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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Engorgement, Lactation Disorders

Intervention / Treatment
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* Other: Manual Lymphatic Drainage Group
* Other: Ultrasound therapy group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Lymphatic Drainage Group<br>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<br>* 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.<br>|
| Experimental: Ultrasound therapy group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| The Total Daily Milk Volume | Total Daily Milk Volume was be recorded. | Change from Baseline The Total Daily Milk Volume at 3day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase breastfeeding rates | Continued breastfeeding was measured by the yes or no Questionnaire | 3day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast engorgment, breast care, ultrasound therapy, breast feeding, manual lymphatic drainage, physical therapy modalities, postpartum