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Clinical evaluation and mechanism of "Shu Mu point combination" acupuncture in the treatment of insomnia after breast cancer surgery

Clinical evaluation and mechanism of acupuncture based on "Shu Mu point combination" in the treatment of postoperative insomnia in patients with breast cancer - Clinical Effect and Mechanism of "Shu Mu Combined Points" Acupuncture on Insomnia after breast cancer Operation

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082110
Enrollment
Unknown
Registered
2024-03-21
Start date
2023-07-20
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, insomnia

Interventions

Acupuncture group:Acupuncture operation: The patient is placed in a supine position, and after routine disinfection with 75% medical alcohol, 0.25 is used × 25mm 0.25 × 40mm (Andy, Guizhou, China) mil
Sleeping Stab 1-1.5 inches. After receiving acupuncture at the above acupoints, the qi is replenished and reduced. Heart Shu, Kidney Shu, and Liver Shu oblique needling 0.5 to 0.8 inches. The Tu Xing
At the same time, the operation technique of light insertion and heavy lifting is adopted. Shenshu and Jingmen adopt the tonifying method of the twisting and tonifying reduction technique, which is ch
At the same time, the operation technique of heavy insertion and light lifting is adopted. All acupuncture points are left with needles for 20 minutes. Five acupuncture and moxibustion with 3-10 years

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for insomnia in breast cancer patients with yin deficiency and fire hyperactivity (1) Women aged = 18 years and = 75 years; (2) Patients diagnosed with primary breast malignant tumors have a clinical stage of I-III; (3) Prior to enrollment, corresponding radiotherapy, chemotherapy, or surgical treatment has been completed for at least 3 months, except for endocrine targeted therapy. (4) Meets the diagnostic criteria for chronic insomnia in ICSD-3; (5) Insomnia symptoms begin to appear within one week after surgery; (6) The traditional Chinese medicine syndrome differentiation is divided into yin deficiency and excessive fire type; (7) ISI>7 points (clinically significant insomnia); (8) It is allowed to take sleeping related drugs (barbiturates, chloral hydrate, tribromine mixture and hydroxyzine, benzodiazepine sedative and hypnotic drugs, zolpidem, zaleplon, zopiclone), and participants are not allowed to increase or change medication without consent during the study period. Throughout the entire study process, adjustments to medication and sleeping aids need to be notified to the researchers for detailed records; (9) Volunteer to participate in this project and sign an informed consent form. 2. Inclusion criteria for subjects undergoing multifunctional magnetic resonance imaging (fMRI) scanning (1) Meet all the criteria in 4.1, that is, meet the inclusion criteria for insomnia patients after breast cancer surgery with yin deficiency and fire hyperactivity; (2) Right-handed; (3) No organic brain lesions; (4) No contraindications for magnetic resonance imaging (such as metal implants, claustrophobia, etc.). (5) Within the first 3 months of entering this study, no sedative or hypnotic drugs were taken, and similar drugs and health products cannot be taken on their own during treatment and follow-up; (6) Volunteer to conduct a total of 2 multi-functional magnetic resonance scans and sign an informed consent form. 3. Inclusion criteria for healthy subjects (1) Women aged = 18 and = 75 years old; (2) Diagnosed and ruled out having tumors and tumor related complications; (3) Right-handed; (4) No system dysfunction; (5) No organic brain lesions; (6) No underlying diseases; (7) No bad habits such as smoking, drinking, special sleep, and eating; (8) No contraindications for magnetic resonance imaging (such as metal implants, claustrophobia, etc.); (9) ISI = 7 points (insomnia without clinical significance); (10) Voluntarily conduct a total of 1 multi-functional magnetic resonance imaging scan and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for insomnia patients after breast cancer surgery (1) Merge with other tumors; (2) Severe heart, liver, kidney, blood, respiratory system and other diseases; (3) Diagnosed as a mental illness patient according to the "Manual for Diagnosis and Statistics of Mental Disorders"; (4) Other types of sleep disorders, such as sleep apnea and restless legs syndrome (PSG shows sleep apnea hypopnea = 10/h or PSG shows periodic limb movements>15 times/h); Sleep disorders among shift workers; (5) Pregnant or lactating women; (6) Infectious diseases; (7) Those whose breast skin is broken to the point that they cannot accept acupuncture and moxibustion treatment; (8) Those who are afraid of needles or feel dizzy; (9) Participated in other projects within the past 3 months; (10) Severe visual, auditory, or language impairments; Individuals with unhealthy lifestyle habits such as alcohol or drug abuse; 2. Exclusion criteria for healthy subjects (1) Diagnosed as a mental illness patient according to the "Manual for Diagnosis and Statistics of Mental Disorders"; (2) Pregnant or lactating women; (3) Patients with infectious diseases; (4) Severe visual, auditory, or language impairments; Individuals with unhealthy lifestyle habits such as alcohol or drug abuse; (5) Other types of sleep disorders, such as sleep apnea, restless leg syndrome, and sleep disorders in shift workers; (6) Emotional disorders and lack of cooperation. (7) I have participated in other projects in the past 3 months.

Design outcomes

Primary

MeasureTime frame
ISI;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index,PSQI;polysomnography,PSG;Sleep Diary;Beck Anxiety Inventory,BAI;Beck Depression Inventory-II,BDI-II;fatigue score measured by the Chinese version of the Brief Fatigue Inventory,BFI-C;Functional Assessment of Cancer Therapy-Breast ,FACT-B;Traditional Chinese Medicine Syndrome Scale; CEA;estrogen;

Countries

China

Contacts

Public ContactChenYunfei

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

icyf1968@163.com+86 139 1792 2206

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026