Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

Study Overview
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Brief Summary
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This study was meant to see the effectiveness of press tack needle acupuncture in improving lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1 Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it will give continuous acupuncture stimulation that might help in improving lactation insufficiency with minimal side effect, less time consuming, and more efficient for the patient.

Official Title
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Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

Conditions
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Lactation; Insufficient, Partial, Hypogalactia, Without Mention of Attachment Difficulty

Intervention / Treatment
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* Device: Press Tack Needle Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breastfeeding mother who suffers from lactation insufficiency Breastfeeding mother from 2 weeks to 5 months post-partum Breastfeeding mother with healthy baby Exclusion Criteria: Subject consumes drugs that are known to decrease breastmilk production Subject with infection or inflammation in the intended acupuncture points Subject with bleeding disorder Subject consumes anticoagulant Subject with known diabetic history Subject with body temperature > 38 degree celcius

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Press Tack Needle Acupuncture<br>Patients in this group were given seirin pyonex press tack needle treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days. | Device: Press Tack Needle Acupuncture<br>* Seirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point<br>|
| Sham Comparator: Sham Control Press Tack Needle Acupuncture<br>Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days. | Device: Press Tack Needle Acupuncture<br>* Seirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastmilk Volume | Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump | Day 7 of acupuncture or sham treatment | 
| Breastmilk Volume | Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump | Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, exclusive breastfeeding, breastmilk, press tack needle, lactation insufficiency