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

NCT04259619 | Terminated DMC

• 1 other identifier: 2019-01374
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Nipple Lesions

Outcome Measures

Primary Outcomes (1)

• Pain Reduction: visual pain scale from 1 (no pain) to 10 (worst pain)

  The primary goal is to evaluate the pain change with the help of a visual pain scale form 1 to 10 (0 = no pain; 10 = worst pain).

  though individual study completion, an average of 3 days

Secondary Outcomes (3)

• Wound Healing

  though individual study completion, an average of 3 days

• Milk Production

  though individual study completion, an average of 3 days

• Satisfaction with the low-level laser therapy (LLLT): visual analogue scale from 1 (low satisfaction) to 10 (highest satisfaction)

  though individual study completion, an average of 3 days

Study Arms (2)

Low-Level Laser Therapy

EXPERIMENTAL

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

Placebo Therapy

PLACEBO COMPARATOR

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

Interventions

Low-Level Laser Therapy DEVICE

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.

Low-Level Laser Therapy

Placebo Therapy DEVICE

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.

Placebo Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed written informed consent form
• breast-feeding or pumping participant with painful nipple lesions
• years or older

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Nicole Ochsenbein-Kölble, Prof.Dr.med.

  leading physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The low-level laser and the placebo-laser cannot be differentiated visually. The lasers are marked with the names "Geraet1" and "Geraet2". The therapy is carried out identical in the way of application, duration and preventive measures. After the participant is randomized, the study nurse hands out the corresponding laser for the therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized double-blinded study

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 6, 2020
• Study Start: March 2, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CH (1)