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

Официальное название

Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women: A Multicenter Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое 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 con
• Другое 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 d

Первичные конечные точки

• Insomnia Severity Index [Срок оценки: 4 weeks]

Вторичные конечные точки (12)

• Pittsburgh sleep quality index [Срок оценки: 4 weeks]
• Epworth Sleepiness Scale [Срок оценки: 4 weeks]
• Fatigue Severity Scale [Срок оценки: 4 weeks]
• Zung Self Rating Anxiety Scale [Срок оценки: 4 weeks]
• Zung Self Rating Depression Scale [Срок оценки: 4 weeks]
• Sleep efficiency [Срок оценки: 2 weeks，4 weeks]
• wake-up time after sleep onset [Срок оценки: 2 weeks, 4 weeks]
• the number of awakenings per night [Срок оценки: 2 weeks, 4 weeks]
• The latent period of sleep onset [Срок оценки: 2 weeks, 4 weeks]
• Total sleep time [Срок оценки: 2 weeks, 4 weeks]
• the average wake-up time [Срок оценки: 2 weeks, 4weeks]
• Corticotropin-Releasing Hormone [Срок оценки: 4 weeks]

Критерии участия

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).

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07229976 · TJ-IRB202510056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