Low-Level Laser Therapy (LLLT) Treatment for Breast-Feeding Women With Painful Nipple Lesions
Low-Level Laser Therapy (LLLT) Treatment for Breast-Feeding Women With Painful Nipple Lesions
Around 30 to 90 percent of all breastfeeding women suffer from painful and sore nipple
 lesions. Reasons for these lesions are still not completely clarified. Nevertheless,
 irrespective of the underlying cause, these painful nipple lesions lead to an early stop of
 breastfeeding, which has negative consequences for the infant as well as for the mother. Even
 if the painful nipple lesions do not lead to a weaning of the baby, they cause an increased
 psychological distress for the mother and therefore may negatively influence the mother-child
 relationship.

 Since breastfeeding is the natural and best possible type of nutrition for healthy, full term
 babies problems causing an early stop of breastfeeding should be addressed.

 The low-level laser therapy (LLLT) represents a simple and low risk treatment to reduce pain
 and accelerate wound healing. It is supposed to improve tissue organization and should have a
 positive anti-inflammatory and immune modulating effect. Therefore, this therapy is more and
 more frequently used to also treat painful nipple lesions, although hardly any studies have
 been conducted. Furthermore, in women with too little mother milk, the LLLT seems to increase
 the milk production.

 The aim of this study is to investigate the positive effects of LLLT on painful and sore
 nipple lesions. This would justify a LLLT for women with painful nipple lesions on a wider
 scale, with the overall goal to reduce early stopping of breastfeeding and therefore having a
 positive impact on both, the child's health as well as the mother's wellbeing.
This study is conducted at the department of obstetrics of the University hospital of Zurich.
 194 breastfeeding or expressing participants with sore and painful nipple lesions who fulfill
 the inclusion criteria are included in this study. If the participant meets any exclusion
 criteria she is excluded from this study. After being enrolled in the study, the participant
 is randomized to get either 3 low-level laser therapy (LLLT) treatments or 3 placebo
 treatments within 1 to 3 days.

 Women having signed the declaration of consent and fulfill all inclusion criteria are then
 examined by a breastfeeding consultant. During this examination nipple lesions are classified
 into four different stages, causes for the lesions are evaluated and the nipple form is
 recorded. A swab of the milk is taken to rule out a pathogenetic colonization with germs.
 Then a blood sample is collected to analyze inflammatory parameters (C-reactive protein
 (CRP), leucocyte (Lc)), inflammation modulators (interleukin 6 (IL-6), tumor necrosis factor
 alpha (TNF-α)) and the lactating hormone (prolactin). The taking of blood is repeated at the
 end of the third therapy. In the beginning and at the end of the last treatment, nipple
 lesions are classified and photographically documented. Specific instructions regarding the
 correct positioning and removal of the baby at the breast as well as breastfeeding positions
 are given to the women before starting the treatment. Women then breastfeed their baby once
 before and once after the entire therapy. Two hours after breastfeeding, the amount of milk
 is being measured after 15 minutes of pumping. Additionally, the sensation of pain is
 evaluated on the basis of a visual analog scale (VAS) from 1-10 and the satisfaction of the
 treatment is recorded before and after every single treatment. At the end of the last
 therapy, a final examination is conducted.

 For the statistical analysis of the primary and secondary endpoints a proportional odds model
 is used.
Inclusion Criteria:

 -  signed written informed consent form

 -  breast-feeding or pumping participant with painful nipple lesions

 -  18 years or older

 Exclusion Criteria:

 -  contraindication for the class of medical device used or intervention being performed
 e.g.

 known hypersensitivity or allergy against the medical device or class of medical device

 -  missing willingness to take part in the study

 -  hepatitis B or C positive

 -  human immunodeficiency virus (HIV) positive

 -  intake of immunosuppressive drugs

 -  epilepsy

 -  dark or tattooed skin

 -  laking German skills

 -  mamma carcinoma in past medical history

 -  severe infection (C-reactive protein (CRP) >200mg/l; leucocytes >20000/ul)