Low-Level Laser Therapy (LLLT) Treatment for Breast-Feeding Women With Painful Nipple Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low-Level-Lasertherapie (LLLT) Bei Schmerzhaften, Wunden Mamillen Stillender Frauen

Conditions
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Nipple Lesions

Intervention / Treatment
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* Device: Low-Level Laser Therapy
* Device: Placebo Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: prospective, randomized double-blinded study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Level Laser Therapy<br>During 2-3 days this group receives three low-level laser therapy (LLLT) treatments with the Soft Power Laser carried out by a specially trained breastfeeding consultant. | Device: Low-Level Laser Therapy<br>* The low-level laser emits monochromatic, coherent, bundled laser light. In each therapy a energy dose of 2-4 Joul (J) / centimeter (cm)^2 is applied over a duration of about 30 seconds using level 1 (20 percent of maximum output) of the 350 milliwatt (mW) device.<br>|
| Placebo Comparator: Placebo Therapy<br>During 2-3 days this group receives three placebo treatments with an identically looking laser, which in contrast submits only red colored light. The therapy is also carried out by a specially trained breastfeeding consultant. | Device: Placebo Therapy<br>* The intervention is conducted identically to the low-level laser therapy but the placebo laser that is used emits only red light that is polychromatic, leading to a reduction in energy being emitted and therewith to no or a smaller effect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction: visual pain scale | The primary goal is to evaluate the pain reduction with the help of a visual pain scale form 1 to 10 (0 = no pain; 10 = pain as bad as can be). | though individual study completion, an average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing | One secondary goal is to evaluate the effect of the low-level laser therapy (LLLT) on wound healing. For this evaluation the nipple lesions are staged from 1-4 and photo documented and inflammatory markers (C reactive protein (CRP) and leucocytes (Lc)) and modulators (interleukin 6 (IL6) and tumor necrosis factor alpha (TNF-a) are analyzed in the blood. | though individual study completion, an average of 3 days | 
| Milk Production | Another secondary goal is to evaluate the effect of the low-level laser therapy (LLLT) on milk production. This is done through measuring the milk production after 15 minutes pumping of both breasts and analyzing the prolactin in the blood. | though individual study completion, an average of 3 days | 
| Satisfaction with the low-level laser therapy (LLLT): visual analogue scale | An additional secondary goal is to evaluate the participants' degree of satisfaction with the LLLT. This is accomplished with the help of a visual analogue scaled. | though individual study completion, an average of 3 days |