Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569136
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2020-09-23
Brief Title:
Physical Therapy Intervention for Puerperal Mastitis
Sponsor:
National Cheng Kung University
Organization:
National Cheng Kung University
Study Overview
Official Title:
Physical Therapy Intervention for Puerperal Mastitis in Breastfeeding Women
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 womans 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 pregnancypostpartum-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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None