Clinical trial NCT06129344: Lymphatic Drainage Versus Ultrasound for Postpartum Breast Engorgement: A Pilot Study
Official title: Comparative Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement in Postpartum Women: A Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Engorgement
Lactation Disorders
Keywords: breast engorgment
breast care
ultrasound therapy
breast feeding
manual lymphatic drainage
physical therapy modalities
postpartum
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study assesses the effectiveness of manual lymphatic drainage and therapeutic ultrasound on postpartum breast engorgement, pain, and hardness. It explores these interventions' impact on psychosocial support for breastfeeding mothers and medical attention. The goal is to identify the most effective treatment and examine its acceptability among postpartum women. The research will evaluate the processes of participant recruitment, randomization, and outcome assessment to ensure proper implementation and anticipate challenges. Additionally, it will consider whether these interventions should be included in Taiwan's National Health Insurance benefits, focusing on their cost-effectiveness and potential clinical benefits to enhance maternal care quality.
Primary purpose: OTHER

Brief summary: In this article, women were randomly assigned to the manual lymphatic drainage group, therapeutic ultrasound group, and control group, and the breast pain, swelling hardness, and milk excretion before and after each treatment were measured.

Detailed description: Breast engorgement as the swelling and distention of breast, which is one of the most common problems of postpartum of 3-8 days. At the same time, the congested blood vessels and tissue fluid will enter the surrounding tissues, resulting in the retention of tissue fluid and blood, resulting in interstitial fluid. In cases such as interstitial edema, the flow of milk is restricted.

There are many conservative treatments for relieving breast swelling. At present, there have been published studies on the application of ultrasound therapy and manual lymphatic drainage to breast problems during lactation. Previous studies have shown that manual lymphatic drainage and ultrasound therapy can significantly improve the pain, temperature, and firmness of breast engorgement. Manual lymphatic drainage and ultrasound therapy have been widely used in physical therapy, but there is little empirical evidence for manual lymphatic drainage on breast swelling. It is hoped that this empirical medical research method can be used to reduce the effect of breast pain caused by breast problems and improve breast milk. The purpose of this study was to examine whether manual lymphatic drainage and ultrasound therapy can improve breast pain, breast swelling, and increase the flow and volume of milk removed.

Eligibility criteria: Inclusion Criteria:

* Over 20 years old
* Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth
* Able to read and understand Chinese
* At least four points on the Breast Swelling Scale

Exclusion Criteria:

* Autoimmune system problems
* physical and mental health problems
* Breast abscesses, mastitis
* Breast implants
* Cardiac pacemakers
* Malignant tumors

Primary outcomes:
measure: The Breast Enhancement Assessment Scale
timeFrame: Change from Baseline The Breast Enhancement Assessment Scale at 3day
measure: The Visual Analogue Scale for Pain；VASP
timeFrame: Change from Baseline The Visual Analogue Scale for Pain；VASP at 3day
measure: The Total Daily Milk Volume
timeFrame: Change from Baseline The Total Daily Milk Volume at 3day
Secondary outcomes:
measure: Increase breastfeeding rates
timeFrame: 3day
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: TMU-Joint Institutional Review Board
Study officials:
affiliation: Researchers
name: ya-chun chang
role: STUDY_CHAIR
References: