Continuous ultrasound diathermy combined with conventional therapies versus conventional therapies alone for breast engorgement in postpartum lactating women: a randomized controlled study

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20181123001

Enrollment

Registered

2018-11-23

Start date

2018-11-08

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate postpartum breast engorgement Postpartum blocked duct Breastfeeding patients Pain management Engorgement Level of difficulty breastfeeding Duration of breastfeeding Immediate postpartum breast engorgement Postpartum blocked duct Breastfeeding patients Pain management Engorgement Level of difficulty breastfeeding Duration of breastfeeding Ultrasound diather

Interventions

Continuous ultrasound diathermy&#44

1mHz&#44

Intensity (adjusted to proper warm sensation)&#44

duration 8&#45

16 minutes,not operating ultrasound diathermy device

Experimental Device,Sham Comparator Device

Continuous ultrasound diathermy combined with conventional therapies,Controlled combined with conventional therapies

Eligibility

Sex/Gender

Female

Age

15 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Breastfeeding patients 2. Postpartum breast engorgement and blocked duct (diagnosed by latational specialist nurses)

Exclusion criteria

Exclusion criteria: 1. Mastitis/ Breast abscess/ Abnormal ultrasound findings suggest malignancy (excluded by diagnostic breast ultrasound by radiologist) 2. Family history of breast cancer (first degree) 3. Previous history of breast implant or augmentation 4. Accessory breast 5. History of previous ultrasound diathermy treatment 6. Impaired sensation in breast area 7. Impaired Thai language communication

Design outcomes

Primary

Measure	Time frame
The level of Pain Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Visual analog scale (millimeter)	—

Secondary

Measure	Time frame
Hardness Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Visual analog scale (millimeter), rated by patient,Level of difficulty breastfeeding Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Visual analog scale (millimeter), rated by patien,Breast engorgement severity (assessed by physician ) Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Humenick Six-point engorgement scale ,Duration of breastfeeding post treatment days,Complication: mastitis, breast abscess post treatment number of complication	—

Measure

Time frame

Hardness Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Visual analog scale (millimeter), rated by patient,Level of difficulty breastfeeding Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Visual analog scale (millimeter), rated by patien,Breast engorgement severity (assessed by physician ) Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Humenick Six-point engorgement scale ,Duration of breastfeeding post treatment days,Complication: mastitis, breast abscess post treatment number of complication

—

Countries

Thailand

Contacts

Public ContactSupattana Chatromyen

Department of Rehabilitation faculty of medicine Chiang Mai university

dfondsupattana@gmail.com+66869976227

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026