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

NCT07229976 | Not Yet Recruiting

• 1 other identifier: TJ-IRB202510056
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  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.

  4 weeks

Secondary Outcomes (23)

• Pittsburgh sleep quality index

  4 weeks

• Epworth Sleepiness Scale

  4 weeks

• Fatigue Severity Scale

  4 weeks

• Zung Self Rating Anxiety Scale

  4 weeks

• Zung Self Rating Depression Scale

  4 weeks

Study Arms (2)

thumbtack needle group

EXPERIMENTAL

The subject received thumbtack needle

Other: thumbtack needle

Placebo thumbtack needle group

OTHER

The subject received placebo thumbtack needle

Other: placebo thumbtack needle

Interventions

thumbtack needle 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.

thumbtack needle group

placebo thumbtack needle 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.

Placebo thumbtack needle group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-01