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

Huazhong University of Science and Technology

Status

Not yet enrolling

Conditions

Chronic Insomnia During Perimenopause and Menopause

Treatments

Other: thumbtack needle

Other: placebo thumbtack needle

Study type

Interventional

Funder types

Other

Identifiers

NCT07229976

TJ-IRB202510056

Details and patient eligibility

About

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.

Enrollment

198 estimated patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.