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

Sponsor

National Yang Ming University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06129344

Collaborator

(none)

162

Enrollment

Location

Arms

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Engorgement Lactation Disorders	Other: Manual Lymphatic Drainage Group Other: Ultrasound therapy group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is a quasi-experimental randomized controlled trial using manual lymphatic drainage and ultrasound therapy as an intervention for breast swelling. Using computer-generated randomization of block assignment, block randomization of 3 size, and placing numbers in opaque envelopes, subjects were given three interventions, each subject receiving only one intervention . The intervention groups were divided into manual lymphatic drainage plus routine nursing group, therapeutic ultrasound plus routine nursing group, and control group (routine nursing only). In the intervention group, breast swelling, pain index and breast milk were measured repeatedly before and after treatment. The control group received usual care and recorded daily breast swelling, pain index and milk output.This study is a quasi-experimental randomized controlled trial using manual lymphatic drainage and ultrasound therapy as an intervention for breast swelling. Using computer-generated randomization of block assignment, block randomization of 3 size, and placing numbers in opaque envelopes, subjects were given three interventions, each subject receiving only one intervention . The intervention groups were divided into manual lymphatic drainage plus routine nursing group, therapeutic ultrasound plus routine nursing group, and control group (routine nursing only). In the intervention group, breast swelling, pain index and breast milk were measured repeatedly before and after treatment. The control group received usual care and recorded daily breast swelling, pain index and milk output.

Masking:

None (Open Label)

Masking Description:

Due to medical ethics, if there is related breast pain and discomfort, the medical staff will still relieve the patient's breast pain.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Experimental: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Experimental: 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.

Other: Ultrasound therapy group

Outcome Measures

Primary Outcome Measures

The Breast Enhancement Assessment Scale [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 [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 [Change from Baseline The Total Daily Milk Volume at 3day]
Total Daily Milk Volume was be recorded.

Secondary Outcome Measures

Increase breastfeeding rates [3day]
Continued breastfeeding was measured by the yes or no Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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