Physical Therapy Intervention for Puerperal Mastitis

National Cheng Kung University

Status: Completed

Conditions: Mastitis

Treatments: Other: Education; Other: Breast massage; Other: Sham ultrasound; Other: Therapeutic ultrasound; Other: Usual obstetric care

Study type: Interventional

Funder types: Other

Identifiers

NCT04569136

MOST 109-2314-B-006-041-MY3

Details and patient eligibility

About

Puerperal mastitis is one of the most commonly reported problems during breastfeeding. Women frequently report breast pain, tenderness, redness, engorgement, fever, malaise, chills, lethargy, sweating, headache, nipple damage and a hot spot on the affected breast. These highly distressing symptoms may severely impact on a woman's daily activities and quality of life and might lead to the premature cessation of exclusive breastfeeding, which may have significant impact on infant health and survival. The role of physical therapy in reducing pregnancy/postpartum-related disorders including breast problems is gaining momentum and importance in obstetrics. However, to date, only low-level evidence has shown positive effects of breast massage, a physical technique, on pain, milk supply and symptom relief in women with breastfeeding problems. This is encouraging, however further research is needed to explore whether physical therapy is effective to reduce symptoms of puerperal mastitis. The investigators will conduct a prospective, assessor blinded single-center randomized controlled trial to assess the effectiveness of an individualized physical therapy program with therapeutic ultrasound, education and massage for patients with puerperal mastitis, compared to patients receiving usual obstetric care and sham ultrasound treatment.

Full description

The high incidence of mastitis in breastfeeding women places health professionals working with postpartum women in key positions for managing women for symptoms of mastitis. This study aims to investigate the effectiveness of a physical therapy program for mastitis. The data the investigators collect from this study will provide evidence on effective and targeted strategies to achieve the goals of acceptable, effective and low risk physical therapy treatment of mastitis in postpartum women. Once these perspectives are known, recommendations on mastitis management can be made.

Enrollment: 37 patients

Sex: Female

Ages: 21 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have given birth at National Cheng Kung University Hospital (NCKUH)
• Are Breastfeeding
• Are aged 21-35
• Are diagnosed with early stage mastitis
• Have sufficient Chinese/Mandarin language skills to participate

Exclusion criteria

• History of breast reduction or augmentation
• An abscess
• Severe physical/psychiatric impairments
• Presence of any malignancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 3 patient groups

Intervention group

Experimental group

Description:

* Educating the patient about mastitis and self-management strategies * Treating with therapeutic ultrasound * Administering and teaching breast massage

Treatment:

Other: Therapeutic ultrasound

Other: Breast massage

Other: Education

Sham group

Sham Comparator group

Description:

* Educating the patient about mastitis and self-management strategies * Receiving sham ultrasound * Administering and teaching breast massage

Treatment:

Other: Sham ultrasound

Other: Breast massage

Other: Education

Usual care group

Other group

Description:

Receiving usual obstetric care, which may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff

Treatment:

Other: Usual obstetric care