Physical Therapy Intervention for Puerperal Mastitis

Physical Therapy Intervention for Puerperal Mastitis in Breastfeeding Women

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.

Study Overview

• Status: Recruiting
• Conditions: Mastitis
• Intervention / Treatment: Other: Education; Other: Therapeutic ultrasound; Other: Breast massage; Other: Sham ultrasound; Other: Usual obstetric care

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kuan-Yin Lin, PhD; Phone Number: 6737 +886-6-2353535; Email: 10802003@gs.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University
    • Contact: Kuan Yin Lin; Phone Number: 5931 +886 62353535; Email: 10802003@gs.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Educating the patient about mastitis and self-management strategies; Treating with therapeutic ultrasound; Administering and teaching breast massage	Other: Education; The education session including education about mastitis, feeding techniques, lifestyle changes, thermal/cryo therapy and demonstration of breast self-massage will take approximately 20 minutes.; Other: Therapeutic ultrasound; Participants will be treated with 5 minutes of therapeutic ultrasound (pulsed mode) at a frequency of 1 Mega Hertz, a duty cycle of 20%, a pulse intensity of 1.8 Watt/centimetre squared. The ultrasound probe will be moved at a speed of about 4 centimetre/second. The intensity and duration will be adjusted if the patient complains of discomfort. The ultrasound transducer head will massage over the tender point on the breast.; Other: Breast massage; Breast massage includes general and focused massage. Participants will lie in supine position. The breast massage will be applied according to the Vodder method to the affected breast.
Sham Comparator: Sham group; Educating the patient about mastitis and self-management strategies; Receiving sham ultrasound; Administering and teaching breast massage	Other: Education; The education session including education about mastitis, feeding techniques, lifestyle changes, thermal/cryo therapy and demonstration of breast self-massage will take approximately 20 minutes.; Other: Breast massage; Breast massage includes general and focused massage. Participants will lie in supine position. The breast massage will be applied according to the Vodder method to the affected breast.; Other: Sham ultrasound; Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.
Other: Usual care group; Receiving usual obstetric care, which may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff	Other: Usual obstetric care; Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast and nipple pain	Breast and nipple pain in the past 24 hours will be assessed using the numerical rating scale (NRS). Participants will be asked to rate her breast pain and nipple pain from 0 to 10 (11 point scale), with 0 indicating no pain and 10 indicating the worst possible pain.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of breast engorgement	The degree of breast engorgement of the left and right breasts will be assessed using a six-point engorgement scale developed by Hill and Humenick. The higher scores indicate more severe breast engorgement (1=soft, no change, 2=slight change, 3=firm, non-tender, 4=firm, beginning tenderness, 5=firm, tender, 6=very firm and very tender).	3 months
Breast hardness	The assessor will use a portable durometer to measure the hardness of left and right breasts. The participant will lie in a supine position and the durometer will be placed at 3 cm from both nipples in the 10 o'clock and 2 o'clock positions. The spring-loaded presser is pressed downwards until trigger switch on. Each position will be measured three times and the mean value will be obtained.	3 months
Body and breast temperature	Core body and breast temperatures will be measured using a non-contact infrared thermometer on the central part of the forehead and in the area 3 cm from both nipples in the 10 o'clock and 2 o'clock positions, respectively. The temperature of each position will be measured three times and the mean value will be recorded.	3 months
Volume of mother's milk	The volume of mother's milk will be measured by an electric breast pump for 15 minutes. Milk volumes will be recorded by weighing the collecting bottle on an electronic digital scale to the nearest 0.1 gram before and after each expression.	3 months
Acceptability of the intervention program	Acceptability of the intervention program will be assessed immediately post-intervention using a short questionnaire with 5-point Likert scale response to questions of 'how acceptable did you find the physical therapy interventions used in this study?' and 'how would you rate your overall satisfaction with the physical therapy program?' from 1 to 5, with 1 indicating very low acceptability or satisfaction and 5 indicating very high acceptability or satisfaction.	3 months
Number of participants reporting adverse events	Adverse events will be recorded and reported as per Institutional Review Board, National Cheng Kung University Hospital guidelines on reporting adverse events and serious adverse events, with the absence of adverse or serious adverse events related to the physical therapy intervention used to indicate safety of the trial protocol.	3 months

