Breast EngorgementNCT06129344
Lymphatic Drainage Versus Ultrasound for Postpartum Breast Engorgement: A Pilot Study
A study testing Manual Lymphatic Drainage Group and Ultrasound therapy group in people with Breast Engorgement and Lactation Disorders, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Engorgement, Lactation Disorders
- What is being tested?
- Manual Lymphatic Drainage Group and Ultrasound therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Autoimmune system problems
- physical and mental health problems
- Breast abscesses, mastitis
- Breast implants
- Cardiac pacemakers
- Malignant tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement in Postpartum Women: A Feasibility Pilot Study
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.
Read the 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.
- Conditions
- Breast Engorgement, Lactation Disorders
- Being tested
- Manual Lymphatic Drainage Group, Ultrasound therapy group
- Keywords
- breast engorgment, breast care, ultrasound therapy, breast feeding, manual lymphatic drainage, physical therapy modalities, postpartum
- Medical subject headings
- Lactation Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic Drainage GroupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Ultrasound therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline The Visual Analogue Scale for Pain；VASP at 3day
The Total Daily Milk Volume
Total Daily Milk Volume was be recorded.
Measured: Change from Baseline The Total Daily Milk Volume at 3day
Secondary outcomes (1)
Increase breastfeeding rates
Continued breastfeeding was measured by the yes or no Questionnaire
Measured: 3day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Jul 2024
Why it stopped: Recruitment was lower than the target 153 due to the pandemic, with only 35 participants. Four dropped out due to pandemic restrictions and health issues. The study will still proceed with analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast EngorgementStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ya-chun chang, Study chair, Researchers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129344
- Sponsor's protocol ID
- N202203042
- Status last verified
- Nov 2023
- First submitted
- 6 Jun 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement in Postpartum Women: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT06129344
- Acronym / sponsor ID
- N202203042
- Conditions
- Breast Engorgement, Lactation Disorders
- Keywords
- breast engorgment, breast care, ultrasound therapy, breast feeding, manual lymphatic drainage, physical therapy modalities, postpartum
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was lower than the target 153 due to the pandemic, with only 35 participants. Four dropped out due to pandemic restrictions and health issues. The study will still proceed with analysis.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage Group | Experimental | Other: Manual Lymphatic Drainage GroupManual 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 | Experimental | Other: Ultrasound therapy groupUltrasound 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Autoimmune system problems
- physical and mental health problems
- Breast abscesses, mastitis
- Breast implants
- Cardiac pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Lymphatic Drainage GroupManual 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 groupUltrasound 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 |
Primary outcome
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.
1 secondary outcome
Increase breastfeeding rates
Time frame: 3day
Results and safety
The study was stopped early (reason given: Recruitment was lower than the target 153 due to the pandemic, with only 35 participants. Four dropped out due to pandemic restrictions and health issues. The study will still proceed with analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ya-chun chang study chair
Researchers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic Drainage Group and Ultrasound therapy group in people with Breast Engorgement and Lactation Disorders, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was lower than the target 153 due to the pandemic, with only 35 participants. Four dropped out due to pandemic restrictions and health issues. The study will still proceed with analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Breast Enhancement Assessment Scale (time frame: Change from Baseline The Breast Enhancement Assessment Scale at 3day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.