N/A
N=37
Physical Therapy Intervention for Puerperal Mastitis
Mastitis
Bottom Line
View on ClinicalTrials.gov: NCT04569136 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Breast and Nipple Pain — 0; 0; 1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education (Other); Therapeutic ultrasound (Other); Sham ultrasound (Other); Breast massage (Other); Usual obstetric care (Other)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- National Cheng Kung University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast and Nipple Pain |
0; 0; 1 | — |
| SECONDARY Severity of Breast Engorgement |
1; 1.5; 2 | — |
| SECONDARY Breast Hardness |
5.2; 1.0; 2.3 | — |
| SECONDARY Body and Breast Temperature |
36.9; 36.7; 37.0 | — |
| SECONDARY Volume of Mother's Milk |
52.2; 17.8; 40.7 | — |
| SECONDARY Acceptability of the Intervention Program |
11; 11; 7 | — |
| SECONDARY Number of Participants Reporting Adverse Events |
0; 0; 0 | — |
| SECONDARY Breastfeeding Self-efficacy |
52.0; 59.5; 55 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04569136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.