meets both criteria A to F; * Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: Patients who meet any of the following conditions will not be included; * Use hormone replacement therapy, anti anxiety drugs, antidepressants, or medications to improve insomnia within one month; * Individuals with a history of diagnosed sleep disorders before menopause; * Combined with other sleep disorders such as obstructive sleep apnea, restless leg syndrome, etc; * Patients with malignant tumors, especially estrogen dependent tumors (such as breast cancer and endometrial cancer); * Recent (within 6 months) history of myocardial infarction, stroke, venous thrombosis, etc; * Patients with mental illnesses, such as severe depression and uncontrolled schizophrenia; * Serious disorder of endocrine system, such as uncontrolled hyperthyroidism, diabetes ketoacidosis, etc * Patients with coagulation disorders, such as hemophilia, long-term use of anticoagulants (warfarin, aspirin, etc.), etc; * Long term alcohol consumption history (more than 5 years, daily alcohol consumption exceeding 12 taels, not quitting drinking); * Engaged in night shift work (\>3 times a week); * Individuals with infections, ulcers, burns, rashes, or scars at acupoints; * Previously received acupuncture treatment; * I do not agree to sign the informed consent form for this study.

Primary outcome measure(s)

  • Insomnia Severity Index — 4 weeks
    The Insomnia Severity Index (ISI) is a self-assessment tool used to evaluate the severity of insomnia. The ISI scale consists of 7 items, each rated on a scale of 0-4, with a total score range of 0-28 points. Evaluate the difference in scores between the Insomnia Severity Index (ISI) scale at the end of week 4 and baseline ISI scores.

Trial sites (8)

FacilityCityRegionStatus
Chibi Maternal and Child Health Hospital Chibi Hubei Recruiting
Jingzhou Hospital of Traditional Chinese Medicine Jingzhou Hubei Recruiting
Qianjiang Central Hospital Qianjiang Hubei Recruiting
Wuhan Children's Hospital Wuhan Hubei Recruiting
Renmin Hospital of Wuhan University Wuhan Hubei Recruiting
Rehabilitation Center, Wuhan Puren Hospital Wuhan Hubei Recruiting
Xiaogan Maternal and Child Health Care Hospital Wuhan Hubei Recruiting
Aksu Prefecture Maternal and Child Health Hospital Aksu XUAR Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07229976 on ClinicalTrials.gov ↗ ← All trials in China