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Clinical Trials/NCT06129344
NCT06129344
Terminated
N/A

Comparative Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement in Postpartum Women: A Feasibility Pilot Study

National Yang Ming Chiao Tung University1 site in 1 country31 target enrollmentJuly 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Engorgement
Sponsor
National Yang Ming Chiao Tung University
Enrollment
31
Locations
1
Primary Endpoint
The Breast Enhancement Assessment Scale
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
July 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The Breast Enhancement Assessment Scale

Time Frame: Change from Baseline The Breast Enhancement Assessment Scale at 3day

There are six grades of breast swelling: grade 1: tender, the breast does not change; grade 2: slight change; grade 3: the breast feels thick without tenderness; grade 4: the breast feels thick and begins to pressure Pain; Grade 5: Thick breasts with obvious tenderness; Grade 6: Very hard and very painful.

The Visual Analogue Scale for Pain;VASP

Time Frame: Change from Baseline The Visual Analogue Scale for Pain;VASP at 3day

Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity.

The Total Daily Milk Volume

Time Frame: Change from Baseline The Total Daily Milk Volume at 3day

Total Daily Milk Volume was be recorded.

Secondary Outcomes

  • Increase breastfeeding rates(3day)

Study Sites (1)

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