Clinical trial NCT04259619: Low-Level Laser Therapy (LLLT) Treatment for Breast-Feeding Women With Painful Nipple Lesions
Official title: Low-Level-Lasertherapie (LLLT) Bei Schmerzhaften, Wunden Mamillen Stillender Frauen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nipple Lesions
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized double-blinded study
Primary purpose: TREATMENT

Brief summary: 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 change (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.

Detailed description: 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.

Eligibility criteria: 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
* lacking German or English skills
* mamma carcinoma in past medical history
* severe infection (C-reactive protein (CRP) \>200mg/l; leucocytes \>20000/ul)

Primary outcomes:
measure: Pain Reduction: visual pain scale from 1 (no pain) to 10 (worst pain)
timeFrame: though individual study completion, an average of 3 days
Secondary outcomes:
measure: Wound Healing
timeFrame: though individual study completion, an average of 3 days
measure: Milk Production
timeFrame: though individual study completion, an average of 3 days
measure: Satisfaction with the low-level laser therapy (LLLT): visual analogue scale from 1 (low satisfaction) to 10 (highest satisfaction)
timeFrame: though individual study completion, an average of 3 days
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
affiliation: leading physician
name: Nicole Ochsenbein-Kölble, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: