Physical Therapy Intervention for Puerperal Mastitis

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    75
  • sponsor
    National Cheng Kung University
Updated on 18 February 2021

Summary

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.

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.

Details
Condition Mastitis
Treatment Education, Therapeutic ultrasound, Sham ultrasound, Breast massage, Usual obstetric care
Clinical Study IdentifierNCT04569136
SponsorNational Cheng Kung University
Last Modified on18 February 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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