Lymphatic Drainage Versus Ultrasound for Postpartum Breast Engorgement: A Pilot Study

NCT06129344 | Terminated DMC

• 1 other identifier: N202203042
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Engorgement; Lactation Disorders

Keywords

breast engorgment; breast care; ultrasound therapy; breast feeding; manual lymphatic drainage; physical therapy modalities; postpartum

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Increase breastfeeding rates

  3day

Study Arms (2)

Manual Lymphatic Drainage Group

EXPERIMENTAL

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

Ultrasound therapy group

EXPERIMENTAL

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

Interventions

Manual Lymphatic Drainage Group OTHER

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.

Manual Lymphatic Drainage Group

Ultrasound therapy group OTHER

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.

Ultrasound therapy group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

TMU-Joint Institutional Review Board

Taipei, Taiwan

Location

MeSH Terms

Conditions

Lactation Disorders; Breast Feeding

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Behavior

Study Officials

• ya-chun chang

  Researchers

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Typically, participants are unaware whether they are receiving experimental treatment or a control (e.g., standard care). The researchers and medical staff are aware of the treatment allocation. Due to medical ethics, if there is related breast pain and discomfort, the medical staff will still relieve the patient's breast pain.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: November 13, 2023
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: December 27, 2024

Record last verified: 2023-11

Locations

TW (1)