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

NCT ID: NCT07229976

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2029-12-30

Brief 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.

Conditions

Chronic Insomnia During Perimenopause and Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

thumbtack needle group

The subject received thumbtack needle

Group Type: EXPERIMENTAL

thumbtack needle

Intervention Type: OTHER

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 group

The subject received placebo thumbtack needle

Group Type: OTHER

placebo thumbtack needle

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Dongmei Huang

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

TJ-IRB202510056

Identifier Type: -

Identifier Source: org_study_id