Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

Not Applicable

Completed

• Conditions: Lactation; Insufficient, Partial; Hypogalactia, Without Mention of Attachment Difficulty
• Interventions: Device: Press Tack Needle Acupuncture

• Registration Number: NCT04416880
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-13
• Primary Completion: 2020-02-18
• Study Completion: 2020-02-18
• Status Verified: 2020-06
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Last Update Submitted: 2020-06-03
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Control Press Tack Needle Acupuncture	Press Tack Needle Acupuncture	Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.
Press Tack Needle Acupuncture	Press Tack Needle Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Breastmilk Volume	Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)	Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump

Trial Locations

Locations (3)

Poliklinik Akupunktur Medik RSCM; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

Puskesmas Kelurahan Pegangsaan; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

Puskesmas Kecamatan Menteng; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia