Comparison of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement in Postpartum Women

Lactation Disorders Clinical Trial

Official title:

Comparison of the Effect of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement in Postpartum Women: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129344
• Other study ID #: N202203042
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: National Yang Ming University
• Contact: Li-Yin Chien
• Phone: +886 2-28267000
• Email: lychien[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Engorgement
• Hyperemia
• Lactation Disorders

Intervention

Other:
• Manual Lymphatic Drainage Group
Manual Lymphatic Drainage Group:Performed by physiotherapists trained by Dr. Vodder School and licensed in Lymphatic Consolidation Detoxification Therapy (CDT). The patient's treatment posture is to lie down. First, start with the neck lymphatic drainage technique. After performing bilateral axillary lymph node activation and lymphatic valve contraction, the bilateral breast lymph fluid is drained to the bilateral lymph nodes. The time is about 20 minutes. Assist in removing milk from both breasts for 15 minutes each. Once a day for three consecutive days of treatment.
• Ultrasound therapy group
Ultrasound therapy group: performed by a physical therapist. This study uses an ultrasonic therapy device (model: UTO US-750 Therapeutic Ultrasound), frequency: 1MHz, intensity set to 1.0 Watt/cm2, pulsed mode, duty cycle 100%, treatment time 2 5 minutes on each side, and then assist in removing the breast milk from both breasts for 15 minutes on each side. Once a day for three consecutive days of treatment.

Locations

Country	Name	City	State
Taiwan	TMU-Joint Institutional Review Board	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Breast Enhancement Assessment Scale	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.	Change from Baseline The Breast Enhancement Assessment Scale at 3day
Primary	The Visual Analogue Scale for Pain;VASP	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.	Change from Baseline The Visual Analogue Scale for Pain;VASP at 3day
Primary	The Total Daily Milk Volume	Total Daily Milk Volume was be recorded.	Change from Baseline The Total Daily Milk Volume at 3day
Secondary	Increase breastfeeding rates	Continued breastfeeding was measured by the yes or no Questionnaire	3day