Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement

Study Overview
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Brief Summary
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A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.

Detailed Description
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Participants will receive once a day, three consecutive days of interventions in each group, including identical routine care. On each visit, severity index (SI) subject to the extent of erythema, tension and pain over breast will be assessed. Questionnaires of Breastfeeding Self-Efficacy Scale (BSES-SF) and of Edinburgh postnatal depression scale (EPDS) will be performed. Heart-rate variability was evaluated and recorded via a real-time handheld HRV device. Oxycontin, Cortisol, sodium and potassium levels in breastmilk will be tested . A telephone follow-up will be performed in 30 days after completion of treatment, and the data will be collected and analyzed.

Official Title
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Comparing the add-on Effectiveness of Electro-acupuncture or Transcutaneous Electrical Nerve Stimulation in Early Postpartum Breast Engorgement: A Pilot Randomized Pragmatic Trial

Conditions
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Breast Engorgement in Puerperium, Post Partum Depression

Intervention / Treatment
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* Other: Routine care
* Procedure: Electrical Acupuncture
* Procedure: Transcutaneous Electrical Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age > 37 wk Delivery of singleton, healthy newborn baby Within 7 days postpartum Within 24 hours from initial painful breast engorgement Difficulty on lactation due to plugged ducts, SI index ≧ 5 (0-19) Exclusion Criteria: Fever>37.5∘C Mastitis or breast abscess Signs of sepsis or other infection Perinatal mother and infant diseases (Gestational hypertension、Gestational Diabetes Mellitus、Pre-eclampsia 、Gestational thyroid diseases or Intrauterine growth retardation) Psychological diseases Bleeding tendency Artificial valves Pacemaker Epilepsy Consciousness disturbance Skin infections Hepatitis B carrier Acquired Immune Deficiency Syndrome Breast tumors Breast Surgeries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Routine care<br>Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk. | Other: Routine care<br>* Reverse pressure applied to the areola<br>|
| Experimental: Routine care plus EA<br>Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk. plus: Electrical acupuncture on body acupoints | Other: Routine care<br>* Reverse pressure applied to the areola<br>Procedure: Electrical Acupuncture<br>* Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation<br>|
| Experimental: Routine care plus TENS<br>Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk. plus: Transcutaneous electrical nerve stimulation on breasts | Other: Routine care<br>* Reverse pressure applied to the areola<br>Procedure: Transcutaneous Electrical Nerve Stimulation<br>* Transcutaneous electrical nerve stimulation over bil breasts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity Index (0-19) | Sum of the degree of Erythema, Tension and Pain scores over breasts | Changes from Baselines of Severity Index, at each treatment and 1 month later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPDS | Edinburgh Postnatal Depression Scale | Changes from Baseline of EPDS, after each treatment and 1 month later | 
| BSES-SF | Breastfeeding Self-Efficacy Scale | Changes from Baseline of BEES-SF, after each treatment and 1 month later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical acupuncture, Transcutaneous Electrical Nerve Stimulation