Low-Level Laser Therapy (LLLT) Treatment for Breast-Feeding Women With Painful Nipple Lesions
NCT ID: NCT04259619
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
194 participants
INTERVENTIONAL
2020-03-02
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Laser Therapy in Nipples Injured During Breastfeeding
NCT01723995
Effect of LED Therapy for Treatment Nipple Fissure
NCT03496753
Physical Therapy Intervention for Puerperal Mastitis
NCT04569136
Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties
NCT00970255
Healing Nipple Wounds: Comparison Between 2 Treatment Modalities
NCT03389516
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low-Level Laser Therapy
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.
Low-Level Laser Therapy
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.
Placebo Therapy
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.
Placebo Therapy
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low-Level Laser Therapy
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.
Placebo Therapy
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* breast-feeding or pumping participant with painful nipple lesions
* 18 years or older
Exclusion Criteria
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)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicole Ochsenbein-Kölble, Prof.Dr.med.
Role: PRINCIPAL_INVESTIGATOR
leading physician
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-01374
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.