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临床试验/NCT03806062
NCT03806062已完成4 期

EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
serum prolactin

研究概览

简要总结

A randomized controlled study conducted on 60 healthy primiparous mothers with insufficient lactation. The participants were divided randomly into three equal groups, Group (A) control, Group (B) received low power He-Ne laser beam on both breasts and Group (C) received faradic current stimulation at Spleen 6, Liver 3 and Small Intestine 1 acupuncture points on both sides, all participants received 10 mg domperidone 3 times a day and advice about lactation, nutrition and fluid intake. Evaluation was done before and after the treatment program

详细描述

Women in Group (A) acted as a control group and only received medical treatment in the form of 10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks) Each woman in group (B) lied in supine lying position on the treatment plinth wearing the protective eyewear as precautionary measures for her safety and exposing her breast out of her clothes then the breast was cleaned by alcohol. The laser apparatus was directed perpendicularly over the treated breast at a distance 50 cm from it, all metal objects must be removed from the range of action of laser (i.e. necklaces). The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session the machine switched off automatically then, it was adjusted again to start irradiation by the same procedures for the other breast. The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions). He-Ne laser (Bravo TrezaSerie) device was used. The equipment was designed in compliance with international technical standards UNI EN ISO 9002 and En 46002 and complies with the safety requirements.

Group (B) had received 12 sessions of irradiation by low power He-Ne laser beam on both sides of the breasts 10 minutes on each side. One session every other day, three sessions weekly for four weeks beside the medical treatment (10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period Group (C) women were treated by faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze) using surface electrodes in addition to medical treatment (10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake allthrough the treatment period

SP-6 Acupuncture Point lies on the inner leg aspect about 3 cm higher than the medial malleolus, along the posterior tibial border. Fig. (2)

LIV-3 Acupuncture Point is the one that lies in the depressed area between the 1st 2 metatarsal bones proximal to the metatarsophalangeal joints on the dorsal foot aspect Fig. (2)

SI.1 Acupuncture point is located on the little finger, ulnar to the distal phalanx, at the intersection of the vertical line of ulnar border of the nail and the horizontal line of the base of the little fingernail. Fig. (2)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Their age ranged between 20 and 35 years old
  • 25 to 30 kg/m² body mass index (BMI).
  • They attended the breast feeding clinic complaining from insufficiency of lactation within the 1st month after normal vaginal delivery and they were using mixed feeding (Both breast and bottle feeding at least 3 bottles per day and not more than 6 bottles).
  • They had approximately the same nutrition as well as, education level

排除标准

  • lactating mothers who suffered from post-partum hemorrhage
  • cardio respiratory disease
  • diabetes mellitus
  • breast cancer
  • previous surgeries in the chest, breast or the surrounding area
  • those who had any causes that hindering their normal breast feeding as (retraced, cracked, inflamed or inverted nipples)
  • Women receiving contraceptive pills,
  • conditions related to the infant that affect the lactation process were excluded such as congenital conditions of infant mouth: tongue tie, cleft of the soft palate and congenital heart disease of the infant

研究组 & 干预措施

control group

Active Comparator

10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks)

干预措施: domperidone (Drug)

Laser group

Active Comparator

The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session on both breasts.

The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions)

干预措施: domperidone (Drug)

Laser group

Active Comparator

The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session on both breasts.

The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions)

干预措施: He-Ne laser (Bravo TrezaSerie) device (Device)

Electro acupuncture group

Active Comparator

faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze) using surface electrodes

干预措施: domperidone (Drug)

Electro acupuncture group

Active Comparator

faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze) using surface electrodes

干预措施: faradic current (Device)

结局指标

主要结局

serum prolactin

时间窗: 12 weeks after treatment

the mean difference in the value of serum prolactin between the three studied groups measured at post-treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Principal investigator

Cairo University

研究点 (1)

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