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Kuan-Yin Lin, PhD, National Cheng Kung University

Publications and helpful links

General Publications

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
• Diepeveen LC, Fraser E, Croft AJE, Jacques A, McArdle AM, Briffa K, McKenna L. Regional and Facility Differences in Interventions for Mastitis by Australian Physiotherapists. J Hum Lact. 2019 Nov;35(4):695-705. doi: 10.1177/0890334418812041. Epub 2018 Nov 27.
• Kasseroller RG. The Vodder School: the Vodder method. Cancer. 1998 Dec 15;83(12 Suppl American):2840-2. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.0.co;2-5.
• Lavigne V, Gleberzon BJ. Ultrasound as a treatment of mammary blocked duct among 25 postpartum lactating women: a retrospective case series. J Chiropr Med. 2012 Sep;11(3):170-8. doi: 10.1016/j.jcm.2012.05.011.
• McLachlan Z, Milne EJ, Lumley J, Walker BL. Ultrasound treatment for breast engorgement: A randomised double blind trial. Aust J Physiother. 1991;37(1):23-8. doi: 10.1016/S0004-9514(14)60531-6.
• Witt AM, Bolman M, Kredit S, Vanic A. Therapeutic Breast Massage in Lactation for the Management of Engorgement, Plugged Ducts, and Mastitis. J Hum Lact. 2016 Feb;32(1):123-31. doi: 10.1177/0890334415619439. Epub 2015 Dec 7.
• Wong RA, Schumann B, Townsend R, Phelps CA. A survey of therapeutic ultrasound use by physical therapists who are orthopaedic certified specialists. Phys Ther. 2007 Aug;87(8):986-94. doi: 10.2522/ptj.20050392. Epub 2007 Jun 6. Erratum In: Phys Ther. 2007 Sep;87(9):1258.
• Hill PD, Humenick SS. The occurrence of breast engorgement. J Hum Lact. 1994 Jun;10(2):79-86. doi: 10.1177/089033449401000212.
• Lim AR, Song JA, Hur MH, Lee MK, Lee MS. Cabbage compression early breast care on breast engorgement in primiparous women after cesarean birth: a controlled clinical trial. Int J Clin Exp Med. 2015 Nov 15;8(11):21335-42. eCollection 2015.
• Geissler NJ. An instrument used to measure breast engorgement. Nurs Res. 1967 Spring;16(2):130-6. No abstract available.
• Mori H, Uemura N, Koga H, Okazaki M. Objective assessment of reconstructed breast hardness using a durometer. Breast Cancer. 2018 Jan;25(1):81-85. doi: 10.1007/s12282-017-0791-y. Epub 2017 Jun 23.
• Teran CG, Torrez-Llanos J, Teran-Miranda TE, Balderrama C, Shah NS, Villarroel P. Clinical accuracy of a non-contact infrared skin thermometer in paediatric practice. Child Care Health Dev. 2012 Jul;38(4):471-6. doi: 10.1111/j.1365-2214.2011.01264.x. Epub 2011 Jun 8.
• Jones E, Dimmock PW, Spencer SA. A randomised controlled trial to compare methods of milk expression after preterm delivery. Arch Dis Child Fetal Neonatal Ed. 2001 Sep;85(2):F91-5. doi: 10.1136/fn.85.2.f91.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Mastitis
• Other Study ID Numbers: MOST 109-2314-B-006-041-MY3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Clinical Study Report
   Information identifier: DOI：10.6315/2009.37(4)06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No