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Study on the Clinical Efficacy of Fu's Subcutaneous Needling in Treating Lactostasis

Observation on the Clinical Efficacy of Fu's Subcutaneous Needling in Treating Galactostasis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001716
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-05-10
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Lactostasis

Interventions

Control group:sham Fu's subcutaneous needling

Sponsors

Guangdong Provincial Second Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. The diagnostic criteria for traditional Chinese medicine (TCM) have been revised in accordance with the "Diagnostic and Therapeutic Standards for TCM Diseases and Syndromes" and "TCM Surgery" : 1)Obstruction of milk secretion obvious breast distension and pain presence or absence of breast lumps on the affected side visible or absent redness of the skin and may or may not be accompanied by systemic symptoms such as high fever chills thirst headache poor appetite constipation and irritability; 2) There may be or may not be chapped nipples on the affected side there may be dysfunction in milk excretion pain and distension in the affected breast local palpation or unpalpation of hard lumps in the affected breast visible or absent redness of the skin and may or may not be accompanied by systemic symptoms such as high fever chills thirst headache poor appetite constipation and irritability. A diagnosis can be made if either of items 1) or 2) is present. 2. The Western medical diagnostic criteria are revised in accordance with "Modern Breast Disease Diagnosis and Treatment" and the Chinese Guidelines for the Diagnosis and Treatment of mastitis during Lactation :1) Obstruction of the milk duct poor milk drainage or improper breastfeeding leading to milk accumulation; 2) There is local swelling and pain in the breast with a tender mass or thickened area palpable which is wedge-shaped or irregular in shape. The skin shows no obvious redness or swelling and the skin temperature may rise. It may or may not be accompanied by systemic symptoms such as fever and chills. 3) Blood routine test: The white blood cell count neutrophil count and the proportion of C-reactive protein are all not high. 3. Inclusion Criteria: 1) Individuals who meet the above-mentioned diagnostic criteria for both Chinese and Western diseases with only symptoms such as local breast swelling and pain and no systemic symptoms such as fever (body temperature < 37.5?) or chills; 2) The patient is in the lactation period aged between 20 and 45 years old and sought medical attention within 3 months of the onset of the disease. 3) Initial diagnosis and no relevant treatment for this disease; 4) Those who after fully understanding the treatment methods and risks of this study voluntarily participate in the study and sign the informed consent form; 5) The white blood cell count neutrophil count and the proportion of C-reactive protein in the blood routine were all not high. Breast ultrasound indicated no pus formation and a distinct mass could be palpated locally in the breast during physical examination.

Exclusion criteria

Exclusion criteria: 1)Those with concurrent mastitis and breast abscess; 2) There is a history of breast trauma or surgery in the corresponding area of milk stasis. 3) There are skin diseases such as macules papules erythema exfoliation trauma and ulceration at the operation site of the floating needle. 4) Those who are afraid of needles afraid of needles or unable to cooperate with relevant treatments; 5) Combined with breast diseases that may affect the observation of the therapeutic effect of this study such as: congenital dysplasia of the nipple history of breast fibroadenoma or tumor breast tuberculosis breast lipoma history of breast surgery breast duct tumor etc. 6) Concurrent diseases such as pneumonia and enteritis that may cause abnormal inflammatory indicators; Or patients with concurrent cardiovascular and cerebrovascular liver kidney and hematopoietic system diseases endocrine disorders and mental abnormalities. 7) Patients who suddenly developed other diseases or received other treatments on their own after inclusion which affected the evaluation of therapeutic effects; Those whose data collection before and after the study and experimental data are incomplete. All patients who meet any one of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Score of breast-feeding;

Secondary

MeasureTime frame
Threshold of pain;Visual analogue scale for pain;Breast swelling hardness score;breast thermometry;

Countries

China

Contacts

Public Contact?Qingtao He

Guangdong Provincial Second Hospital of Traditional Chinese Medicine

376302348@qq.com13711644123

Outcome results

None listed

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