Physical Therapy Intervention for Puerperal Mastitis in Breastfeeding Women
Phase: NA
Conditions: Mastitis
Sponsor: National Cheng Kung University

 
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Official title: Physical Therapy Intervention for Puerperal Mastitis 
Number: NCT04569136 
Document date: 04/01/2022 
 
Introduction 
Puerperal mastitis is one of the most commonly reported problems during 
breastfeeding (1-3). Women frequently report breast pain, tenderness, redness, 
engorgement, fever, malaise, chills, lethargy, sweating, headache, nipple damage and 
a hot spot on the affected breast (4-6). 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 (7). 
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 (7). This is encouraging, however further research is 
needed to explore whether physical therapy is effective to reduce symptoms of 

 
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puerperal mastitis. Therefore, the aims of this study were to explore clinical effects of 
therapeutic ultrasound, education and massage on mastitis symptoms and to compare 
the effectiveness of therapeutic ultrasound, education and massage versus usual 
obstetric care and sham ultrasound treatment on patient-centered outcomes in the 
short- and medium-term.  
 
Methods 
A randomized controlled trial was conducted from May 2021 to April 2023. 
Postpartum lactating women aged from 21 to 45 with breast symptoms were recruited 
through the Obstetrics and Gynecology Clinic of National Cheng Kung University 
Hospital, the postpartum care centers, websites and community. Eligible participants 
were randomly allocated to the ultrasound group, sham group, or usual care group. 
Participants allocated to the ‘Ultrasound’ arm of the trial participated in four one-hour 
treatment sessions with the physical therapist over one week. The treatment included 
educating the patient about mastitis and self-management strategies, treating with 
therapeutic ultrasound and administering and teaching breast massage. Participants 
allocated to the ‘Sham’ group received the same education and breast massage 
sessions as described above. In addition, the sham control group received 5 minutes of 
‘sham’ ultrasound at 0 W/cm2 intensity from a physical therapist. Participants 

 
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allocated to the ‘Usual care’ group received usual obstetric care, which included 
verbal advice/printed patient information regarding mastitis and breastfeeding from 
the medical or nursing staff. The outcome measures including severity of breast 
symptoms (breast and nipple pain, breast engorgement), breast hardness, body 
temperature, breast temperature, breastfeeding self-efficacy, and milk volume were 
assessed at baseline, immediately post-intervention, and at 3 months following 
baseline. The acceptability of the intervention program and adverse events were 
recorded immediately post-intervention and at 3 months following baseline.  
 
Statistical analysis plan 
The data were analyzed using intention-to-treat principles with the SPSS version 20.0 
for Windows. The last observation carried forward imputation was used for imputing 
missing data. Descriptive statistics were used to summarize and report data. All 
outcome data were assessed for normality using the Kolmogorov-Smirnov test. 
Repeated measures analysis of variance with Bonferroni post hoc comparisons was 
used to compare changes in outcome variables between groups. The equivalent non-
parametric tests (i.e. Friedman test and Kruskal Wallis test) were used if data were not 
normally distributed. Numbers, percentages, mean, standard deviation, median, 
interquartile range, and p-values were reported. All analyses were tested with a 

 
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significance level of p<0.05. 
 
References 
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Foxman B, D'Arcy H, Gillespie B, Bobo JK, Schwartz K. Lactation mastitis: 
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United States. Am J Epidemiol. 2002;155(2):103-14 

 
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7. 
Mangesi L, Zakarija-Grkovic I. Treatments for breast engorgement during 
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